natgillin/translations-raw huggingface dataset:
Brain imaging, preferably Magnetic Resonance Imaging (MRI), is used to confirm the diagnosis.
Diagnozo potrdimo s slikovnimi preiskavami možganov, najbolje z magnetnoresonančnim slikanjem (MRIMagnetic Resonance Imaging).
You will have to take regular blood tests before and during your treatment with Bortezomib SUN, to check your blood cell counts regularly.
Pred in med zdravljenjem z zdravilom Bortezomib SUN vam bodo redno pregledovali kri in tako spremljali število krvnih celic.
Intravenous use: Add 3.5 ml 0.9% sodium chloride to make 1 mg/ml final concentration.
Intravenska uporaba: dodajte 3,5 ml sterilne 0,9 % raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib SUN
Nehematološka toksičnost stopnje ≥ 3, povezana z uporabo zdravila Bortezomib SUN
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla
Response parameters as well as TTP remained significantly better for bortezomib independently of age.
Parametri odziva na zdravljenje, kot tudi čas do napredovanja bolezni (time to progression, TTP) so bili, neodvisno od starosti, pri zdravljenju z bortezomibom statistično značilno boljši.
d Based on Log rank test stratified with IPI risk and stage of disease.
d Na podlagi log-rank testa, stratificiranega z IPI-tveganjem in stadijem bolezni.
A drug-drug interaction study assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 35% (CI90% [1.032 to 1.772]) based on data from 12 patients.
Študija medsebojnega delovanja zdravil, ki je ocenjevala učinek ketokonazola, močnega inhibitorja CYP3A4, na farmakokinetiko bortezomiba (danega intravensko), je na podlagi podatkov 12 bolnikov pokazala povprečen dvig AUC bortezomiba za 35 % (CI 90 % (1.032 do 1.772)).
Patient demographic and baseline disease characteristics were similar between the treatment groups.
Bolniki v obeh skupinah so imeli podobne demografske in bolezenske značilnosti.
Elderly MCL patients 42.9% and 10.4% of patients in the BzmbR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
V skupini BzmbR-CAP je bilo 42,9 % bolnikov starih 65-74 let in 10,4 % bolnikov starih ≥ 75 let.
The following information is intended for healthcare professionals only: Only the 3.5 mg vial can be administered subcutaneously, as described below.
Kot je navedeno spodaj, se lahko daje subkutano samo 3,5 mg viala.
The following medicinal products are administered on day 1 of each Bortezomib SUN 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Zdravila, ki se dajejo v obliki intravenske infuzije na 1. dan vsakega 3-tedenskega kroga zdravljenja z zdravilom Bortezomib SUN, so: 375 mg/m2 rituksimaba, 750 mg/m2 ciklofosfamida in 50 mg/m2 doksorubicina.
Patients should be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML as part of the differential diagnosis of CNS problems.
Kot del diferencialne diagnoze težav CŽS je pri bolnikih treba redno spremljati pojav novih ali poslabšanje nevroloških simptomov ali znakov, ki bi lahko nakazovali na PML.
Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported during bortezomib treatment.
Med zdravljenjem z bortezomibom so poročali o akutnem razvoju ali poslabšanju kongestivnega srčnega popuščanja in/ali novim pojavom zmanjšanja iztisne frakcije levega prekata.
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/Ολλανδία/ Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
1.4 mo
1,4 meseca
A Phase II, single arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi agent re induction chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
V farmakokinetični študiji varnosti in učinkovitosti faze II, z enim krakom, ki jo je izvedla Skupina za otroško onkologijo (COG- Children's Oncology Group) so ocenili delovanje bortezomiba, ki so Ga dodali k ponovno uvedeni indukcijski kemoterapiji z več zdravili pri pediatričnih in mladih odraslih bolnikih z limfatičnimi malignomi (s pre-B-celično akutno limfoblastno levkemijo [ALL], T-celično
This study included 222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m2 of bortezomib by either the subcutaneous or intravenous route for 8 cycles.
V študijo je bilo vključenih 222 bolnikov z relapsom/diseminiranim plazmocitomom, odpornim na zdravljenje, randomiziranih 2:1 na bortezomib v odmerku 1,3 mg/m2 telesne površine subkutano ali intravensko 8 krogov zdravljenja.
d p-value from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) NA=not applicable, NE=not estimated TTP-Time to Progression
c Populacija oz. skupina bolnikov, pri kateri so ovrednotili odziv na zdravljenje, vključuje bolnike, ki so imeli merljivo bolezen na začetku in so prejeli najmanj en odmerek raziskovalnega zdravila d P-vrednost iz Cochran-Mantel-Haenszelovega hi-kvadrat testa, korigiranega s faktorji stratifikacije; v analizi po vrsti terapije ni bila vključena stratifikacija po terapevtski anamnezi * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+) NA=ne velja za ta primer, NE=odziva ni bilo mogoče oceniti TTP=čas do napredovanja bolezni CI=interval zaupanja
In multi-cycle general toxicity studies conducted in the rat and monkey, the principal target organs included the gastrointestinal tract, resulting in vomiting and/or diarrhoea; haematopoietic and lymphatic tissues, resulting in peripheral blood cytopenias, lymphoid tissue atrophy and haematopoietic bone marrow hypocellularity; peripheral neuropathy (observed in monkeys, mice and dogs) involving sensory nerve axons; and mild changes in the kidneys.
V raziskavah splošne toksičnosti z več krogi zdravljenja na podganah in opicah so bili poglavitni tarčni organi prebavila s posledičnim bruhanjem in/ali drisko ter krvotvorni organi s posledičnim zmanjšanjem števila krvnih celic v periferni krvi, zmanjšanjem limfatičnega tkiva ter hipocelularnostjo kostnega mozga, periferno nevropatijo (ki so jo opažali pri opicah, miših in psih) s prizadetostjo senzoričnih živčnih končičev in blagimi spremembami ledvic.
In patients developing PRES, bortezomib should be discontinued.
Če se pri bolniku razvije PML, je treba zdravljenje z bortezomibom prekiniti.
Caution is advised when treating patients with a history of syncope receiving medicinal products known to be associated with hypotension; or who are dehydrated due to recurrent diarrhoea or vomiting.
ki prejemajo zdravila, za katera je znano, da so povezana s pojavom hipotenzije, ali pri tistih, ki so dehidrirani zaradi ponavljajoče se driske ali bruhanja, svetujemo previdnost.
Special populations
populacija)
Mediana response duration
Medianaa trajanja odziva CRf
Electrocardiogram investigations
Elektrokardiogram (EKG)
The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
Primarna ocena učinkovitosti je bila stopnja odziva po uvedbi zdravljenja in po presaditvi (CR+nCR).
The protocol allowed patients to receive dexamethasone if they had had a less than optimal response to bortezomib alone.
V skladu s protokolom so bolniki lahko prejeli deksametazon, če ni bilo optimalnega odziva na zdravljenje z bortezomibom v monoterapiji.
An effective reinduction multiagent chemotherapy regimen was administered in 3 blocks.
Bolnikom so uvedli učinkovito indukcijsko kemoterapijo z več zdravili v 3 sklopih.
Serious adverse reactions uncommonly reported during treatment with bortezomib include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
Med zdravljenjem z bortezomibom so občasno poročali o resnih neželenih učinkih - srčno popuščanje, sindrom razpada tumorja, pljučna hipertenzija, sindrom reverzne posteriorne encefalopatije, akutna difuzna infiltracijska pljučna stanja - in redko o avtonomni nevropatiji.
Patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Bolniki, ki prejemajo bortezomib v kombinaciji s talidomidom, morajo upoštevati program preprečevanja nosečnosti, kot je predpisan pri talidomidu.
Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration (see section 4.2).
Če se zakasnitve krogov zdravljenja ponavljajo, je treba razmisliti o profilaktični uporabi granulocitne kolonije spodbujajočih faktorjev (glejte poglavje 4.2).
Such changes may be reversible upon discontinuation of bortezomib (see section 4.8).
Po prekinitvi zdravljenja z bortezomibom so te spremembe lahko reverzibilne (glejte poglavje 4.8).
There was a trend towards prolonged overall survival favouring the BzmbR-CAP group; the estimated 4-year survival rate was 53.9% in the R-CHOP group and 64.4% in the BzmbR-CAP group.
Ocenjena stopnja 4-letnega preživetja je bila v skupini R-CHOP 53,9 % in v skupini BzmbR-CAP
Your doctor will work out your dose of Bortezomib SUN according to your height and weight (body surface area).
Zdravnik bo določil odmerek na podlagi vaše telesne višine in mase (telesne površine).
Haematological toxicity during a cycle - If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
Hematološka toksičnost med zdravljenjem - Če je bila v prejšnjem krogu zdravljenja opažena dolgotrajna nevtropenija 4. stopnje, trombocitopenija ali trombocitopenija in
Bilirubin level
Koncentracija bilirubina
For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify Bortezomib SUN as outlined in Table 1.
V primeru nevropatske bolečine in/ali periferne nevropatije, povezane z bortezomibom, zakasnite in/ali prilagodite odmerek zdravila Bortezomib SUN, kot je opisano v preglednici 1.
There have been isolated cases of QT-interval prolongation in clinical studies, causality has not been established.
Vzroka za podaljšanje QT-intervala niso ugotovili.
In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BzmbTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
V študiji MMY-3010 so primerjali uvajalno zdravljenje z bortezomibom v kombinaciji s talidomidom in deksametazonom [BzmbTDx, n=130] s kombinacijo talidomid-deksametazon [TDx, n=127].
MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV
69 % bolnikov je imelo pozitivno aspiracijo kostnega mozga in/ali pozitivno biopsijo kostnega mozga za MCL, 54 % bolnikov je imelo vrednost mednarodnega prognostičnega indeksa (International Prognostic Index-IPI) ≥ 3 in 76 % bolnikov je bilo v IV. stadiju bolezni.
In the 6-month rat study, degenerative effects in both the testes and the ovary have been observed.
V 6-mesečni raziskavi na podganah so opažali degenerativne učinke tako na testise kot na ovarije, zato je verjetno, da bi bortezomib lahko vplival na plodnost samic ali samcev.
- Platelet counts should be ≥ 100,000 cells/μl and the absolute neutrophils count (ANC) should be ≥ 1,500 cells/μl
- Število trombocitov mora biti ≥ 100.000 celic/μl in celokupno število nevtrofilcev (ANC
The pharmacokinetics of bortezomib are not influenced in patients with mild to moderate renal impairment (Creatinine Clearance [CrCL] > 20 ml/min/1.73 m2); therefore, dose adjustments are not necessary for these patients.
Pri bolnikih z blago do zmerno okvaro ledvic (očistek kreatinina [CrCL] > 20 ml/min/1,73 m2) farmakokinetika bortezomiba ni spremenjena, zato pri njih ni treba prilagajati odmerka.
In trials in which bortezomib was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Pojavnost periferne nevropatije v preskušanjih bortezomiba pri uvajalnem zdravljenju v kombinaciji z deksametazonom (študija IFM-2005-01) ter deksametazonom in talidomidom (študija MMY-3010) je navedena v spodnji preglednici:
• to report any adverse event, or medication error experienced with the administration of Bortezomib SUN 3.5 mg.
• Pomembnost sporočanja kakršnihkoli neželenih učinkov ali napak pri uporabi zdravila Bortezomib SUN 3,5 mg.
Patients should be instructed to seek medical advice if they experience symptoms of dizziness, light-headedness or fainting spells.
naj se posvetujejo z zdravnikom, če imajo simptome omotice, vrtoglavice ali napade nezavesti.
18.3 mo
18,3 meseca
Each carton of Bortezomib SUN 3.5 mg powder for solution for injection contains a clear glass 10 ml vial closed with a light green aluminium cap, in a transparent blister pack.
Ena škatla zdravila Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje vsebuje prozorno stekleno 10 ml vialo s svetlo zeleno aluminijasto zaporko v prozornem pretisnem omotu.
The mean platelet count nadir measured was approximately 40% of baseline in the single-agent multiple myeloma studies and 50% in the MCL study.
Povprečna vrednost najnižjega izmerjenega števila trombocitov je v študijah diseminiranega plazmocitoma z uporabo ene učinkovine znašala približno 40 % in v študiji MCL 50 % začetne vrednosti.
T 100 mga
T 100 mga na dan na dan
In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
V študijah zdravljenja z bortezomibom pri bolnikih s ponovitvijo diseminiranega plazmocitoma in pri bolnikih z nezdravljenim MCL, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (BzmbR-CAP), je bil eden od najpogostejših toksičnih učinkov na hematološki sistem prehodna trombocitopenija.
- Platelet counts should be ≥ 70 x 109/l and the absolute neutrophils count should be ≥ 1.0 x 109/l
Neutrophil Count) mora biti ≥ 1,0 x 109/l.
T 50 mg
T 50 mg na dan na dan
Dose adjustments for combination therapy for patients with progressive multiple myeloma For Bortezomib SUN dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
Prilagoditev odmerjanja pri kombiniranem zdravljenju bolnikov z diseminiranim plazmocitomom Za prilagoditev odmerjanja zdravila Bortezomib SUN pri kombiniranem zdravljenju upoštevajte navodila za samostojno zdravljenje, opisana zgoraj.
Deboronated-bortezomib metabolites are inactive as 26S proteasome inhibitors.
Presnovka, ki nastaneta po odcepitvi bora, ne delujeta kot zaviralca 26S-proteasoma.
Intent to Treat Populationb n=74
Populacija bolnikov, ki naj bi jo zdravili (ITT)b n=74
You may experience a reduction in the number of: - platelets, which may make you be more prone to bruising, or to bleeding without obvious injury (e.g., bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver) - red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness - white blood cells may make you more prone to infections or flu-like symptoms.
- krvnih ploščic, zaradi česar ste lahko bolj dovzetni za podplutbe ali krvavitve brez očitnih poškodb (npr.: krvavitve v črevesju, želodcu, ustih in dlesnih ali krvavitve v možganih ali jetrih); - rdečih krvnih celic, kar lahko vodi v anemijo, s simptomi, kot sta utrujenost in bledica; - belih krvnih celic, zato boste bolj dovzetni za okužbe ali gripi podobne simptome.
b Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
b Ocena razmerja tveganja na podlagi Coxovega modela, stratificirana z IPI-tveganjem in stadijem bolezni.
Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001) A Phase III randomised, parallel-group, open-label, multicentre study was conducted in 646 patients comparing the safety and efficacy of bortezomib plus pegylated liposomal doxorubicin versus bortezomib monotherapy in patients with multiple myeloma who had received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy.
Bortezomib v kombinaciji s pegiliranim liposomskim doksorubicinom (študija DOXIL-MMY-3001) Pri 646 bolnikih je bila opravljena randomizirana, odprta, multicentrična študija faze III pri vzporednih skupinah, v kateri so primerjali varnost in učinkovitost kombinirane terapije z bortezomibom in pegiliranim liposomskim doksorubicinom z monoterapijo z bortezomibom pri bolnikih z diseminiranim plazmocitomom, ki so že prejeli najmanj eno vrsto terapije in pri katerih bolezen ni napredovala med prejemanjem antraciklinske terapije.
No new safety concerns were observed during the study, and in particular bortezomib did not exacerbate target organ damage (heart, kidney and liver).
Uporaba bortezomiba ni povečala poškodb tarčnih organov (srce, ledvice, jetra).
Notable differences in the safety profile of bortezomib administered subcutaneously versus intravenously as single agent
Pomembne razlike v varnostnem profilu uporabe bortezomiba v monoterapiji subkutano oz.
Aseptic technique must be strictly observed throughout the handling of Bortezomib SUN, since it contains no preservative.
MED RAVNANJEM Z ZDRAVILOM BORTEZOMIB SUN MORATE VES ČAS STROGO UPOŠTEVATI ASEPTIČNO PRIPRAVO, SAJ ZDRAVILO NE VSEBUJE KONZERVANSA.
Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Varnost in učinkovitost bortezomiba (injicirano intravensko) v priporočenem odmerku 1,3 mg/m2 so ovrednotili v dveh preskušanjih: v randomiziranem, primerjalnem (primerjava z deksametazonom (Dex)) preskušanju faze III (APEX) pri 669 bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje, ki so pred tem že prejeli 1 do 3 vrste terapije ter v enodelnem preskušanju druge faze pri 202 bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje, ki so pred tem že prejeli najmanj 2 vrsti terapije in je bolezen ob zadnji vrsti terapije napredovala.
Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
Ena viala vsebuje 3,5 mg bortezomiba (v obliki estra manitola in borove kisline).
(listed in section 6) - if you have certain severe lung or heart problems.
- če imate določene hude težave s pljuči ali srcem.
These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.
To so lahko znaki resne okužbe možganov.
Week Bzmb (1.3 mg/m2) Day 1, 4
Teden Bzmb (1,3 mg/m2) dan 1, 4
The most commonly reported adverse reactions during treatment with bortezomib are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia.
Med zdravljenjem z bortezomibom so najpogosteje poročali o navzei, diareji, zaprtosti, bruhanju, utrujenosti, pireksiji, trombocitopeniji, anemiji, nevtropeniji, periferni nevropatiji (vključno s senzorično nevropatijo), glavobolu, paresteziji, zmanjšanem apetitu, dispneji, izpuščaju, virusu herpes zostru in mialgiji.
No clinical data are available for bortezomib with regard to exposure during pregnancy.
Nosečnost Za bortezomib ni na voljo kliničnih podatkov nosečnic, ki so bile izpostavljene zdravilu.
Bortezomib was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Bolniki so prejeli zdravilo bortezomib le v 1. in 2. sklopu zdravljenja, da so izognili prekrivanju toksičnih učinkov z drugimi, sočasno danimi zdravili v 3. sklopu zdravljenja.
How to use Bortezomib SUN
Kako uporabljati zdravilo Bortezomib SUN
Bortezomib SUN will be administered by a health care professional experienced in the use of cytotoxic medicines.
Zdravilo Bortezomib SUN vam bo injiciral zdravstveni delavec, izkušen v uporabi citotoksičnih zdravil.
Medianc(95% CI) (months) Response rate n: response-evaluable patients Overall complete response (CR+CRu)f n(%)
medianac(95 % CI) (meseci) Stopnja odziva n: odziv preiskovanih bolnikov
Hepatic failure, Hepatomegaly, Budd-Chiari syndrome, Cytomegalovirus hepatitis, Hepatic haemorrhage, Cholelithiasis
Redki odpoved jeter, hepatomegalija, Budd-Chiarijev sindrom, citomegalovirusni hepatitis, krvavitev v jetrih, holelitiaza
Bortezomib therapy should be withheld when the platelet count is < 25,000/μl or in combination with melphalan and prednisone when the platelet count is ≤ 30,000/μl (see section 4.2).
< 25.000/μl ali če se bolnik zdravi z bortezomibom v kombinaciji z melfalanom in prednizonom ter je število trombocitov ≤ 30.000/μl (glejte poglavje 4.2).
This 3-week period is considered a treatment cycle.
To 3-tedensko obdobje predstavlja en krog zdravljenja.
24.0 mo
24,0 meseca
Bortezomib SUN dose should be reduced by 1 dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2)
Odmerek zdravila Bortezomib SUN je treba zmanjšati za 1 stopnjo (z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m2 na 0,7 mg/m2)
PHARMACEUTICAL FORM Powder for solution for injection.
Prašek za raztopino za injiciranje.
- In cycles 1 to 4, Bortezomib SUN is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29
- V krogih od 1 do 4 se zdravilo Bortezomib SUN daje dvakrat na teden, 1., 4., 8., 11., 22., 25.,
Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Število trombocitov je bilo najmanjše 11. dan vsakega kroga zdravljenja z bortezomibom in se je do naslednjega kroga zdravljenja navadno povrnilo na začetno vrednost.
Common Weight decreased Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*, C-reactive protein increased
Občasni hiperbilirubinemija*, nenormalni izvidi analiz proteinov*, zvečana telesna masa, nenormalni izvidi krvnih preiskav*, zvišana koncentracija C-reaktivnega proteina
Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma
Preglednica 5: Prilagajanje odmerkov med zdravljenjem pri bolnikih s predhodno nezdravljenim limfomom plaščnih celic Toksičnost
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.
Tako pri bolnikih s plazmocitomom, odpornim na zdravljenje, po prejšnji vrsti zdravljenja, kot pri tistih, ki so se odzvali na zdravljenje, je bilo celokupno preživetje v skupini, ki je prejemala bortezomib, statistično značilno daljše in odziv na zdravljenje je bil statistično značilno boljši.