natgillin/translations-raw huggingface dataset:
In study IFM-2005-01 bortezomib combined with dexamethasone [BzDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
V študiji IFM-2005-01 so primerjali kombinacijo bortezomiba in deksametazona [BzDx, n=240] s kombinacijo vinkristin-doksorubicin-deksametazon BzDx, n=242].
• ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Hematološka toksičnost • nevtropenija z zvečano telesno temperaturo stopnje ≥ 3, nevtropenija 4. stopnje, ki traja več kot 7 dni, število trombocitov < 10.000 celic/μl
ORR (CR+PR) p-valuea CR n (%) PR n (%) nCR n (%)
ORR (CR+PR) p-vrednosta CR n (%) PR n (%) nCR n (%)
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA ZA PROMET
Response Rate at 4 cycles n (%)
Stopnja odziva v 4. krogu n (%)
Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Pri bolnikih z diseminiranim plazmocitomom se po intravenski bolusni ali subkutani injekciji pri odmerku 1,3 mg/m2 (n=14 pri intravenski in n=17 pri subkutani skupini) je bila skupna sistemska izpostavljenost po ponovljenem odmerku (AUCzadnji) ekvivalentna pri subkutanem in intravenskem dajanju.
Table 6: Recommended starting dose modification for Bortezomib Accord in patients with hepatic impairment
Preglednica 6: Priporočena prilagoditev začetnega odmerka zdravila Bortezomib Accord pri bolnikih z boleznijo jeter
Bortezomib Accord is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Zdravilo Bortezomib Accord dajte subkutano v stegno (desno ali levo) ali trebuh (desno ali levo).
Your doctor will work out your dose of Bortezomib Accord according to your height and weight (body surface area).
Zdravnik bo določil odmerek na osnovi vaše telesne višine in mase (telesne površine).
• If several Bortezomib Accord doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Bortezomib Accord v enem krogu zdravljenja (≥ 3 odmerke pri odmerjanju dvakrat na teden ali ≥ 2 odmerka pri odmerjanju enkrat na teden)
Time to progression
Čas do odziva
Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzR-CAP arm.
V BzR-CAP kraku študije je protivirusna zdravila prejelo 137 od 240 bolnikov (57%).
Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/µl were excluded.
bolniki, ki so imeli na začetku študije stopnjo periferne nevropatije ≥ 2 ali število trombocitov <50,000/µl, so bili izključeni.
Response Rate at 8 cycles n (%)
Stopnja odziva v 8. krogu n (%)
You may also be given Bortezomib Accord together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Lahko pa boste zdravilo Bortezomib Accord prejeli skupaj z zdraviloma pegilirani liposomski doksorubicin ali deksametazon.
Change Bortezomib Accord treatment schedule to 1.3 mg/m2 once per week
ali spremenite shemo zdravljenja z zdravilom Bortezomib Accord na odmerek 1,3 mg/m2 enkrat na teden
An effective reinduction multiagent chemotherapy regimen was administered in 3 blocks.
Bolnikom so ponovno uvedli učinkovito indukcijsko kemoterapijo z več zdravili v 3 sklopih.
d Based on Log rank test stratified with IPI risk and stage of disease.
d Na osnovi Log rank testa, stratificiranega z IPI tveganjem in stopnjo bolezni.
• Serious allergic reaction (anaphylactic shock) signs of which may include difficulty breathing, chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse
• znaki hude alergijske reakcije (anafilaktične reakcije), ki lahko vključujejo oteženo dihanje, bolečino ali tiščanje v prsih, in/ali omotico/omedlevico, hudo srbenje kože ali dvignjene bulice na koži, otekanje obraza, ustnic, jezika in/ali grla, kar lahko povzroči oteženo požiranje, kolaps
Events (deaths) n (%) Mediana
dogodki (smrti) n (%)
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone group.
Opazili so statistično značilno razliko v Cr+nCR v prid skupine, ki je prejemala bortezomib in deksametazon.
If you are given Bortezomib Accord together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:
Če prejemate zdravilo Bortezomib Accord skupaj z drugimi zdravili za zdravljenje limfoma plaščnih celic, se lahko pri vas pojavijo naslednji neželeni učinki:
In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BzTDx, 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 [BzTDx, n=130] s kombinacijo thalidomid-deksametazon [TDx, n=127].
Be sure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Na viali preverite koncentracijo, da zagotovite pravilni odmerek za intravensko dajanje zdravila (1 mg/ml).
Bortezomib Accord is administered via intravenous or subcutaneous injection in combination with oral melphalan and oral prednisone as shown in Table 2.
Kombinirano zdravljenje z melfalanom in prednizolonom Zdravilo Bortezomib Accord se daje intravensko ali subkutano v kombinaciji s peroralnim melfalanom in prednizolonom, kot je prikazano v preglednici 2.
HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-CAP).
Do okužbe s HBV s smrtnim izidom je prišlo pri 0,8% (n=2) bolnikov v skupini, ki ni prejemala bortezomiba (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon; skupina R-CHOP) in pri 0,4% (n=1) bolnikov v skupini, ki je prejemala bortezomib v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (skupina BzR-CAP).
Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Občasni duševne motnje*, halucinacije*, psihotične motnje*, zmedenost*,
RR (Post-transplant)
RR (po presaditvi)
A hazard ratio < 1 indicates an advantage for BzR-CAP. c Based on Kaplan-Meier product limit estimates.
predstavlja prednost za skupino BzR-CAP. c Ocena po metodi Kaplan-Meier.
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 BzR-CAP (n=240)
In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to bortezomib were in the range 65-74 years and ≥ 75 years of age, respectively.
V študiji z bortezomibom pri bolnikih, pri katerih limfom plaščnih celi še ni bil zdravljen, je bilo 42,9% bolnikov starih 65-74 let in 10,4% bolnikov starih ≥ 75 let.
• dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Bortezomib Accord (both intravenous and subcutaneous use) required for different body surface areas.
• Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volumen rekonstituiranega zdravila Bortezomib Accord (za intravensko in subkutano uporabo) glede na različne telesne površine.
Posology for treatment of progressive multiple myeloma (patients who have received at least one prior therapy)
Priporočeno odmerjanje pri zdravljenju diseminiranega plazmocitoma (bolniki, ki so pred tem že prejeli eno vrsto terapije)
In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of Grade ≥ 2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
V študiji faze III z bortezomibom, ki je primerjala intravensko in subkutano dajanje zdravila, je bila pogostnost dogodkov periferne nevropatije ≥ 2. stopnje v skupini, ki je prejemala zdravilo subkutano 24%, v skupini, ki je prejemala zdravilo intravensko pa 41% (p=0,0124).
Bortezomib Accord should not be administered intrathecally.
Zdravila Bortezomib Accord se ne sme dajati intratekalno.
Bortezomib Accord 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 Accord 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)
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.
Klinična učinkovitost pri relapsu ali diseminiranem plazmocitomu, odpornem na zdravljenje 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.
> 1.5 x −3 x ULN
> 1,5x−3x ULN katera koli
You will have to take regular blood tests before and during your treatment with Bortezomib Accord, to check your blood cell counts regularly.
Pred in med zdravljenjem z zdravilom Bortezomib Accord vam bodo redno pregledovali kri in tako spremljali število krvnih celic.
The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Varnostni profil bortezomiba pri 240 bolnikih, zdravljenih z bortezomibom v odmerku 1,3 mg/m2 telesne površine, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (BzR-CAP) v primerjavi z 242 bolniki, zdravljenimi z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom [R-CHOP], je bil relativno skladen s profilom, opaženim pri bolnikih z diseminiranim plazmocitomom.
42.9% and 10.4% of patients in the BzR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
V skupini BzR-CAP je bilo 42,9% bolnikov starih 65-74 let in 10,4% bolnikov, starih ≥ 75 let.
Grade of hepatic impairment*
Stopnja jetrne okvare*
The following medicinal products are administered on day 1 of each bortezomib 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 bortezomibom so: 375 mg/m2 rituksimaba, 750 mg/m2 ciklofosfamida in 50 mg/m2 doksorubicina.
• dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Bortezomib Accord (both intravenous and subcutaneous use) required for different body surface areas (cross reference to Dosing Slide Rule)
• Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volumen rekonstituiranega zdravila Bortezomib Accord (za intravensko in ssubkutano uporabo) glede na različne telesne površine (v povezavi z navodili za odmerjanje).
When Bortezomib Accord is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Če jemljete zdravilo Bortezomib Accord v kombinaciji s talidomidom, morate upoštevati program za preprečevanje nosečnosti, ki velja za talidomid (glejte navodilo za uporabo talidomida).
b Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
b Bolniki, ki dosežejo vsaj delni odgovor po 4 krogih, lahko prejmejo do 6 krogov zdravljenja.
Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Redko so poročali o reakcijah povzročenih z imunokompleksi, kot so serumska bolezen, poliartritis z izpuščajem in proliferativni glomerulonefritis.
In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/µl, 90% of 21 patients had a count ≤ 25,000/µl during the study, including 14% < 10,000/µl; in contrast, with a baseline platelet count > 75,000/µl, only 14% of 309 patients had a count ≤ 25,000/µl during the study.
Pri bolnikih, z napredovalim plazmocitomom, je bila resnost trombocitopenije povezana s številom trombocitov pred zdravljenjem (90 % od 21 bolnikov, ki so imeli začetno število trombocitov < 75.000/µl, je med preskušanjem imelo število trombocitov ≤ 25.000/µl (vključno s 14% bolnikov, ki so imeli število trombocitov < 10.000/µl).
In B-ALL patients with relapse 18-36 months from diagnosis (n = 33) the CR rate was 79% (95% CI: 61, 91) and the 4-month event free survival rate was 73% (95% CI: 54, 85).
Pri bolnikih z B-celično ALL in relapsom po 18-36 mesecev po diagnozi (n = 33) je bil delež popolnih odgovorov 79 % (95% CI: 61, 91) in delež 4-mesečnega preživetja bolnikov brez dogodkov 73 % (95% CI: 54, 85).
Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported during bortezomib treatment.
Srčno popuščanje Med zdravljenjem z bortezomibom so poročali o akutnem razvoju ali poslabšanju kongestivnega srčnega popuščanja in/ali novim pojavom zmanjšanja iztisne frakcije levega prekata.
Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (BzR-CAP)
Kombinirano zdravljenje z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (BzR-CAP)
The MAH shall ensure thatall healthcare professionals involved in the prescribing, dispensing, handling or administration of Bortezomib Accord are provided with educational material.
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bodo vsi zdravstveni delavci, ki bodo predpisovali ali uporabljali zdravilo Bortezomib Accord, prejeli izobraževalno gradivo.
Table 7:Adverse reactions in patients with Multiple Myeloma treated with Bortezomib in clinical trials, and all post-marketing adverse reactions regardless of indication
Preglednica 7: Neželeni učinki pri bolnikih z diseminiranim plazmocitomom, zdravljenih z bortezomibom v kliničnih preskušanjih in v obdobju trženja, neodvisno od indikacije
Subcutaneous administration:
Subkutano dajanje:
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
- 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
Aseptic technique must be strictly observed throughout the handling of Bortezomib Accord, since it contains no preservative.
MED RAVNANJEM Z ZDRAVILOM BORTEZOMIB ACCORD MORATE VES ČAS STROGO UPOŠTEVATI ASEPTIČNO PRIPRAVO, SAJ ZDRAVILO NE VSEBUJE KONZERVANSA.
• Pneumonia • Loss of appetite
• izguba apetita
• If, after Bortezomib Accord has been held, the toxicity does not resolve, as defined above, then Bortezomib Accord must be discontinued.
Bortezomib Accord toksičnost ne mine kot je opisano zgoraj, je treba zdravljenje z zdravilom Bortezomib Accord ukiniti.
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
ANNEX II A MANUFACTURERS 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
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z
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 potrebno redno spremljati pojav novih ali poslabšanje nevroloških simptomov ali znakov, ki bi lahko nakazovali na PML.
b Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
b Ocena razmerja tveganja na osnovi Coxovega modela, stratificirani z IPI tveganjem in stopnjo bolezni.
Bortezomib treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Zdravljenje z bortezomibom je zelo pogosto povezano z zmanjšanjem števila krvnih celic (trombocitopenija, nevtropenija in anemija).
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.
Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
Bolnike so glede na vrednost očistka kreatinina (CrCL) razdelili v naslednje skupine: normalno delovanje ledvic (CrCL ≥ 60 ml/min/1,73 m2, n=12), blaga okvara ledvic (CrCL=40-59 ml/min/1,73 m2, n=10), zmerna okvara ledvic (CrCL=20-39 ml/min/1,73 m2, n=9),
every 3 weeks for maximum of 8 cycles either as single agent or in combination with dexamethasone in accordance with the standard of care.
Zdavilo so prejemali na 1., 4., 8., in 11. dan vsake tri tedne, največ 8 krogov zdravljenja kot samostojno zdravljenje ali v kombinaciji z deksametazonom, skladno s klinično prakso.
Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Diseminirani plazmocitom Za neželene učinke, navedene v Preglednici 7, so raziskovalci menili, da imajo vsaj možno do verjetno vzročno povezavo z bortezomibom.
For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify Bortezomib Accord as outlined in Table 1.
V primeru nevropatske bolečine in/ali periferne nevropatije povezane z bortezomibom zakasnite in/ali prilagodite odmerek zdravila Bortezomib Accord, kot je opisano v preglednici 1.
Angioedema#, Hypersensitivity*
Občasni angioedem#, preobčutljivost*
The median OS was 30.8 months (95% CI; 25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Mediana OS pri bolnikih na monoterapiji z bortezomibom je bila 30,8 meseca (95% CI: 25,2-36,5 meseca), pri bolnikih, ki so se zdravili s kombinacijo bortezomiba in pegiliranega liposomskega doksorubicina pa 33,0 meseca (95% CI: 28,9-37,1 meseca).
Bortezomib Accord contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Zdravilo Bortezomib Accord vsebuje učinkovino bortezomib, ki je zaviralec proteasomov.
• to report any adverse event, or medication error experienced with the administration of Bortezomib Accord.
• Pomembnost sporočanja kakršnihkoli neželenih učinkov ali napak pri dajanju zdravila Bortezomib Accord.
h n(%)
CR n (%)
• 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.
Week Bz (1.3 mg/m
Teden Bz (1.3 mg/m2)
Reduce Bortezomib Accord to 0.7 mg/m2 in the first treatment cycle.
Zmanjšati odmerek zdravila Bortezomib Accord v prvem krogu zdravljenja na 0,7 mg/m2.
Patients should be closely monitored when given bortezomib in combination with potent CYP3A4-inhibitors.
Zato je potrebno bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4 (npr.
Carriers of hepatitis B and patients with a history of hepatitis B must be closely monitored for clinical and laboratory signs of active HBV infection during and following rituximab combination treatment with bortezomib.
Reaktivacija in okužba z virusom hepatitisa B (HBV) Pri bolnikih s tveganjem za okužbo s HBV je treba pred uporabo rituksimaba v kombinaciji z bortezomibom vedno opraviti presejalni test na HBV. Prenašalce virusa hepatitisa B in bolnike, ki so že bili okuženi z virusom hepatitisa B, je treba med zdravljenjem in v nadaljevanju zdravljenja z rituksimabom v kombinaciji z bortezomibom skrbno spremljati glede kliničnih in laboratorijskih znakov aktivne okužbe s HBV.
Table 3: Posology modifications during subsequent cycles of Bortezomib Accord therapy in combination with melphalan and prednisone
Preglednica 3: Prilagajanje odmerkov med kasnejšimi krogi zdravljenja z zdravilom Bortezomib Accord v kombinaciji z melfalanom in prednizolonom
Events n (%) Mediana (95% CI)
Čas do napredovanja bolezni dogodki n (%) medianaa (95% CI)
What Bortezomib Accord looks like and contents of the pack
Izgled zdravila Bortezomib Accord in vsebina pakiranja
a p-value is for the non-inferiority hypothesis that the subcutaneous arm retains at least 60% of the response rate in the intravenous arm. b 222 subjects were enrolled into the study; 221 subjects were treated with bortezomib c Hazards ratio estimate is based on a Cox model adjusted for stratification factors: ISS staging and number of prior lines.
b V študijo je bilo vključenih 222 preiskovancev; 221 preiskovancev se je zdravilo z bortezomibom c Ocena stopnje tveganja temelji na modelu po Cox-u, prilagojen na osnovi stratifikacijaskih faktorjev: ISS razvrstitvi in številu predhodnih zdravljenj.
Intravenous administration:
Intravensko dajanje:
Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Število nevtrofilcev je bilo najmanjše 11. dan vsakega kroga zdravljenja z bortezomibom in se je do naslednjega kroga zdravljenja običajno povrnilo na začetno vrednost.
1.3 mg/m2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively.
Po ponovljenih odmerkih je bil razpon 15 do 32 l/h za odmerek 1,0 mg/m2 in 18 do 32 l/h za odmerek 1,3 mg/m2.
Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy
Stopnja 4 (posledice, ki ogrožajo življenje;potrebno je nujno ukrepanje )