natgillin/translations-raw huggingface dataset:
The usual starting dose of bortezomib is 1.3 mg/m body surface area twice a week.
Običajni začetni odmerek bortezomiba je 1,3 mg/m telesne površine dvakrat na teden.
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 4.4).
V primeru prevelikega odmerka bortezomiba je treba spremljati bolnikove vitalne znake in uvesti ustrezne podporne ukrepe za vzdrževanje krvnega tlaka (npr.: tekočine, učinkovine, ki zvišujejo krvni tlak, in/ali inotropne učinkovine) in telesne temperature (glejte poglavji 4.2 in 4.4).
Bortezomib should not be given by other routes.
Bortezomiba se ne sme dajati po nobeni drugi poti.
These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m and included in table 7.
Ti neželeni učinki so navedeni na podlagi celotnega nabora podatkov 5.476 bolnikov, od katerih je bilo 3.996 bolnikov zdravljenih z bortezomibom z odmerkom 1,3 mg/m telesne površine in so vključeni v preglednico 7.
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 MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease.
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, 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.
Overall complete response (CR+CRu)
Celokupen popolni odgovor (CR+CRu)
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 trdne rezultate za subkutano on intravensko uporabo (preglednica 15).
A hazard ratio < 1 indicates an advantage for BR-CAP.
Razmerje obetov (odds ratio-OR) > 1 predstavlja prednost za skupino BR-CAP.
Instructions for reconstitution Bortezomib must be reconstituted by a healthcare professional.
Navodila za rekonstitucijo raztopine Bortezomib mora rekonstituirati zdravstveno osebje.
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 nevropatija ≥ 3. stopnje se je pojavila pri 6 % bolnikov v skupini s subkutanim dajanjem v primerjavi s 16 % bolnikov v skupini, ki je prejemala zdravilo intravensko (p = 0,0264).
Efficacy results are presented in table 16:
Rezultati učinkovitosti so podani v preglednici 16:
For subcutaneous or intravenous use after reconstitution For single use.
Samo za subkutano ali intravensko uporabo po rekonstituciji.
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. ciklu še znižuje, lahko z zdravljenjem nadaljujejo, dokler zdravljenje dobro prenašajo in se odzivajo nanj.
Do not use bortezomib - 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.
Ne uporabljajte bortezomiba - če ste alergični na bortezomib, bor ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Bortezomib mediated proteasome inhibition affects cancer cells in a number of ways, including, but not limited to, altering regulatory proteins, which control cell cycle progression and nuclear factor kappa B (NF-kB) activation.
Zaviranje proteasoma z bortezomibom vpliva na rakave celice na več načinov, vključno s spremembo regulatornih proteinov, ki nadzorujejo napredovanje celičnega cikla in aktivacijo nuklearnega faktorja kappa B (NF-kB).
In particular, tell your doctor if you are using medicines containing any of the following active substances: - ketoconazole, used to treat fungal infections - ritonavir, used to treat HIV infection - rifampicin, an antibiotic used to treat bacterial infections - carbamazepine, phenytoin or phenobarbital used to treat epilepsy - St. John's Wort (Hypericum perforatum), used for depression or other conditions - oral antidiabetics
Še posebno morate svojega zdravnika obvestiti, če jemljete zdravila, ki vsebujejo katero izmed naslednjih učinkovin: - ketokonazol, ki se uporablja za zdravljenje glivičnih okužb - ritonavir, ki se uporablja za zdravljenje okužbe z virusom HIV - rifampicin, antibiotik, ki se uporablja za zdravljenje bakterijskih okužb - karbamazepin, fenitoin ali fenobarbital, ki se uporabljajo za zdravljenje epilepsije - šentjanževko (Hypericum perforatum), ki se uporablja pri depresiji ali drugih stanjih - peroralne antidiabetike
- If, after bortezomib has been held, the toxicity does not resolve, as defined above, then bortezomib must be discontinued.
• Če po prekinitvi zdravljenja z bortezomibom toksičnost ne mine kot je opisano zgoraj, je treba zdravljenje z bortezomibom ukiniti.
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 velikega tveganja.
Grade 2 with pain or grade 3 (severe symptoms; limiting self care ADL***)
Stopnja 2 z bolečino ali stopnja 3 (hudi simptomi; omejene fizične ADL***)
It is recommended that patients with at least partial response receive 2 additional cycles.
Priporočamo, da bolniki z najmanj delnim odgovorom prejmejo 2 dodatna cikla zdravljenja.
A statistically significant benefit (p < 0.001) in favour of the BR-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 BR-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).
1 year survival, % [95% CI]
1-letno preživetje,% [95 % CI]
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 10
Bolniki so imeli plazmocitom IgG/IgA/lahke verige v 63 %/25 %/8 %, mediano koncentracijo hemoglobina 105 g/l in mediano število trombocitov 221,5 x 10
Median survival for the B+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Mediana preživetja v skupini B+M+P je bila 56,4 mesecev, v skupini M+P pa 43,1 mesecev.
The incidence of peripheral neuropathy increases early in the treatment and has been observed to peak during cycle 5.
Incidenca periferne nevropatije se poveča v začetku zdravljenja in doseže najvišjo vrednost v 5. ciklu zdravljenja.
Additional adverse drug reactions identified associated with the use of the combination therapy (BR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Dodatno ugotovljena neželena učinka, povezana z uporabo kombiniranega zdravljenja (BR-CAP), sta bila okužba z virusom hepatitisa B (< 1%) in ishemija miokarda (1,3 %).
This 21-day period (3 weeks) corresponds to one treatment cycle.
To 21-dnevno obdobje (3 tedne) je en cikel zdravljenja.
Higher incidences were also noted for infections with grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
Večja je bila tudi pojavnost okužb z nevtropenijo stopnje ≥ 3(24 % proti 19 % v 1. sklopu in 22 % proti 11 % v 2.sklopu), povečane koncentracije ALT (17 % proti 8 % v 2. sklopu), hipokaliemije (18 % proti 6 % v 1. sklopu in 21 % proti 12 % v 2. sklopu) in hiponatriemije (12 % proti 5 % v 1. sklopu in 4 % proti 0 v 2. sklopu).
There is no known specific antidote for bortezomib overdose.
Specifični antidot za preveliko odmerjanje bortezomiba ni znan.
The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Analiza je dokazala izboljšan ORR (CR+PR) (razmerje obetov 3,769; 95 % CI 2,045-6,947; p < 0,001), PFS (stopnja tveganja 0,511; 95% CI 0,309-0,845; p = 0,008), TTP (stopnja tveganja 0,385; 95% CI 0,212-0,698; p = 0,001) pri zdravljenju z bortezomibom v kombinaciji z deksametazonom v primerjavi z zdravljenjem z bortezomibom v monoterapiji.
Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m 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 večji od priporočenega kliničnega odmerka (v mg/m in povišanjem srčne frekvence, zmanjšanjem kontraktilnosti srca, hipotenzijo in smrtjo.
Regardless of β2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the bortezomib arm.
Ne glede na koncentracijo β2-micikllobulina ob začetku zdravljenja, so se tudi vsi parametri učinkovitosti (čas do napredovanja bolezni in celokupno preživetje, kot tudi odziv na zdravljenje) v delu preskušanja z bortezomibom statistično značilno izboljšali.
• 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 plus dexamethasone, and bortezomib plus dexamethasone and thalidomide).
• Navodila za predpisovanje in uporabo, vključno z dolžino in številom ciklov zdravljenja z namenom zmanjševanja tveganja napak pri izdajanju in uporabi zdravila, ki bi jih lahko povzročile različne kombinacije režima uvajanja bortezomiba pred transplantacijo (bortezomib v kombinaciji z deksametazonom in bortezomib v kombinaciji z deksametazonom in talidomidom).
The duration of overall response was 21.4 months longer in the BR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Trajanje celokupnega odgovora je bilo 21,4 mesecev daljše v skupini BR-CAP (mediana 36,5 mesecev proti 15,1 meseca v skupini R-CHOP).
Overall survival* Events (deaths) n (%) Median a
Celokupno preživetje* dogodki (smrti) n (%) Mediana a
The overall best response rate (CR+PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1,
Pri 130 bolnikih je bila celokupna stopnja odgovora (CR+PR) 38,5 % (95% CI: 30,1;
The following medicinal products are given on day 1 of each bortezomib 21-day treatment cycle as intravenous infusions:
Naslednja zdravila boste prejeli 1. dan vsakega 21-dnevnega cikla zdravljenja z bortezomibom v obliki intravenske infuzije:
In patients aged ≥ 75 years, both regimens, BR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Bolniki, stari ≥ 75 let so oba režima zdravljenja, BR-CAP in R-CHOP, slabše prenašali (glejte poglavje 4.8).
Other medicines and bortezomib Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katero koli drugo zdravilo.
The overall incidence of hepatitis B infections was similar in patients treated with BR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Celokupna pogostnost okužbe z virusom hepatitisa B je bila podobna pri bolnikih, zdravljenih z BR-CAP ali s R-CHOP (0,8 % v primerjavi z 1,2 %).
The solution should be injected subcutaneously, at 45-90° angle.
Raztopino morate injicirati subkutano, pod kotom 45-90 °.
Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib.
Bolniki, pri katerih se pojavi ortostatska hipotenzija ob bortezomibu (intravensko), niso imeli nobenih znakov ortostatske hipotenzije pred zdravljenjem z bortezomibom.
Response rate population e n=668
Stopnja odziva populacijae n = 668
(95% CI) p-value c
(95% CI) p-vrednost c
Patients who did not obtain an optimal response (less than Complete Response [CR]) to therapy with bortezomib alone after 4 cycles were allowed to receive dexamethasone 20 mg daily on the day of and after bortezomib administration.
Bolniki, ki niso dosegli optimalnega odgovora (manj kot popolni odgovor [CR]) na zdravljenje z bortezomibom v monoterapiji po 4 ciklih zdravljenja, so prejeli 20 mg deksametazona na dan brez zdravila in po dajanju bortezomiba.
Undesirable effects in table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Za neželene učinke, navedene v preglednici 7, so raziskovalci menili, da imajo vsaj možno do verjetno vzročno povezavo z bortezomibom.
Table 8: Adverse reactions in patients with mantle cell lymphoma treated with BR-CAP in a clinical trial
Preglednica 8: Neželeni učinki pri bolnikih z limfomom plaščnih celic, zdravljenih z BR-CAP v kliničnih preskušanjih
• Infection or inflammation of the stomach and intestine
• okužba ali vnetje trebuha in črevesja
Your doctor will work out your dose of bortezomib according to your height and weight (body surface area).
Zdravnik bo določil odmerek na osnovi vaše telesne višine in mase (telesne površine).
The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
Primarna ocena učinkovitosti je bila stopnja odziva po uvedbi (CR+nCR).
Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Razvrstitev po 4. različici enotnih meril toksičnosti za vrednotenje neželenih učinkov Nacionalnega onkološkega inštituta (NCI Common Toxicity Criteria CTCAE v 4.0).
Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region.
Ocena razmerja tveganja na osnovi Coxovega proporcionalnega modela, prilagojena na osnovi stratifikacijskih dejavnikov: β2-micikllobulin, albumin in regija.
A statistically significant survival benefit in favour of the B+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Pri bolnikih v skupini B+M+P so opazili statistično značilno izboljšanje preživetja (HR (Hazard Ratio - razmerje tveganja) = 0,695; p = 0,00043), kljub kasnejšim terapijam, vključno s terapijo z 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).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z bortezomibom za vse skupine pediatrične populacije za indikacijo diseminirani plazmocitom in limfom plaščnih celic (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
Bortezomib therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL.
Zdravljenje z bortezomibom je treba prekiniti za največ 2 tedna, dokler nima bolnik ANC ≥ 750 celic/μl in število trombocitov ≥ 25.000 celic/μl.
Bortezomib is for single use only.
Bortezomib je samo za enkratno uporabo.
If you have mantle cell lymphoma and are given the medicine rituximab with bortezomib you must tell your doctor:
Če imate limfom plaščnih celic in prejemate rituksimab skupaj z bortezomibom, zdravniku povejte če:
Withhold bortezomib treatment until symptoms of toxicity have resolved.
prekinite zdravljenje z bortezomibom, dokler ne minejo znaki toksičnosti.
Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy BR-CAP (N=240)
Preglednica 10: Pojavnost periferne nevropatije v študiji LYM-3002 glede na stopnjo toksičnosti in prekinitev zdravljenja zaradi periferne nevropatije BR-CAP (n = 240)
Melphalan (9 mg/m 2) and prednisone (60 mg/m 2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Melfalan (9 mg/m2) in prednizon (60 mg/m2) se dajeta peroralno na 1., 2., 3., in 4. dan prvega tedna vsakega cikla zdravljenja.
For these dose cohorts, the combined 1-year survival rate was 88.1%.
Skupna stopnja 1-letnega preživetja za skupini bolnikov, ki sta prejemali ta dva odmerka, je bila 88,1 %.
TTP, days [95% CI]
TTP,dnevi ([95 % CI])
(95% CI) p-value c a Kaplan-Meier estimate b
(95% CI) p-vrednost c a Ocena po metodi Kaplan-Meier.
Uncommon Autonomic nervous system imbalance
Občasni neravnovesje v delovanju avtonomnega živčevja
Progressive multifocal leukoencephalopathy (PML) Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with bortezomib.
Progresivna multifokalna levkoencefalopatija (PML) Pri bolnikih, zdravljenih z bortezomibom, so poročali o zelo redkih primerih okužbe z JC virusom (John Cunningham virus), z neznano vzročno povezavo, ki je vodila v PML in smrt.
- Flush the peripheral or intravenous catheter with sterile, sodium chloride 9 mg/ml (0.9%) solution.
• Izperite periferni ali intravenski kateter s sterilno raztopino 9 mg/ml (0,9 %) natrijevega klorida.
Patients with previously treated light-chain (AL) Amyloidosis An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of bortezomib in patients with previously treated light-chain (AL) Amyloidosis.
Bolniki, s predhodno zdravljeno amiloidozo lahkih verig (AL amiloidoza) V odprti, ne-randomizirani študiji faze I/II so ugotavljali varnost in učinkovitost bortezomiba pri bolnikih, s predhodno zdravljeno AL amiloidozo.
1 mg/m to 0.7 mg/m
1 mg/m na 0,7 mg/m
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
Haematological toxicity - ≥ Grade 3 neutropenia with fever, grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
• nevtropenija z zvečano telesno temperaturo stopnje ≥ 3, nevtropenija 4. stopnje, ki traja več kot 7 dni, število trombocitov < 10.000 celic/μl
You might receive up to 8 cycles (24 weeks).
Lahko boste prejeli do največ 8 ciklov zdravljenja (24 tednov).
The following adverse reactions (grade ≥ 3) were observed at a higher incidence in the bortezomib containing treatment regimen as compared with a historical control study in which the backbone regimen was given alone: in Block 1 peripheral sensory neuropathy (3% versus 0%); ileus (2.1% versus 0%); hypoxia (8% versus 2%).
V shemi zdravljenja z dodanim bortezomibom so se naslednji neželeni učinki (stopnje ≥ 3) pojavili pogosteje kot v predhodni kontrolni študiji, kjer so bolniki prejemali samo osnovno shemo zdravljenja: v 1. sklopu periferna senzorična nevropatija (3 % proti 0 %), ileus (2,1 % proti 0 %), hipoksija (8 % proti 2 %).
h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
h Vključuje vse radiološke diagnostične metode CR+CRu+PR po IRC, ne glede na preverjanje kostnega mozga in
The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BR-CAP group and 5.0% in the R-CHOP group) as well as grade 3 and higher bleeding events (BR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]).
V obeh skupinah pa je bila podobna celokupna pojavnost krvavitev vseh stopenj (6,3 % v BR-CAP in 5,0 % v R-CHOP) in krvavitev stopnje 3 ali več (BR-CAP: 4 bolniki [1,7 %]; R-CHOP: 3
- Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
• Raztopino injicirajte v obliki 3-5 sekund trajajoče bolusne intravenske injekcije skozi periferno ali centralno intravensko cevko v veno.
(95% CI)=1.688
(95% CI) = 1,688 p-vrednost g
M (9 mg/m P (60 mg/m
M (9 mg/m P (60 mg/m dan dan dan dan
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Pri bolnikih z MCL (študija LYM-3002) je bila pojavnost okužbe z virusom herpes zoster v skupini BR-CAP 6,7 % in v skupini R-CHOP 1,2 % (glejte poglavje 4.8).
In addition, the incidence of grade 3 or higher peripheral neuropathies was 10% lower, and the discontinuation rate due to peripheral neuropathies 8% lower for the subcutaneous group as compared to the intravenous group.
Dodatno je bila pri subkutani skupini incidenca perifernih nevropatij stopnje 3 ali več za 10 % manjša in za 8 % manjša pogostnost prekinitve zdravljenja zaradi perifernih nevropatij, v primerjavi s skupino, ki je zdravilo prejemala intravensko.
Pregnancy and breast-feeding You must not use this medicine if you are pregnant, unless clearly necessary.
Nosečnost in dojenje Če ste noseči zdravila Bortezomib Fresenius Kabi ne smete prejeti, razen, če je nujno potrebno.
One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BTDx and TDx groups, respectively.
Eno avtologno presaditev krvotvornih matičnih celic so opravili pri 105 (81%) bolnikih v skupini BTDx in 78 (61%) bolnikih v skupini TDx.
The incidence of all grade peripheral neuropathy with bortezomib administered intravenously was lower in the historical studies with bortezomib administered intravenously than in study MMY-3021.
Pogostnost vseh stopenj periferne nevropatije pri dajanju bortezomiba intravensko je bila v že prej opravljenih študijah manjša kot v študiji MMY-3021.
Once the symptoms of the toxicity have resolved, bortezomib treatment may be re-initiated at a 25% reduced dose (1.3 mg/m reduced to 1.0 mg/m 2; 1.0 mg/m reduced to 0.7 mg/m 2).
Ko znaki toksičnosti minejo, lahko zdravljenje z bortezomibom ponovno uvedete, vendar s 25 % manjšim odmerkom (1,3 mg/m zmanjšano na 1,0 mg/m 2; 1,0 mg/m zmanjšano na 0,7 mg/m telesne površine).
(CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
59 ml/min/1,73 m 2, n = 10), zmerna okvara ledvic (CrCL = 20-39 ml/min/1,73 m 2, n = 9), resna okvara ledvic (CrCL < 20 ml/min/1,73 m2, n = 3).
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.
The incidence of herpes zoster among patients in the BR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Pogostnost virusa herpes zoster v skupini BR-CAP je bila 10,7 % pri bolnikih, ki niso prejemali protivirusnih zdravil, pri bolnikih, ki so prejemali protivirusna zdravila pa 3,6 % (glejte poglavje 4.4).