natgillin/translations-raw huggingface dataset:
Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib bortezomib intravenous arm bortezomib subcutaneous arm
Preglednica 15: Povzetek analize učinkovitosti subkutanega in intravenskega dajanja bortezomiba bortezomib intravensko bortezomib subkutano
Bortezomib Accord should not be given by other routes.
Zdravilo Bortezomib Accord se ne sme dajati po nobeni drugi poti.
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.
Neglede na koncentracijo β2- mikroglobulina 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.
What you need to know before you use Bortezomib Accord Do not use Bortezomib Accord
Kaj morate vedeti, preden boste uporabili zdravilo Bortezomib Accord Ne uporabljajte zdravila Bortezomib Accord
tiredness, confusion, blindness or other vision problems.
zmedenostjo, slepoto in drugimi težavami z vidom.
Geometric mean (%CV) clearance was 7.79 (25%) L/hr/m2, volume of distribution at steady-state was 834 (39%) L/m2, and the elimination half-life was 100 (44%) hours.
Geometrični povprečni očistek (%CV) je bil 7,79 l/h/m2 (25 %), volumen porazdelitve v dinamičnem ravnovesju 834 l/m2 (39 %), razpolovni čas izločanja pa 100 ur (44 %).
Fall, Contusion
Občasni padci, kontuzije
ORR (CR+PR) p-valuea
ORR (CR+PR) p-vrednosta
Very Common Musculoskeletal pain* Common
Zelo pogosti mišično-skeletna bolečina*
Additional adverse drug reactions identified associated with the use of the combination therapy (BzR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Dodatno ugotovljena neželena učinka, povezana z uporabo kombiniranega zdravljenja (BzR-CAP), sta bila okužba z virusom hepatitisa B (< 1%) in ishemija miokarda (1,3%).
Instructions for reconstitution Bortezomib Accord must be reconstituted by a healthcare professional.
Navodila za rekonstitucijo raztopine Zdravilo Bortezomib Accord mora rekonstuirati zdravstveno osebje.
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.
Vmesna analiza je pokazala zmanjšanje tveganja za TTP za 45% (95% CI; od 29 do 57%, p < 0,0001) pri bolnikih, ki so prejemali kombinirano terapijo z bortezomibom in pegiliranim liposomskim doksorubicinom.
The following medicinal products are given on day 1 of each Bortezomib Accord 21-day treatment cycle as intravenous infusions:
Naslednja zdravila boste prejeli 1. dan vsakega 21-dnevnega kroga zdravljenja z zdravilom Bortezomib Accord v obliki intravenske infuzije:
Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention programme are met.
Uporaba talidomida je med nosečnostjo in pri ženskah v rodni dobi kontraindicirana, razen če so doseženi vsi pogoji programa preprečevanja nosečnosti za talidomid (Thalidomide
In patients aged ≥ 75 years, both regimens, BzR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Bolniki, stari ≥ 75 let so oba režima zdravljenja, BzR-CAP in R-CHOP, slabše prenašali (glejte poglavje 4.8).
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 bortezomib intravensko (p=0,0264).
Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1.
Preobčutljivost na zdravilno učinkovino, bor ali katero koli pomožno snov, navedeno v poglavju 6.1.
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 krogih zdravljenja, so prejeli 20 mg deksametazona na dan brez zdravila in po dajanju bortezomiba.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določenev seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
Male patients and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Bolniki in bolnice v rodni dobi morajo uporabljati ustrezno kontracepcijsko metodo med in še 3 mesece po zdravljenju.
The overall incidence of hepatitis B infections was similar in patients treated with BzR-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 BzR-CAP ali s R-CHOP (0,8% v primerjavi z 1,2%).
HRb (95% CI)=0.63 (0.50; 0.79) p-valued < 0.001
HRb (95% CI)=0,63 (0,50; 0,79) p-vrednostd < 0,001
Hepatitis B virus (HBV) reactivation and infection
Reaktivacija in okužba z virusom hepatitisa B (HBV)
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
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%
Contents of the pack and other information What Bortezomib Accord contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Bortezomib Accord
1.3 The reconstituted product is preservative free and should be used immediately after preparation.
Rekonstituirana raztopina ne vsebuje konzervansov in ga je treba porabiti takoj po raztapljanju.
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 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).
Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Cushingov sindrom*, hipertiroidizem*, motnje izločanja antidiuretičnega hormona
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% IZ 2,045-6,947; p < 0,001), PFS (stopnja tveganja 0,511; 95% IZ 0,309-0,845; p=0,008), TTP (stopnja tveganja 0,385; 95% IZ 0,212-0,698; p=0,001) pri zdravljenju z bortezomibom v kombinaciji z deksametazonom v primerjavi z zdravljenjem z bortezomibom v monoterapiji.
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 < 1/10); občasni
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the reconstituted solution should be used immediately after preparation.
Z mikrobiološkega vidika je treba rekonstituirano zdravilo uporabiti takoj, razen če metoda odpiranja/rekonstitucije/redčenja izključuje tveganje kontaminacije z mikrobi.
Cochran Mantel-Haenszel test. b Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in BzDx group and 52/242 [21%] in VDDx group).
b Nanaša se na stopnjo odgovora po drugi presaditvi pri posameznikih, pri katerih je bila le-ta izvedena (42/240 [18%] v skupini BzDx in 52/242 [21%] v skupini BzDx).
TTP, days [95% CI]
TTP dnevi ([95% CI])
Bortezomib Accord might cause tiredness, dizziness, fainting, or blurred vision.
Zdravilo Bortezomib Accord lahko povzroči utrujenost, omotičnost, omedlevico ali zamegljen vid.
Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median haemoglobin of 105 g/l, and a median platelet count of 221.5 x 109/l.
Bolniki so imeli plazmocitom IgG/IgA/lahke verige v 63 %/25 %/8 %, mediano koncentracijo hemoglobina 105 g/l in mediano število trombocitov 221,5 x109/l.
This includes any possible side effects not listed in this leaflet.
Posvetujte se tudi, če opazite katere koli možne neželene učinke, ki niso navedeni v tem navodilu.
The duration of overall response was 21.4 months longer in the BzR-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 BzR-CAP (mediana 36,5 mesecev proti 15,1 meseca v skupini R-CHOP).
The median duration of complete response was 42.1 months in the BzR-CAP group compared with 18 months in the R-CHOP group.
Mediana trajanja popolnega odgovora je bila 42,1 meseca v skupini BzR-CAP in 18 mesecev v skupini R-CHOP.
Although in patients aged ≥ 75 years, both BzR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzR-CAP groups was 68%, compared to 42% in the RCHOP group.
Čeprav so bolniki, stari ≥ 75 let, slabše prenašali oba režima zdravljenja, BzR-CAP in R-CHOP, je bila stopnja resnih neželenih učinkov v skupini BzR-CAP 68% v primerjavi z 42% v skupini R-CHOP.
ORe (95% CI)=1.428 (0.749; 2.722) p-value g=0.275
ORe (95% CI)=1,428 (0,749; 2,722) p-vrednostg=0,275
Table 8 Adverse reactions in patients with Mantle cell lymphoma treated with BzR-CAP in a clinical trial
Preglednica 8: Neželeni učinki pri bolnikih z limfomom plaščnih celic, zdravljenih z BzR-CAP v kliničnih preskušanjih
Bortezomib Accord must be reconstituted by a healthcare professional (see section 6.6).
Accord mora rekonstituirati zdravstveno osebje (glejte poglavje 6.6).
The usual starting dose of Bortezomib Accord is 1.3 mg/m2 body surface area twice a week.
Običajni začetni odmerek zdravila Bortezomib Accord je 1,3 mg/m2 telesne površine dvakrat na teden.
Melphalan (9 mg/m2) and prednisone (60 mg/m2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Melfalan (9 mg/m2) in prednizolon 60 mg/m2) se dajeta peroralno na 1., 2., 3., in 4. dan prvega tedna vsakega kroga zdravljenja.
If you have mantle cell lymphoma and are given the medicine rituximab with Bortezomib Accord you should tell your doctor:
Če imate limfom plaščnih celic in prejemate rituksimab skupaj z zdravilom Bortezomib Accord, zdravniku povejte če:
NA=not applicable, NE=not estimated
NOS (not otherwise specified) = ni drugače določeno
What Bortezomib Accord is and what it is used for
Kaj je zdravilo Bortezomib Accord in za kaj ga uporabljamo
CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-valued
CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-vrednostd
Absorption Following intravenous bolus administration of a 1.0 mg/m2 and 1.3 mg/m2 dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose maximum plasma concentrations of bortezomib were 57 and 112 ng/ml, respectively.
Absorpcija Po intravenski aplikaciji bolusnega odmerka 1,0 mg/m2 in 1,3 mg/m2 11 bolnikom z diseminiranim plazmocitomom in očistkom kreatinina večjim kot 50 ml/min, sta bili povprečni vrednosti najvišjih plazemskih koncentracij bortezomiba po prvem odmerku 57 in 112 ng/ml.
Dose adjustments during treatment and re-initiation of treatment for monotherapy
Prilagoditev odmerjanja med zdravljenjem in pri ponovni uvedbi zdravljenja v obliki monoterapije
Patients in the BzTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
V skupini BzTDx oziroma TDx je bila mediana starost bolnikov 57 let oziroma 56 let, 99% oziroma 98% je bilo belcev, moških je bilo 58% oziroma 54%.
Note: An OR > 1 indicates an advantage for Bz-containing induction therapy.
Opomba: OR > 1 kaže na prednost uvajalnega zdravljenja z Bz.
Bortezomib Accord therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Zdravljenje z zdravilom Bortezomib Accord je treba prekiniti dokler se simptomi toksičnosti ne povrnejo na 2. stopnjo ali še izboljšajo.
The other ingredient is mannitol (E421).
Pomožna snov je manitol (E421).
N=130 (ITT population)
n=130 (ITT populacija)
What Bortezomib Accord is and what it is used for What you need to know before you use Bortezomib Accord How to use Bortezomib Accord Possible side effects
Kaj je zdravilo Bortezomib Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Bortezomib Accord Kako uporabljati zdravilo Bortezomib Accord
Bortezomib Accord is for single use only.
Zdravilo Bortezomib Accord je samo za enkratno uporabo.
The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the Bortezomib Accord 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 %).
The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BzR-CAPgroup and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (BzR-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 BzR-CAP in 5,0 % v R-CHOP) in krvavitev stopnje 3 ali več (BzR-CAP: 4 bolniki [1,7 %]; R-CHOP: 3 bolniki [1.2 %]).
ORe (95% CI)=1.688 (1.148; 2.481) p-valueg=0.007
ORe (95% CI)=1,688 (1,148; 2,481) p-vrednostg=0,007
Dex n=336a Bz n=132a
Bz n=333a n=336a Bz n=132a
Once weekly Bortezomib Accord (cycles 5-9)
Odmerjanje zdravila Bortezomib Accord enkrat na teden (krogi 5-9)
EBMT criteria g All randomised patients with secretory disease * Survival update based on a median duration of follow-up at 60.1 months mo: months
CR = popolni odgovor; PR = delni odgovor, EBMT kriteriji g Vsi randomizirani bolniki s sekrecijsko boleznijo * preživetje na osnovi podatkov po 60,1 mesecih spremljanja CI = interval zaupanja
Orthostatic/postural hypotension was not acutely related to bolus infusion of bortezomib.
Ortostatska oz. posturalna hipotenzija ni bila akutno povezana z infuzijo bortezomiba.
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/m2 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
(usually on the legs) to large bruise-like patches under the skin or tissue
(najpogosteje na nogah) do velikimi, modricam podobnimi podkožnimi ali tkivnimi lisami • nerakave ciste
Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each Bortezomib Accord treatment cycle.
Melfalan in prednizolon je treba dati peroralno na 1., 2., 3. in 4. dan v prvem tednu vsakega kroga zdravljenja z zdravilom Bortezomib Accord.
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BzR-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 zosterv skupini BzR-CAP 6,7% in v skupini R-CHOP 1,2% (glejte poglavje 4.8).
N=127 (ITT population)
n=127 (ITT populacija)
Overall complete response (CR+CRu)f n(%)
Celokupen popolni odgovor (CR+CRu)f n(%)
* Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
* na osnovi prilagoditev odmerjanja v študijah faze II in III pri bolnikih z diseminiranim plazmocitomom in izkušenj v obdobju trženja.
Table 16: Efficacy results from study LYM-3002
Preglednica 15: Rezultati učinkovitosti zdravila v študiji LYM-3002 Učinkovitost
The incidence of herpes zoster among patients in the BzR-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 BzR-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).
Progression free survival (IRC)a Events n (%)
Preživetje brez napredovanja bolezni (IRC)a dogodki n (%)
Bortezomib Accord powder for solution for injection is a white to off-white cake or powder.
Bortezomib Accord je prašek za raztopino za injiciranje je bela do belkasta pogača ali prašek.
Reduce Bortezomib Accord to 1.0 mg/m2
zmanjšajte odmerek zdravila Bortezomib Accord na 1,0 mg/m2
Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BzR-CAP arm and with at least a possible or probable causal relationship to the components of the BzR-CAP arm, are listed in Table 8 below.
V preglednici 8 so navedeni ugotovljeni neželeni učinki s pogostnostjo ≥ 1%, ki je bila podobna ali večja v skupini BzR-CAP in z najmanj verjetno ali možno vzročno povezanostjo s komponentami v skupini BzR-CAP.
Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib Accord
Ne-hematološka toksičnost stopnje ≥ 3 povezana z uporabo zdravila Bortezomib Accord
Powder for solution for injection 3.5 mg/vial
prašek za raztopino za injiciranje 3,5 mg/vialo
* Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by
* primarna ocena učinkovitosti a OR za stopnje odziva na osnovi Mantel-Haenszelove ocene razmerja verjetnosti za stratificirane preglednice; p-vrednosti
In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours with daunorubicin and bortezomib for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
V kliničnem preskušanju, sta dva bolnika (od dveh), pri katerih so akutno mielogeno levkemijo zdravili z visokim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/m2 na dan) skupaj z daunorubicinom in bortezomibom, umrla zaradi SARS na začetku zdravljenja in študijo so zaključili.
Bortezomib treatment must be withheld at the onset of any ≥ Grade 3 bortezomib-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 haematological toxicities (see also section 4.4).
Zdravljenje z bortezomibom je treba prekiniti ob pojavu katere koli z uporabo z bortezomibom povezane ne-hematološke toksičnosti stopnje ≥ 3 (razen nevropatije) ali hematološke toksičnosti stopnje ≥ 3 (glejte tudi poglavje 4.4).
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).
Pri bolnikih, ki so prejemali bortezomib, so redko poročali o akutni difuzni infiltracijski pljučni bolezni neznane etiologije, kot je pneumonitis, intersticijska pljučnica, infiltracija pljuč in sindrom akutne respiratorne stiske (SARS) (glejte poglavje 4.8).
• Sensitivity to light
• izbuljene oči • občutljivost na svetlobo
• different reconstitution requirements for Bortezomib Accord 3.5 mg intravenous or subcutaneous use
• Različne zahteve za rekonstitucijo zdravila Bortezomib Accord 3,5 mg pri intravenski ali subkutani uporabi.
Other medicines and Bortezomib Accord
Druga zdravila in zdravilo Bortezomib Accord
Median PFS by investigator assessment was 30.7 months in the BzR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Mediana PFS po oceni raziskovalca je bila 30,7 mesecev v skupini BzR-CAP in 16,1 meseca v skupini R-CHOP (razmerje tveganja [HR]=0,51; p < 0,001).
In the BzR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
V skupini BzR-CAP je prejelo infuzijo trombocitov 22,5 % bolnikov, v skupini R-CHOP pa 2,9 % bolnikov.
Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone
Prilagajanje odmerka med zdravljenjem in ob ponovni uvedbi kombiniranega zdravljenja z melfalanom in prednizolonom
Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib.
pri katerih se pojavi ortostatska hipotenzija ob bortezomibu (intravensko), niso imeli nobenih znakov ortostatske hipotenzije pred zdravljenjem z bortezomibom.
For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics.
Za dodatne informacije o melfalanu in prednizolonu, glejte ustrezna Povzetka glavnih značilnosti zdravila.
• advice on how to reduce the risk of mix-up of intravenous and subcutaneous reconstituted syringes
• Navodilo kako lahko zmanjšamo možnost zamenjave injekcijskih brizg za intravensko in subkutano injiciranje.
Median OS was 90.7 months for the BzR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001).
V skupini BzR-CAP je bilo mediano OS 90,7 mesecev v primerjavi s 55,7 meseci v skupini R-CHOP (HR=0,66; p=0,001).
WESSLING Hungary Kft. Anonymus u. 6., Budapest, 1045, Hungary
WESSLING Hungary Kft. Anonymus u. 6., Budapest, 1045, Madžarska
In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with bortezomib+melphalan+prednisone compared with melphalan+prednisone (14% versus 4% respectively).
V študiji faze III, pri bolnikih s predhodno ne-zdravljenim diseminiranim plazmocitomom, je bila splošna pojavnost reaktivacije virusa herpes zoster pri bolnikih zdravljenih z bortezomibom+melfalanom+prednizonom pogostejša, kot pri bolnikih zdravljenih z melfalanom+prednizonom (14% v primerjavi s 4%).
When toxicity resolves re-initiate Bortezomib Accord treatment and reduce dose to 0.7 mg/m2 once per week.
Nato ponovno uvedite zdravljenje z zdravilom Bortezomib Accord in zmanjšajte odmerek na 0,7 mg/m2 enkrat na teden.
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 stopnjo bolezni.
Powder for solution for injection 1 mg/vial
prašek za raztopino za injiciranje 1 mg/vialo