natgillin/translations-raw huggingface dataset:
Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Razvrstitev po 2. različici enotnih meril toksičnosti za vrednotenje neželenih učinkov nacionalnega onkološkega inštituta (NCI Common Toxicity Criteria CTCAE v 4.0).
Haematological toxicity - ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μl
Toksični učinki na hematološki sistem - nevtropenija z zvečano telesno temperaturo stopnje ≥ 3, nevtropenija 4. stopnje, ki traja več kot 7 dni, število trombocitov < 10.000 celic/μl
Median
mediana
The concentration of the resulting solution will be 2.5 mg/ml.
Koncentracija dobljene raztopine je 2,5 mg/ml.
Incidence of death from “Progressive disease” was 18% in the subcutaneous group and 9% in the intravenous group.
Incidenca smrti zaradi napredovanja bolezni je bila v subkutani skupini 18 % in v intravenski skupini
Orthostatic/postural hypotension was not acutely related to bolus infusion of bortezomib.
Ortostatska oz. posturalna hipotenzija ni bila akutno povezana z bolusno infuzijo bortezomiba.
- If, after Bortezomib SUN has been held, the toxicity does not resolve, as defined above, then Bortezomib SUN must be discontinued.
- Če po prekinitvi zdravljenja z zdravilom Bortezomib SUN toksičnost ne mine, kot je opisano zgoraj, je treba zdravljenje z zdravilom Bortezomib SUN ukiniti.
In myeloma, bortezomib affects the ability of myeloma cells to interact with the bone marrow microenvironment.
Pri plazmocitomu bortezomib vpliva na sposobnost plazmocitomskih celic za interakcijo z mikrookoljem kostnega mozga.
• to remind that patients receiving Bortezomib SUN in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
• Bolnike, ki prejemajo zdravilo Bortezomib SUN v kombinaciji s talidomidom je treba opozoriti, da morajo upoštevati program preprečevanja nosečnosti kot je predpisan za talidomid, s sklicem na SmPC za talidomid za pridobitev dodatnih informacij.
Table 16: Efficacy results from study LYM-3002 Efficacy endpoint
Preglednica 16: Rezultati učinkovitosti zdravila v študiji LYM-3002 Učinkovitost
Bortezomib SUN should not be given by other routes.
Zdravilo Bortezomib SUN se ne sme dajati po nobeni drugi poti.
- a severe reversible brain condition which includes seizures, high blood pressure, headaches, tiredness, confusion, blindness or other vision problems.
- hudo reverzibilno stanje možganov s krči, visokim krvnim tlakom, glavoboli, utrujenostjo, zmedenestjo, slepoto in drugimi težavami z vidom.
Post-marketing adverse reactions not seen in clinical trials are also included.
Vključuje tudi neželene učinke v obdobju trženja, ki se v kliničnih študijah niso pojavili.
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 prednizon 60 mg/m2) se dajeta peroralno na 1., 2., 3., in 4. dan prvega tedna vsakega kroga zdravljenja.
• storage precautions for reconstituted solution
• Pogoje shranjevanja rekonstituirane raztopine.
Surgical and medical procedures
Kirurški in drugi medicinski posegi
The duration of overall response was 21.4 months longer in the BzmbR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Trajanje celokupnega odziva je bilo za 21,4 meseca daljše v skupini BzmbR-CAP (mediana 36,5 meseca proti 15,1 meseca v skupini R-CHOP).
Patients in the BzmbTDx 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 BzmbTDx oziroma TDx je bila mediana starost bolnikov 57 let oziroma 56 let, 99 % oziroma 98 % je bilo belcev, moških je bilo 58 % oziroma 54 %.
Following a review of post-marketing cases and literature reports for the period covered by this PSUR, 158 cases of “Lid, lash and lacrimal infections, irritations and inflammations” were retrieved in patients who received bortezomib.
Po pregledu primerov v obdobju trženja zdravila in poročil iz literature v obdobju, ki ga pokriva zadevni PSUR, so pri bolnikih, ki so prejemali bortezomib odkrili 158 primerov okužbe vek, trepalnic in lakrimalnih okužb, draženj in vnetij.
The major metabolic pathway is deboronation to form two deboronated metabolites that subsequently undergo hydroxylation to several metabolites.
Najpomembnejša pot presnove je odcepitev bora, pri čemer nastaneta dva presnovka, ki se nato hidroksilirata do številnih presnovkov.
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).
(p < 0,001) v skupini BzmbR-CAP v primerjavi s skupino R-CHOP za TTP (mediana 30,5 proti 16,1 meseca), TNT (mediana 44,5 proti 24,8 meseca) in TFI (mediana 40,6 proti 20,5 meseca).
Patients who had received 2 to 3 prior therapeutic regimens had a response rate of 32% (10/32) and patients who received greater than 7 prior therapeutic regimens had a response rate of 31% (21/67).
Bolniki, ki so prejeli 2 do 3 predhodne vrste zdravljenj, so imeli stopnjo odziva 32 % (10/32).
Cases of ileus have been uncommonly reported (see section 4.8).
Občasno so poročali o primerih zapore črevesja (glejte poglavje 4.8).
In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BzmbR-CAP arm and 61% of patients in the R-CHOP arm.
V študiji LYM-3002 je podporno zdravljenje s kolonije spodbujajočimi faktorji prejelo 78 % bolnikov v skupini BzmbR-CAP in 61 % bolnikov v skupini R-CHOP.
This medicine is for intravenous or subcutaneous use.
To zdravilo se uporablja intravensko ali subkutano.
Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy
Preglednica 10: Pojavnost periferne nevropatije v študiji LYM-3002 glede na stopnjo toksičnosti in prekinitev zdravljenja zaradi periferne nevropatije
Fertility Fertility studies were not conducted with bortezomib (see section 5.3).
Študije plodnosti pri uporabi bortezomiba niso bile izvedene (glejte poglavje 5.3).
- The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
- Rekonstituirano raztopino injiciramo subkutano v stegno (desno ali levo) ali trebuh (desno ali levo).
The solution should be injected subcutaneously, at a 45-90° angle.
Raztopino morate injicirati subkutano, pod kotom 45-90°.
The fraction of bortezomib bound to plasma proteins was not concentration-dependent.
Delež bortezomiba, vezanega na plazemske beljakovine, ni bil odvisen od koncentracije zdravila.
When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section).
Če jemljete talidomid, morate biti še posebej pozorni na zahteve po testiranju in preprečevanju nosečnosti (glejte poglavje Nosečnost in dojenje).
Animal studies to determine the effects of bortezomib on parturition and post-natal development were not conducted (see section 5.3).
Študije na živalih za ugotavljanje učinkov bortezomiba na porod in postnatalni razvoj niso bile opravljene (glejte poglavje 5.3).
Bortezomib SUN 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 zdravilom Bortezomib SUN je treba prekiniti za največ 2 tedna, dokler nima bolnik ANC ≥ 750 celic/μl in število trombocitov ≥ 25.000 celic/μl.
Table 12: Efficacy results from study IFM-2005-01 Endpoints
Preglednica 12: rezultati učinkovitosti študije IFM-2005-01 Ocena učinkovitosti
In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
Raziskave in vitro kažejo, da je bortezomib šibek zaviralec izoencimov citokroma P450 (CYP) 1A2, 2C9, 2C19, 2D6 in 3A4.
Therefore, patients who experience constipation should be closely monitored.
Zato je treba bolnike z zaprtostjo skrbno spremljati.
Most patients required treatment for their orthostatic hypotension.
Pri večini bolnikov so zdravili ortostatsko hipotenzijo.
The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BzmbR-CAP group and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (BzmbR-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 BzmbR-CAP in 5,0% v R-CHOP) in krvavitev stopnje 3 ali več (BzmbR-CAP: 4 bolniki [1,7%]; R-CHOP: 3 bolniki [1.2%]).
For patients with a response first documented at cycle 6, two additional treatment cycles were given.
Bolniki, ki so dosegli odziv šele v 6. krogu, so prejeli dva dodatna kroga zdravljenja.
Be sure that the correct dose is being given for the subcutaneous route of administration (2.5 mg/ml).
Preverite in zagotovite pravilni odmerek za subkutano dajanje zdravila (2,5 mg/ml).
There were 140 patients with ALL or LL enrolled and evaluated for safety; median age was 10 years (range 1 to 26).
Varnost so ocenjevali pri 140 vključenih bolnikih z ALL ali LL, z mediano starostjo 10 let (v razponu od 1 do 26).
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 zdravilom 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 usual starting dose of Bortezomib SUN is 1.3 mg/m2 body surface area twice a week.
Običajni začetni odmerek zdravila Bortezomib SUN je 1,3 mg/m2 telesne površine dvakrat na teden.
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, nerandomizirani študiji faze I/II so ugotavljali varnost in učinkovitost bortezomiba pri bolnikih s predhodno zdravljeno AL-amiloidozo.
* Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
* Na podlagi prilagoditev odmerjanja v študijah faze II in III pri bolnikih z diseminiranim plazmocitomom in izkušenj v obdobju trženja.
Once weekly Bortezomib SUN (cycles 5-9)
Odmerjanje zdravila Bortezomib SUN enkrat na teden (krogi 5-9)
There was no evidence of cumulative thrombocytopenia.
Znakov kumulativne trombocitopenije ni bilo.
The median duration of complete response was 42.1 months in the BzmbR-CAP group compared with 18 months in the R-CHOP group.
Mediana trajanja popolnega odziva je bila 42,1 meseca v skupini BzmbR-CAP in 18 mesecev v skupini R-CHOP.
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.
Kinetiko zaviranja proteasoma so ovrednotili in vitro in pri tem pokazali, da poteka disociacija bortezomiba s proteasoma z razpolovnim časom t½ = 20 minut, kar pomeni, da je zavora proteasoma, ki jo doseže bortezomib, povratna.
These effects have been observed in patients with multiple myeloma affected by an advanced osteolytic disease and treated with bortezomib.
Te učinke so opazili pri bolnikih z diseminiranim plazmocitomom z napredovalo osteolitično boleznijo, ki so prejemali bortezomib.
Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours is not recommended.
Zato ta režim dajanja s sočasnim velikim odmerkom citarabina v 24-urni kontinuirani infuziji (2 g/m2
Cochran Mantel-Haenszel test. b Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in BzmbDx 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 VcDx in 52/242 [21%] v skupini VDDx).
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.
Induction Transplant Regimens Graph shall contain the following key elements:
Diagram režima uvajanja pred transplantacijo mora vsebovati naslednje ključne elemente
What you need to know before you are given Bortezomib SUN You should NOT be given Bortezomib SUN - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine
Kaj morate vedeti, preden boste uporabili zdravilo Bortezomib SUN Ne uporabljajte zdravila Bortezomib SUN: - če ste alergični na bortezomib, bor ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
In patients with MCL, transient neutropenia that was reversible between cycles was observed, with no evidence of cumulative neutropenia.
Pri bolnikih z MCL so opažali prehodno nevtropenijo, ki je bila med krogi zdravljenja reverzibilna.
Patients on oral antidiabetic agents receiving bortezomib treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.
Pri bolnikih, ki so prejemali peroralne antidiabetike in bortezomib, je potrebno skrbno spremljanje koncentracije glukoze v krvi in prilagoditi odmerek antidiabetika.
Eighteen percent of patients achieved, or had an improved response [MR (11%) or PR (7%)] with combination treatment.
[MR (11 %) ali PR (7 %)] pri kombiniranem zdravljenju.
Hepatitis B Virus (HBV) reactivation and infection Mantle cell lymphoma
Reaktivacija in okužba z virusom hepatitisa B (HBV) Limfom plaščnih celic
Patients diagnosed with PML had prior or concurrent immunosuppressive therapy.
Bolniki s PML so že pred diagnozo prejemali ali sočasno prejemajo imunosupresivno zdravljenje.
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 posebej 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
Therefore, platelet counts should be monitored prior to each dose of bortezomib.
Zato je treba pred dajanjem vsakega odmerka bortezomiba določiti število trombocitov.
Inhibition of the proteasome results in cell cycle arrest and apoptosis.
Zavora proteasoma povzroči ustavitev celičnega ciklusa in apoptozo.
In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes indicate that bortezomib is primarily oxidatively metabolised via cytochrome P450 enzymes, 3A4, 2C19, and 1A2.
In vitro študije na človeških jetrnih mikrosomih in izocimih citokroma P450 z izraženo človeško cDNA kažejo, da se bortezomib v prvi vrsti oksidativno presnovi z encimi citokroma P450, 3A4, 2C19 in 1A2.
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 nižja kot v študiji MMY-3021.
A hazard ratio < 1 indicates an advantage for BzmbR-CAP. c Based on Kaplan-Meier product limit estimates.
Razmerje tveganja < 1 predstavlja prednost za skupino BzmbR-CAP. c Ocena po metodi Kaplan-Meier.
Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
Bortezomib je povzročil zmanjšanje rasti tumorja in vivo v mnogih predkliničnih tumorskih modelih, vključno z modelom diseminiranega plazmocitoma.
1.2 Before administration, visually inspect the solution for particulate matter and discolouration.
1.2 Pred dajanjem vizualno preverite, ali raztopina vsebuje delce in ali je barva spremenjena.
Overall, bortezomib was administered for the treatment of multiple myeloma in 3,974 patients.
Za zdravljenje diseminiranega plazmocitoma je bortezomib prejelo skupno 3.974 bolnikov.
Although in patients aged ≥ 75 years, both BzmbR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzmbR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Čeprav so bolniki, stari ≥ 75 let, slabše prenašali oba režima zdravljenja, BzmbR-CAP in R-CHOP, je bila stopnja resnih neželenih učinkov v skupini BzmbR-CAP 68 % v primerjavi z 42 % v skupini R
Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Cushingov sindrom*, hipertiroidizem*, motnje izločanja antidiuretičnega hormona
The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
TTP je bila 6,5 meseca pri bolnikih, ki so prejemali samo bortezomib, v primerjavi z 9,3 meseca pri tistih, ki so prejemali kombinirano zdravljenje z bortezomibom in pegiliranim liposomskim doksorubicinom.
Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
375 mg/m2 rituksimaba, 750 mg/m2 ciklofosfamida in 50 mg/m2doksorubicina.
Overall response (CR+CRu+PR)h n(%)
Celokupni odziv (CR+CRu+PR)h n(%)
In this case, the duration of a treatment cycle is 42 days (6 weeks).
V tem primeru traja en krog 42 dni (6 tednov).
A total of 74 evaluable patients were administered dexamethasone in combination with bortezomib.
Odziv na zdravljenje so ocenili pri skupaj 74 bolnikih, ki so prejeli deksametazon v kombinaciji z bortezomibom.
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.
Bortezomib was not genotoxic when tested in the in vitro mutagenicity assay (Ames assay) and in vivo micronucleus assay in mice.
Bortezomib se ni izkazal za genotoksičnega v in vitro preskusu mutagenosti (Amesov preskus) in v in vivo mikronukleusnem preskusu pri miših.
visual loss or disturbances and shortness of breath - memory loss, trouble thinking, difficulty with walking or loss of vision.
izguba ali motnje vida ali težko dihate, - če doživite izgubo spomina, imate težave z mišljenjem, s hojo ali se vam poslabša vid.
Subcutaneous or intravenous use only.
Samo za subkutano ali intravensko uporabo.
The incidence of herpes zoster among patients in the BzmbR-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 BzmbR-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).
Note: An OR > 1 indicates an advantage for Bzmb-containing induction therapy.
Opomba: OR > 1 kaže na prednost uvajalnega zdravljenja z Bzmb.
Cycles 1 to 4
krog 2 do 4b
Reduce Bortezomib SUN to 1.0 mg/m2
zmanjšajte odmerek zdravila Bortezomib SUN na 1,0 mg/m2
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Če se ne porabi takoj, je za čas in pogoje shranjevanja zdravila po rekonstituciji odgovoren uporabnik.
Patients eligible for stem cell transplantation
Bolniki, primerni za presaditev krvotvornih matičnih celic
Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib SUN treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Prilagoditev odmerjanja med zdravljenjem in pri ponovni uvedbi zdravljenja v obliki monoterapije Zdravljenje z zdravilom Bortezomib SUN morate prekiniti ob pojavu katere koli nehematološke toksičnosti 3. stopnje ali katere koli hematološke toksičnosti 4. stopnje, z izjemo nevropatije, kot je opisano v nadaljevanju (glejte tudi poglavje 4.4).
Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy
Stopnja 4 (posledice, ki ogrožajo življenje;potrebno je nujno ukrepanje ) in/ali močna avtonomna nevropatija ukinite zdravljenje z zdravilo Bortezomib SUN
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 nezdravljenim 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 %).
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 med zdravljenjem z bortezomibom (intravensko), pred uporabo bortezomiba niso imeli nobenih znakov ortostatske hipotenzije.
Dexamethasone was administered in combination with bortezomib to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
V 1. krogu zdravljenja je skupaj z bortezomibom prejemalo deksametazon 83 bolnikov, v nadaljnjih krogih zdravljenja z bortezomibom pa še dodatnih 11 bolnikov.
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 so pnevmonitis, intersticijska pljučnica, infiltracija pljuč in sindrom akutne respiratorne stiske (SARS) (glejte poglavje 4.8).
One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BzmbTDx and TDx groups, respectively.
Eno avtologno presaditev krvotvornih matičnih celic so opravili pri 105 (81 %) bolnikih v skupini BzmbTDx in pri 78 (61 %) bolnikih v skupini TDx.
Median follow-up was 16.3 months.
Po vmesni analizi so še naprej spremljali preživetje; mediana je bila 16,3 meseca.