natgillin/translations-raw huggingface dataset:
In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and
U slučaju predoziranja potrebno je pratiti vitalne znakove bolesnika te im pružiti odgovarajuće potporne mjere za održavanje krvnog tlaka (kao što je tekućina, presorni lijekovi i/ili inotropni lijekovi) i tjelesne temperature (vidjeti dijelove 4.2 i 4.4).
Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Sekundarne mjere ishoda djelotvornosti uključile su posttransplantcijske stope odgovora (CR+nCR, CR+nCR+VGPR+PR), preživljenje bez progresije i ukupno preživljenje.
Peri- and postnatal development studies were not conducted.
Nisu provedena ispitivanja utjecaja na perinatalni i postnatalni razvoj.
What Bortezomib SUN is and what it is used for
Što je Bortezomib SUN i za što se koristi
Normal liver function should be confirmed and caution should be exercised in patients receiving oral hypoglycemics (see section 4.5).
Potrebno je potvrditi normalnu funkciju jetre i s oprezom pristupiti bolesnicima koji uzimaju oralne hipoglikemike (vidjeti dio 4.5).
Patients should be instructed to seek medical advice if they experience symptoms of dizziness, light-headedness or fainting spells.
Bolesnike se mora uputiti da potraže liječnički savjet ako osjete simptome omaglice, ošamućenosti ili nesvjestice.
The resulting solution is then either injected into a vein or under the skin.
Ta se otopina zatim daje injekcijom ili u venu ili pod kožu.
Rare side effects (may affect up to 1 in 1,000 people) - blood clot in small blood vessels (thrombotic microangiopathy)
Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) - krvni ugrušak u malim krvnim žilama (trombotička mikroangiopatija).
* Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate, severe).
* Prema klasifikaciji Radne skupine za poremećaj funkcije organa Nacionalnog instituta za rak za kategorizaciju oštećenja jetre (blago, umjereno, teško).
In the BzmbTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
U BzmbTDx skupini 12 % bolesnika bili su citogenetički svrstani u skupinu visokog rizika naspram 16 % bolesnika u TDx skupini.
The incidence of death on treatment was 5% in the subcutaneous treatment group and 7% in the intravenous treatment group.
Incidencija smrti za vrijeme liječenja bila je 5 % u skupini liječenoj supkutano a 7 % u skupini liječenoj intravenski.
One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib-containing regimen were retreated upon progression.
Stotinu i trideset bolesnika (≥ 18 godina starosti) s multiplim mijelomom koji su prethodno imali barem parcijalan odgovor na režim koji je uključivao bortezomib bilo je ponovno liječeno nakon progresije.
Rest period
Period odmora
Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Periferna neuropatija stupnja ≥3 pojavila se kod 6 % bolesnika u skupini liječenoj supkutano, u usporedbi sa 16 % u skupini liječenoj intravenski (p=0,0264).
≤ 1.0 x ULN
≤ 1,0 x GGN
Patients with risk factors for or existing heart disease should be closely monitored.
Bolesnike s čimbenicima rizika za razvoj ili s postojećom bolešću srca mora se pomno pratiti.
Secondary efficacy endpoints included Progression Free Survival and Overall Survival.
Sekundarne mjere ishoda uključile su preživljenje bez progresije i ukupno preživljenje.
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.
Ovo ispitivanje doseglo je svoj primarni cilj, neinferiornost u stopi odgovora (CR+PR) nakon 4 ciklusa samostalno primijenjenog bortezomiba za oba puta primjene, i supkutano i intravenski, 42 % u obje skupine.
Also included are adverse drug reactions identified in the BzmbR-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.
Također su uključene nuspojave identificirane u skupini BzmbRCAP za koje su ispitivači smatrali da imaju barem moguću ili vjerojatnu uzročnu povezanost s bortezomibom na temelju na povijesnih podataka u ispitivanjima multiplog mijeloma.
- The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
- Rekonstituirana otopina primjenjuje se supkutano u bedro (desno ili lijevo) ili abdomen (desnu ili lijevu stranu).
Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BzmbDx groups respectively; the majority of patients underwent one single transplant procedure.
Autologne transplantate matičnih stanica primilo je 198 (82 %) bolesnika odnosno 208 (87 %) bolesnika u VDDx i BzmbDx skupinama; većina bolesnika prošla je jednu transplantaciju.
What Bortezomib SUN is and what it is used for What you need to know before you are given Bortezomib SUN How to use Bortezomib SUN
Što je Bortezomib SUN i za što se koristi Što morate znati prije nego što počnete primati Bortezomib SUN
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.
Pokusi su pokazali da je bortezomib citotoksičan za razne vrste stanica raka i da su stanice raka osjetljivije od normalnih stanica na proapoptotičke učinke inhibicije proteasoma.
Taking into account the PRAC Assessment Report on the PSUR(s) for bortezomib, the scientific conclusions of CHMP are as follows:
Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za bortezomib, znanstveni zaključci CHMP-a su sljedeći:
• 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 Setting (Bortezomib SUN plus dexamethasone, and Bortezomib SUN plus dexamethasone and thalidomide).
• upute za propisivanje i primjenu koje uključuju duljinu i broj ciklusa, radi smanjenja rizika medikacijskih pogrešaka i pogrešaka pri pripremi moguće uzrokovane zbog postojanja dva različita režima kombinacije s bortezomibom kod transplantiranih bolesnika (Bortezomib SUN plus deksametazon i Bortezomib SUN plus deksametazon i talidomid).
Based on this review, chalazion/blepharitis is considered associated with the use of bortezomib.
Na temelju ovog pregleda, halacion/blefaritis se smatraju povezanima s primjenom bortezomiba.
When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section).
Kada se primjenjuje talidomid, potrebna je posebna pažnja vezana uz mjere prevencije i testiranje na trudnoću (vidjeti Trudnoća i dojenje u ovom dijelu).
The kinetics of proteasome inhibition were evaluated in vitro, and bortezomib was shown to dissociate from the proteasome with a t½ of 20 minutes, thus demonstrating that proteasome inhibition by bortezomib is reversible.
Kinetika inhibicije proteasoma ocjenjivala se in vitroi pokazalo se da se bortezomib razdvaja od proteasoma uz t½ od 20 minuta, pokazujući tako da je inhibicija proteasoma bortezomibom reverzibilna.
May be fatal if given by other routes.
Primjena drugim putevima primjene može biti smrtonosna.
These effects have been observed in patients with multiple myeloma affected by an advanced osteolytic disease and treated with bortezomib.
Ovi su učinci bili primijećeni u bolesnika s multiplim mijelomom koji su imali uznapredovalu osteolitičku bolest i liječili su se bortezomibom.
All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively.
Periferna neuropatija svih stupnjeva i periferna neuropatija stupnja ≥ 3 bile su uočene u 40 % odnosno 8,5 % bolesnika.
- Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.
Nakon što je otopljena, povucite odgovarajuću količinu rekonstituirane otopine prema dozi izračunatoj na temelju bolesnikove površine tijela.
Be sure that the correct dose is being given for the subcutaneous route of administration (2.5 mg/ml).
Budite sigurni da primjenjujete ispravnu dozu za supkutani put primjene (2,5 mg/ml).
It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells.
On je posebno oblikovan da inhibira aktivnost poput kimotripsina 26S proteasoma u stanicama sisavaca.
Both in patients who were refractory to their last prior therapy and those who were not refractory, overall survival was significantly longer and response rate was significantly higher on the bortezomib arm.
I u bolesnika koji su bili refraktorni na zadnje prethodno liječenje i onih koji nisu bili refraktorni, ukupno preživljavanje bilo je značajno dulje i stopa odgovora bila je značajno viša u skupini koja je primala bortezomib.
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.
Nositelji hepatitisa B i bolesnici s hepatitisom B u anamnezi moraju se strogo nadzirati na kliničke i laboratorijske znakove aktivne infekcije HBV-om tijekom i nakon kombiniranog liječenja rituksimabom i bortezomibom.
The European Medicines Agency has waived the obligation to submit the results of studies with bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja bortezomiba u svim podskupinama pedijatrijske populacije u multiplom mijelomu i u limfomu plaštenih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
- When Bortezomib SUN is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
- Kada se Bortezomib SUN primjenjuje zajedno s talidomidom i deksametazonom, trajanje ciklusa liječenja je 28 dana (4 tjedna).
Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.
Na osnovi ograničenog doprinosa (7 %) enzima CYP2D6 metabolizmu bortezomiba, ne očekuje se da će fenotip slabog CYP2D6 metabolizatora utjecati na cjelokupnu raspoloživost bortezomiba.
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.
Ukupna incidencija proljeva, gastrointestinalne i abdominalne boli, astenijskih stanja, infekcija gornjih dišnih putova i perifernih neuropatija, bila je 12 % - 15 % niža u skupini supkutane primjene nego u intravenskoj skupini.
In dogs, the decreased cardiac contractility and hypotension responded to acute intervention with positive inotropic or pressor agents.
U pasa su smanjena srčana kontraktilnost i hipotenzija reagirale na akutnu intervenciju primjene lijekova s pozitivnim inotropnim učinkom ili presornih lijekova.
Bortezomib was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Bortezomib je bio primijenjen samo u 1. i 2.bloku zbog izbjegavanja mogućeg preklapanja toksičnosti s istodobno primijenjenim lijekovima u bloku 3.
The majority of the patients in both groups completed treatment, 80% in the BzmbR-CAP group and 82% in the R-CHOP group.
Većina bolesnika u obje skupine završilo je liječenje, 80 % u BzmbR-CAP skupini i 82 % u R-CHOP skupini.
Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Razmotriti povećanje doze na 1,0 mg/m2 ili daljnje smanjenje doze na 0,5 mg/m2 u sljedećim ciklusima na temelju bolesnikova podnošenja liječenja.
Ranbaxy Pharmacie Generiques 11-15, Quai de Dion Bouton 92800 Puteaux
11-15, Quai de Dion Bouton
The fraction of bortezomib bound to plasma proteins was not concentration-dependent.
Udio bortezomiba vezanog za proteine plazme nije ovisio o koncentraciji.
Male and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Muškarci i žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i do 3 mjeseca nakon liječenja.
Patients with pre-existing severe neuropathy may be treated with Bortezomib SUN only after careful risk/benefit assessment.
Bolesnici s već prisutnom teškom neuropatijom mogu se liječiti Bortezomib SUN-om nakon pomne procjene omjera rizika i koristi.
No new safety concerns were observed when bortezomib was added to the standard paediatric pre B cell ALL chemotherapy backbone.
Nisu zabilježena nova sigurnosna pitanja kada je bortezomib bio dodan standardnoj osnovnoj pedijatrijskoj kemoterapiji za pre-B-staničnu ALL.
A statistically significant benefit (p < 0.001) in favour of the BzmbR-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).
Statistički značajna korist (p < 0,001) za BzmbR-CAP liječenu skupinu u odnosu na R-CHOP skupinu bila je zapažena za TTP (medijan 30,5 naspram 16,1 mjesec), TNT (medijan 44,5 naspram 24,8 mjeseci) i TFI (medijan 40,6 naspram 20,5 mjeseci).
> 3 x ULN
> 3 x GGN
It is not necessary to protect the reconstituted medicinal product from light.
Rekonstituiranu otopinu lijeka nije neophodno zaštititi od svjetlosti.
Bortezomib was not genotoxic when tested in the in vitro mutagenicity assay (Ames assay) and in vivo micronucleus assay in mice.
Bortezomib nije bio genotoksičan kad se ispitivao in vitro mutagenim testom (Amesov test) i in vivo mikronukleusnim ispitivanjem u miševa.
Uncommon side effects (may affect up to 1 in 100 people) - hepatitis - severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing,
Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) - hepatitis - teška alergijska reakcija (anafilaktička reakcija) znakovi koji mogu uključiti otežano disanje,
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
It is, therefore, likely that bortezomib could have a potential effect on either male or female fertility.
Stoga postoji velika vjerojatnost da bi bortezomib mogao utjecati na plodnost kako u mužjaka, tako i u ženke.
For patients with a response first documented at cycle 6, two additional treatment cycles were given.
Bolesnicima za koje je odgovor na liječenje prvi put zabilježen u 6. ciklusu, primijenjena su dva dodatna ciklusa liječenja.
Inhibition of the proteasome results in cell cycle arrest and apoptosis.
Inhibicija proteasoma rezultira zastojem staničnog ciklusa i apoptozom.
Caution should be exercised when bortezomib is combined with CYP3A4 or CYP2C19 substrates (see section 4.5).
Potreban je oprez kad se bortezomib kombinira sa supstratima enzima CYP3A4 ili CYP2C19 (vidjeti dio 4.5).
There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving bortezomib (see section 4.8).
U rijetkim slučajevima prijavljena je akutna difuzna infiltrativna bolest pluća nepoznate etiologije, kao što je pneumonitis, intersticijska pneumonija, infiltracija pluća i akutni respiratorni distres sindrom (ARDS) u bolesnika koji su primali bortezomib (vidjeti dio 4.8).
Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Nakon intravenske bolusne ili supkutane injekcije u dozi od 1,3 mg/m2 primijenjene bolesnicima s multiplim mijelomom (n=14 u intravenskoj skupini, n=17 u supkutanoj skupini), ukupna sistemska izloženost nakon primjene ponovljenih doza (AUCtrajanja) bila je jednaka za supkutane i intravenske primjene.
A statistically significant survival benefit in favour of the Bzmb+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Primijećeno je statistički značajno veće preživljenje u skupini liječenoj s Bzmb+M+P (HR=0,695; p=0,00043) usprkos naknadnim terapijama koje uključuju liječenje bortezomibom.
Median
Medijana
In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m2 weekly and 1.3 mg/m2 twice-weekly.
U eksplorativnoj analizi djelotvornosti, stopa odgovora od 67,3 % (uključujući CR stopu od 28,6 %) prema mjerenju hematološkog odgovora (M-protein) bila je zabilježena u 49 procijenjenih bolesnika liječenih maksimalnim dopuštenim dozama od 1,6 mg/m2 na tjedan i 1,3 mg/m2 dvaput na tjedan.
This suggests that bortezomib distributes widely to peripheral tissues.
Ovi podaci ukazuju da se bortezomib znatno distribuira u periferna tkiva.
Orthostatic/postural hypotension was not acutely related to bolus infusion of bortezomib.
Ortostatska/posturalna hipotenzija nije bila akutno povezana s bolus infuzijom bortezomiba.
In patients, overdose more than twice the recommended dose has been associated with the acute onset of symptomatic hypotension and thrombocytopenia with fatal outcomes.
U bolesnika je predoziranje dozom koja je više od dvostruko veća od preporučene bilo povezano s akutnim početkom simptomatske hipotenzije i trombocitopenije sa smrtnim ishodima.
Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Gastrointestinalna toksičnost, uključujući mučninu, proljev, povraćanje i zatvor, vrlo su česti kod liječenja bortezomibom.
Bortezomib SUN might cause tiredness, dizziness, fainting, or blurred vision.
Bortezomib SUN može uzrokovati umor, omaglicu, nesvjesticu ili zamagljen vid.
Patients with mild hepatic impairment do not require a dose adjustment and should be treated per the recommended dose.
Bolesnicima s blagim oštećenjem jetre prilagodba doze nije potrebna i treba ih liječiti preporučenim dozama.
Day 1, 2, 3, 4 Day 8, 9, 10, 11
Dan 1, 2, 3, 4 Dan 8, 9, 10, 11
In the BzmbR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
U BzmbR-CAP skupini, 22,5 % bolesnika primilo je transfuzije trombocita u usporedbi s 2,9 % bolesnika u R-CHOP skupini.
Seizures have been uncommonly reported in patients without previous history of seizures or epilepsy.
Epileptički napadaji su manje često prijavljeni u bolesnika bez prethodnih epileptičkih napadaja ili epilepsije u anamnezi.
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.
U vrijeme unaprijed planirane privremene analize postigla se primarna mjera ishoda, vrijeme do progresije te je bolesnicima u M+P kraku studije bilo ponuđeno liječenje Bzmb+M+P.
This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p < 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
Ova prijevremena analiza je pokazala redukciju TTP rizika za 45 % (95 % CI; 29 - 57 %, p < 0,0001) za bolesnike koji su liječeni kombinacijskom terapijom bortezomiba i pegiliranog liposomalnog doksorubicina.
Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib SUN
Nehematološke toksičnosti stupnja ≥ 3 za koje se smatra da su povezane s Bortezomib SUN-om
Patients were administered intravenous doses of 0.7 to 1.3 mg/m2 of bortezomib twice weekly.
Bolesnicima su bile primijenjene intravenske doze od 0,7 do 1,3 mg/m2 bortezomiba dvaput tjedno.
Developmental toxicity studies in the rat and rabbit have shown embryo-fetal lethality at maternally toxic doses, but no direct embryo-foetal toxicity below maternally toxic doses.
Ispitivanja razvojne toksičnosti u štakora i kunića pokazala su embrio-fetalne letalne učinke pri dozama toksičnima za majku, ali nije bilo izravne embrio-fetalne toksičnosti u dozama nižim od onih toksičnih za majku.
Previously untreated multiple myeloma
Prethodno neliječeni multipli mijelom
Response rate populatione n=668
Stopa odgovora populacijae n=668
Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median hemoglobin of 105 g/l, and a median platelet count of 221.5 x 109/l.
Bolesnici su imali mijelom IgG/IgA/lakih lanaca u 63 %/25 %/8 % slučajeva, medijan hemoglobina od 105 g/l, i medijan broja trombocita od 221,5 x 109/l.
Anaphylactic shock, Amyloidosis, Type III immune complex mediated reaction
Anafilaktički šok, amiloidoza, reakcija tipa III posredovana imunokompleksima
Additional adverse drug reactions identified associated with the use of the combination therapy (BzmbR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Dodatne identificirane nuspojave povezane s primjenom kombiniranog liječenja (BzmbR-CAP) bile su infekcija hepatitisom B (< 1 %) i ishemija miokarda (1,3 %).
The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
Primarni ishod djelotvornosti ispitivanja bio je post-indukcijska stopa odgovora (CR+nCR).
Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatnu tvar, na bor ili neku od pomoćnih tvari navedenih u dijelu 6.1.
• 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.
U svakoj zemlji članici, nositelj odobrenja će s nacionalnim nadležnim tijelom dogovoriti sadržaj i oblik edukacijskog materijala.
The concentration of the resulting solution will be 2.5 mg/ml.
Koncentracija dobivene otopine bit će 2,5 mg/ml.
Median survival for the Bzmb+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Medijan preživljenja za skupinu koja je primala Bzmb+M+P bio je 56,4 mjeseci u odnosu na 43,1 za skupinu koja je primala M+P.
Grade 1 with pain or Grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
1. stupanj s bolovima ili 2. stupanj (umjereni simptomi; ograničavaju instrumentalne aktivnosti svakodnevnog života (ADL od engl.
Over a bortezomib concentration range of 0.01 to 1.0 μg/ml, the in vitro protein binding averaged 82.9% in human plasma.
U rasponu koncentracije bortezomiba od 0,01 do 1,0 μg/ml, vezanje za proteine ljudske plazme in vitro u prosjeku je iznosilo 82,9 %.
Six Bortezomib SUN cycles are recommended, although for patients with a response first documented at cycle 6, two additional Bortezomib SUN cycles may be given.
Preporučuje se šest ciklusa liječenja Bortezomib SUN-om, iako se bolesnicima za koje je odgovor prvi put zabilježen u 6. ciklusu mogu dati dva dodatna ciklusa liječenja Bortezomib SUNom.