FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Slovenian: Pogostnost neželenih učinkov je opredeljena, kot sledi: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do < 1/10); občasni
English: 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.
Slovenian: Z mikrobiološkega vidika je treba rekonstituirano zdravilo uporabiti takoj, razen če metoda odpiranja/rekonstitucije/redčenja izključuje tveganje kontaminacije z mikrobi.
English: 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).
Slovenian: 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).
English: TTP, days [95% CI]
Slovenian: TTP dnevi ([95% CI])
English: Bortezomib Accord might cause tiredness, dizziness, fainting, or blurred vision.
Slovenian: Zdravilo Bortezomib Accord lahko povzroči utrujenost, omotičnost, omedlevico ali zamegljen vid.
English: 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.
Slovenian: 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.
English: This includes any possible side effects not listed in this leaflet.
Slovenian: Posvetujte se tudi, če opazite katere koli možne neželene učinke, ki niso navedeni v tem navodilu.
English: 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).
Slovenian: 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).
English: The median duration of complete response was 42.1 months in the BzR-CAP group compared with 18 months in the R-CHOP group.
Slovenian: Mediana trajanja popolnega odgovora je bila 42,1 meseca v skupini BzR-CAP in 18 mesecev v skupini R-CHOP.
English: 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.
Slovenian: 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.
English: ORe (95% CI)=1.428 (0.749; 2.722) p-value g=0.275
Slovenian: ORe (95% CI)=1,428 (0,749; 2,722) p-vrednostg=0,275
English: Table 8 Adverse reactions in patients with Mantle cell lymphoma treated with BzR-CAP in a clinical trial
Slovenian: Preglednica 8: Neželeni učinki pri bolnikih z limfomom plaščnih celic, zdravljenih z BzR-CAP v kliničnih preskušanjih
English: Bortezomib Accord must be reconstituted by a healthcare professional (see section 6.6).
Slovenian: Accord mora rekonstituirati zdravstveno osebje (glejte poglavje 6.6).
English: The usual starting dose of Bortezomib Accord is 1.3 mg/m2 body surface area twice a week.
Slovenian: Običajni začetni odmerek zdravila Bortezomib Accord je 1,3 mg/m2 telesne površine dvakrat na teden.
English: 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.
Slovenian: Melfalan (9 mg/m2) in prednizolon 60 mg/m2) se dajeta peroralno na 1., 2., 3., in 4. dan prvega tedna vsakega kroga zdravljenja.
English: If you have mantle cell lymphoma and are given the medicine rituximab with Bortezomib Accord you should tell your doctor:
Slovenian: Če imate limfom plaščnih celic in prejemate rituksimab skupaj z zdravilom Bortezomib Accord, zdravniku povejte če:
English: NA=not applicable, NE=not estimated
Slovenian: NOS (not otherwise specified) = ni drugače določeno
English: What Bortezomib Accord is and what it is used for
Slovenian: Kaj je zdravilo Bortezomib Accord in za kaj ga uporabljamo
English: CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-valued
Slovenian: CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-vrednostd
English: 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.
Slovenian: 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.
English: Dose adjustments during treatment and re-initiation of treatment for monotherapy
Slovenian: Prilagoditev odmerjanja med zdravljenjem in pri ponovni uvedbi zdravljenja v obliki monoterapije
English: 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.
Slovenian: 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%.
English: Note: An OR > 1 indicates an advantage for Bz-containing induction therapy.
Slovenian: Opomba: OR > 1 kaže na prednost uvajalnega zdravljenja z Bz.
English: Bortezomib Accord therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Slovenian: Zdravljenje z zdravilom Bortezomib Accord je treba prekiniti dokler se simptomi toksičnosti ne povrnejo na 2. stopnjo ali še izboljšajo.
English: The other ingredient is mannitol (E421).
Slovenian: Pomožna snov je manitol (E421).
English: N=130 (ITT population)
Slovenian: n=130 (ITT populacija)
English: 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
Slovenian: Kaj je zdravilo Bortezomib Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Bortezomib Accord Kako uporabljati zdravilo Bortezomib Accord
English: Bortezomib Accord is for single use only.
Slovenian: Zdravilo Bortezomib Accord je samo za enkratno uporabo.
English: 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%).
Slovenian: 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 %).
English: 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%]).
Slovenian: 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 %]).
English: ORe (95% CI)=1.688 (1.148; 2.481) p-valueg=0.007
Slovenian: ORe (95% CI)=1,688 (1,148; 2,481) p-vrednostg=0,007
English: Dex n=336a Bz n=132a
Slovenian: Bz n=333a n=336a Bz n=132a
English: Once weekly Bortezomib Accord (cycles 5-9)
Slovenian: Odmerjanje zdravila Bortezomib Accord enkrat na teden (krogi 5-9)
English: 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
Slovenian: 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
English: Orthostatic/postural hypotension was not acutely related to bolus infusion of bortezomib.
Slovenian: Ortostatska oz. posturalna hipotenzija ni bila akutno povezana z infuzijo bortezomiba.
English: 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.
Slovenian: 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
English: (usually on the legs) to large bruise-like patches under the skin or tissue
Slovenian: (najpogosteje na nogah) do velikimi, modricam podobnimi podkožnimi ali tkivnimi lisami • nerakave ciste
English: 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.
Slovenian: Melfalan in prednizolon je treba dati peroralno na 1., 2., 3. in 4. dan v prvem tednu vsakega kroga zdravljenja z zdravilom Bortezomib Accord.
English: 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).
Slovenian: 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).
English: N=127 (ITT population)
Slovenian: n=127 (ITT populacija)
English: Overall complete response (CR+CRu)f n(%)
Slovenian: Celokupen popolni odgovor (CR+CRu)f n(%)
English: * Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
Slovenian: * na osnovi prilagoditev odmerjanja v študijah faze II in III pri bolnikih z diseminiranim plazmocitomom in izkušenj v obdobju trženja.
English: Table 16: Efficacy results from study LYM-3002
Slovenian: Preglednica 15: Rezultati učinkovitosti zdravila v študiji LYM-3002 Učinkovitost
English: 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).
Slovenian: 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).
English: Progression free survival (IRC)a Events n (%)
Slovenian: Preživetje brez napredovanja bolezni (IRC)a dogodki n (%)
English: Bortezomib Accord powder for solution for injection is a white to off-white cake or powder.
Slovenian: Bortezomib Accord je prašek za raztopino za injiciranje je bela do belkasta pogača ali prašek.
English: Reduce Bortezomib Accord to 1.0 mg/m2
Slovenian: zmanjšajte odmerek zdravila Bortezomib Accord na 1,0 mg/m2
English: 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.
Slovenian: 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.
English: Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib Accord
Slovenian: Ne-hematološka toksičnost stopnje ≥ 3 povezana z uporabo zdravila Bortezomib Accord
English: Powder for solution for injection 3.5 mg/vial
Slovenian: prašek za raztopino za injiciranje 3,5 mg/vialo
English: * Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by
Slovenian: * primarna ocena učinkovitosti a OR za stopnje odziva na osnovi Mantel-Haenszelove ocene razmerja verjetnosti za stratificirane preglednice; p-vrednosti
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: • Sensitivity to light
Slovenian: • izbuljene oči • občutljivost na svetlobo
English: • different reconstitution requirements for Bortezomib Accord 3.5 mg intravenous or subcutaneous use
Slovenian: • Različne zahteve za rekonstitucijo zdravila Bortezomib Accord 3,5 mg pri intravenski ali subkutani uporabi.
English: Other medicines and Bortezomib Accord
Slovenian: Druga zdravila in zdravilo Bortezomib Accord
English: 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).
Slovenian: 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).
English: In the BzR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Slovenian: V skupini BzR-CAP je prejelo infuzijo trombocitov 22,5 % bolnikov, v skupini R-CHOP pa 2,9 % bolnikov.
English: Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone
Slovenian: Prilagajanje odmerka med zdravljenjem in ob ponovni uvedbi kombiniranega zdravljenja z melfalanom in prednizolonom
English: Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib.
Slovenian: pri katerih se pojavi ortostatska hipotenzija ob bortezomibu (intravensko), niso imeli nobenih znakov ortostatske hipotenzije pred zdravljenjem z bortezomibom.
English: For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics.
Slovenian: Za dodatne informacije o melfalanu in prednizolonu, glejte ustrezna Povzetka glavnih značilnosti zdravila.
English: • advice on how to reduce the risk of mix-up of intravenous and subcutaneous reconstituted syringes
Slovenian: • Navodilo kako lahko zmanjšamo možnost zamenjave injekcijskih brizg za intravensko in subkutano injiciranje.
English: 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).
Slovenian: 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).
English: WESSLING Hungary Kft. Anonymus u. 6., Budapest, 1045, Hungary
Slovenian: WESSLING Hungary Kft. Anonymus u. 6., Budapest, 1045, Madžarska
English: 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).
Slovenian: 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%).
English: When toxicity resolves re-initiate Bortezomib Accord treatment and reduce dose to 0.7 mg/m2 once per week.
Slovenian: Nato ponovno uvedite zdravljenje z zdravilom Bortezomib Accord in zmanjšajte odmerek na 0,7 mg/m2 enkrat na teden.
English: g P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
Slovenian: g vrednost p iz Cochran Mantel-Haenszelovega hi-kvadrat testa, skupaj s stratifikacijskima dejavnikoma IPI tveganjem in stopnjo bolezni.
English: Powder for solution for injection 1 mg/vial
Slovenian: prašek za raztopino za injiciranje 1 mg/vialo
English: In study IFM-2005-01 bortezomib combined with dexamethasone [BzDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
Slovenian: V študiji IFM-2005-01 so primerjali kombinacijo bortezomiba in deksametazona [BzDx, n=240] s kombinacijo vinkristin-doksorubicin-deksametazon BzDx, n=242].
English: • ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Slovenian: Hematološka toksičnost • nevtropenija z zvečano telesno temperaturo stopnje ≥ 3, nevtropenija 4. stopnje, ki traja več kot 7 dni, število trombocitov < 10.000 celic/μl
English: ORR (CR+PR) p-valuea CR n (%) PR n (%) nCR n (%)
Slovenian: ORR (CR+PR) p-vrednosta CR n (%) PR n (%) nCR n (%)
English: MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA ZA PROMET
English: Response Rate at 4 cycles n (%)
Slovenian: Stopnja odziva v 4. krogu n (%)
English: 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.
Slovenian: 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.
English: Table 6: Recommended starting dose modification for Bortezomib Accord in patients with hepatic impairment
Slovenian: Preglednica 6: Priporočena prilagoditev začetnega odmerka zdravila Bortezomib Accord pri bolnikih z boleznijo jeter
English: Bortezomib Accord is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Slovenian: Zdravilo Bortezomib Accord dajte subkutano v stegno (desno ali levo) ali trebuh (desno ali levo).
English: Your doctor will work out your dose of Bortezomib Accord according to your height and weight (body surface area).
Slovenian: Zdravnik bo določil odmerek na osnovi vaše telesne višine in mase (telesne površine).
English: • If several Bortezomib Accord doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Slovenian: Bortezomib Accord v enem krogu zdravljenja (≥ 3 odmerke pri odmerjanju dvakrat na teden ali ≥ 2 odmerka pri odmerjanju enkrat na teden)
English: Time to progression
Slovenian: Čas do odziva
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzR-CAP arm.
Slovenian: V BzR-CAP kraku študije je protivirusna zdravila prejelo 137 od 240 bolnikov (57%).
English: Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/µl were excluded.
Slovenian: bolniki, ki so imeli na začetku študije stopnjo periferne nevropatije ≥ 2 ali število trombocitov <50,000/µl, so bili izključeni.
English: Response Rate at 8 cycles n (%)
Slovenian: Stopnja odziva v 8. krogu n (%)
English: You may also be given Bortezomib Accord together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Slovenian: Lahko pa boste zdravilo Bortezomib Accord prejeli skupaj z zdraviloma pegilirani liposomski doksorubicin ali deksametazon.
English: Change Bortezomib Accord treatment schedule to 1.3 mg/m2 once per week
Slovenian: ali spremenite shemo zdravljenja z zdravilom Bortezomib Accord na odmerek 1,3 mg/m2 enkrat na teden
English: An effective reinduction multiagent chemotherapy regimen was administered in 3 blocks.
Slovenian: Bolnikom so ponovno uvedli učinkovito indukcijsko kemoterapijo z več zdravili v 3 sklopih.
English: d Based on Log rank test stratified with IPI risk and stage of disease.
Slovenian: d Na osnovi Log rank testa, stratificiranega z IPI tveganjem in stopnjo bolezni.
English: • 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
Slovenian: • 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
English: Events (deaths) n (%) Mediana
Slovenian: dogodki (smrti) n (%)
English: A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone group.
Slovenian: Opazili so statistično značilno razliko v Cr+nCR v prid skupine, ki je prejemala bortezomib in deksametazon.
English: 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:
Slovenian: Če prejemate zdravilo Bortezomib Accord skupaj z drugimi zdravili za zdravljenje limfoma plaščnih celic, se lahko pri vas pojavijo naslednji neželeni učinki:
English: In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BzTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
Slovenian: 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].
English: Be sure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Slovenian: Na viali preverite koncentracijo, da zagotovite pravilni odmerek za intravensko dajanje zdravila (1 mg/ml).
English: Bortezomib Accord is administered via intravenous or subcutaneous injection in combination with oral melphalan and oral prednisone as shown in Table 2.
Slovenian: 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.
English: 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).
Slovenian: 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).