FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients achieving a complete response can continue treatment for at least 2 cycles after the first evidence of complete response, even if this requires treatment for more than 8 cycles.
Slovenian: Bolniki s popolnim odgovorom lahko z zdravljenjem nadaljujejo še najmanj dva cikla po prvi ugotovitvi popolnega odgovora, tudi če to zahteva zdravljenje, daljše od 8 ciklov.
English: - The other ingredients are mannitol (E421).
Slovenian: - Druga sestavina zdravila je manitol (E421).
English: In a few cases, patients who have had hepatitis B might have a repeated attack of hepatitis, which can be fatal.
Slovenian: Pri bolnikih, ki so imeli hepatitis B, lahko bolezen ponovno izbruhne, kar je lahko v redkih primerih smrtno.
English: The educational material shall consist of the following:
Slovenian: Izobraževalno gradivo mora vsebovati:
English: Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18%] in BDx group and 52/242 [21%] in VDDx group).
Slovenian: Nanaša se na stopnjo odgovora po drugi presaditvi pri posameznikih, pri katerih je bila le-ta izvedena (42/240 [18 %] v skupini BDx in 52/242 [21 %] v skupini VDDx).
English: e Median duration of follow up is 11.8 months
Slovenian: Mediano trajanje nadaljevanja zdravljenja je 11,8 mesecev.
English: Abbreviations: SGOT=serum glutamic oxaloacetic transaminase;
Slovenian: Okrajšave: SGOT = serumska glutamat-oksaloacetat transaminaza;
English: Treatment with bortezomib can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Slovenian: Zdravljenje z bortezomibom lahko zelo pogosto povzroči zmanjšanje števila rdečih in belih krvnih celic ter krvnih ploščic.
English: Do not drive or operate tools or machines if you experience such side effects; even if you do not, you must still be cautious.
Slovenian: Če imate navedene neželene učinke ne vozite in ne upravljajte orodij ali strojev, pa tudi če jih nimate morate vseeno biti previdni.
English: Bortezomib may have a moderate influence on the ability to drive and use machines.
Slovenian: Bortezomib ima lahko zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: B=bortezomib; M=melphalan, P=prednisone
Slovenian: B = bortezomib; M = melfalan, P = prednizon
English: Detailed information on this medicinal product is available on the website of European Medicinal Agency http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of bortezomib must be considered unless the benefit of treatment clearly outweighs the risk.
Slovenian: Če toksičnost ne mine ali če se ponovi tudi pri najmanjšem odmerku, morate razmisliti o ukinitvi bortezomiba, razen če koristi zdravljenja odtehtajo s tem povezano tveganje.
English: Fresenius Kabi Oncology Plc, Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, United Kingdom
Slovenian: Fresenius Kabi Oncology Plc, Lion Court, Farnham Road, Bordon, Hampshire, GU35 0NF, Velika Britanija
English: In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora v vsaki državi članici s pristojnim nacionalnim organom dogovoriti glede oblike in vsebine izobraževalnih gradiv.
English: Patients with pre-existing severe neuropathy may be treated with bortezomib only after careful risk/benefit assessment.
Slovenian: Bolnike z obstoječo hudo nevropatijo lahko zdravite z bortezomibom šele po skrbnem pretehtanju razmerja med koristjo in tveganjem.
English: Once weekly bortezomib (cycles 5-9)
Slovenian: Odmerjanje bortezomiba enkrat na teden (cikli 5-9)
English: It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of bortezomib therapy.
Slovenian: Priporočamo tudi, da odzivni bolniki, ki ne dosežejo popolne remisije, prejmejo skupno 8 ciklov zdravljenja z bortezomibom.
English: In the BTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Slovenian: V skupini BTDx je imelo 12 % bolnikov citogenetiko velikega tveganja v primerjavi s 16 % v skupini TDx.
English: c p-value d
Slovenian: c p-vrednost d
English: • Inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots
Slovenian: • vnetje ali krvavitev iz krvnih žil, ki se lahko kaže z majhnimi rdečimi ali vijoličnimi pikami
English: When bortezomib is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Slovenian: Če jemljete bortezomib skupaj z talidomidom in deksametazonom, traja en cikel zdravljenja 28 dni (4 tedne).
English: The overall incidence of diarrhoea, gastrointestinal and abdominal pain, asthenic conditions, upper respiratory tract infections and peripheral neuropathies were 12%-15% lower in the subcutaneous group than in the intravenous group.
Slovenian: Celukupna incidenca driske, gastrointestinalne in abdominalne bolečine, asteničnih stanj, okužb zgornjih dihal in perifernih nevropatij je bila za 12 %-15 % manjša v subkutani kot v intravenski skupini.
English: At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered B+M+P treatment.
Slovenian: Ob predhodno določenem času vmesne analize je bil dosežen primarni cilj (čas do napredovanja bolezni) in bolnikom v M+P kraku študije so ponudili zdravljenje z B+M+P.
English: At 10 μM concentrations, bortezomib does not inhibit any of a wide variety of receptors and proteases screened and is more than 1,500-fold more selective for the proteasome than for its next preferable enzyme.
Slovenian: Pri koncentraciji 10 μM bortezomib ne zavira nobenega od številnih različnih pregledanih receptorjev in proteaz in je več kot 1.500-krat bolj selektiven za proteasom kot za njegov drugouvrščeni prednostni encim.
English: The total storage time for the reconstituted medicinal product should not exceed 96 hours (if stored at 25°C) and 8 days (if stored at 2-8 °C) prior to administration.
Slovenian: Skupen čas shranjevanja rekonstituiranega zdravila pred injiciranjem ne sme biti daljši od 96 ur (če se shranjuje pri 25°C) ter 8 dni (če se shranjuje pri 2-8°C).
English: Secondary endpoints included, time to progression (TTP), time to next anti-lymphoma treatment (TNT), duration of treatment free interval (TFI), overall response rate (ORR) and complete response (CR/CRu) rate, overall survival (OS) and response duration.
Slovenian: Sekundarna ocena je vključevala čas do napredovanja bolezni (TTP), čas do naslednjega zdravljenja limfoma (TNT), trajanje obdobja brez zdravljenja (TFI), celokupno stopnjo odziva (ORR) in stopnjo popolnega odziva (CR/CRu), celokupno preživetje (OS) in trajanje odziva.
English: Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy
Slovenian: Stopnja 4 (posledice, ki ogrožajo življenje; potrebno je nujno ukrepanje ) in/ali huda avtonomna nevropatija ukinite bortezomib
English: In the refractory population of the Phase II study, responses were determined by an independent review committee and the response criteria were those of the European Bone Marrow Transplant
Slovenian: Odziv na zdravljenje v populaciji bolnikov faze II preskušanja, ki so bili odporni na zdravljenje, je ugotavljala neodvisna komisija, ki je uporabila kriterije za odziv Evropske skupine za transplantacijo kostnega mozga (European Bone Marrow Transplant Group).
English: Time to response CR+PR (days)
Slovenian: Čas do odziva CR + PR (dnevi)
English: • If several bortezomib doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Slovenian: • Če preskočite več odmerkov bortezomiba v enem ciklu zdravljenja (≥ 3 odmerke pri odmerjanju dvakrat na teden ali ≥ 2 odmerka pri odmerjanju enkrat na teden)
English: Grade 1 with pain or grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
Slovenian: Stopnja 1 z bolečino ali stopnja 2 (zmerni simptomi; omejene instrumentalne osnovne vsakodnevne aktivnosti (ADL)**)
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Slovenian: Če ste prejeli večji odmerek bortezomiba, kot bi smeli To zdravilo vam bo injiciral vaš zdravnik ali medicinska sestra zato ni verjetno, da bi ga lahko prejeli preveč.
English: CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
Slovenian: CR = popolni odgovor; nCR = skoraj popolni odgovor; PR = delni odgovor; MR = minimalni odgovor
English: The usual starting dose of bortezomib is 1.3 mg/m body surface area twice a week.
Slovenian: Običajni začetni odmerek bortezomiba je 1,3 mg/m telesne površine dvakrat na teden.
English: In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and 4.4).
Slovenian: V primeru prevelikega odmerka bortezomiba je treba spremljati bolnikove vitalne znake in uvesti ustrezne podporne ukrepe za vzdrževanje krvnega tlaka (npr.: tekočine, učinkovine, ki zvišujejo krvni tlak, in/ali inotropne učinkovine) in telesne temperature (glejte poglavji 4.2 in 4.4).
English: Bortezomib should not be given by other routes.
Slovenian: Bortezomiba se ne sme dajati po nobeni drugi poti.
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/m 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 1,3 mg/m telesne površine in so vključeni v preglednico 7.
English: The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease.
Slovenian: Bolniki v obeh skupinah so na splošno imeli podobne demografske in bolezenske značilnosti: mediana starost bolnikov je bila 66 let, 74 % je bilo moških, 66 % je bilo belcev in 32 % azijcev, 69 % bolnikov je imelo pozitivno aspiracijo kostnega mozga in/ali pozitivno biopsijo kostnega mozga za MCL, 54 % bolnikov je imelo vrednost mednarodnega prognostičnega indeksa (International Prognostic Index-IPI) ≥ 3 in 76 % bolnikov je bilo v IV stadiju bolezni.
English: Overall complete response (CR+CRu)
Slovenian: Celokupen popolni odgovor (CR+CRu)
English: In addition, secondary response-related and time to event related efficacy endpoints showed consistent results for subcutaneous and intravenous administration (table 15).
Slovenian: Sekundarna stopnja odziva in čas do z dogodkom povezane učinkovitosti sta pokazali trdne rezultate za subkutano on intravensko uporabo (preglednica 15).
English: A hazard ratio < 1 indicates an advantage for BR-CAP.
Slovenian: Razmerje obetov (odds ratio-OR) > 1 predstavlja prednost za skupino BR-CAP.
English: Instructions for reconstitution Bortezomib must be reconstituted by a healthcare professional.
Slovenian: Navodila za rekonstitucijo raztopine Bortezomib mora rekonstituirati zdravstveno osebje.
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Slovenian: Periferna nevropatija ≥ 3. stopnje se je pojavila pri 6 % bolnikov v skupini s subkutanim dajanjem v primerjavi s 16 % bolnikov v skupini, ki je prejemala zdravilo intravensko (p = 0,0264).
English: Efficacy results are presented in table 16:
Slovenian: Rezultati učinkovitosti so podani v preglednici 16:
English: For subcutaneous or intravenous use after reconstitution For single use.
Slovenian: Samo za subkutano ali intravensko uporabo po rekonstituciji.
English: Patients whose levels of paraprotein continue to decrease after 8 cycles can also continue for as long as treatment is tolerated and they continue to respond.
Slovenian: Bolniki, pri katerih se koncentracija paraproteinov po 8. ciklu še znižuje, lahko z zdravljenjem nadaljujejo, dokler zdravljenje dobro prenašajo in se odzivajo nanj.
English: Do not use bortezomib - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
Slovenian: Ne uporabljajte bortezomiba - če ste alergični na bortezomib, bor ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Bortezomib mediated proteasome inhibition affects cancer cells in a number of ways, including, but not limited to, altering regulatory proteins, which control cell cycle progression and nuclear factor kappa B (NF-kB) activation.
Slovenian: Zaviranje proteasoma z bortezomibom vpliva na rakave celice na več načinov, vključno s spremembo regulatornih proteinov, ki nadzorujejo napredovanje celičnega cikla in aktivacijo nuklearnega faktorja kappa B (NF-kB).
English: 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
Slovenian: Še posebno 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 - karbamazepin, fenitoin ali fenobarbital, ki se uporabljajo za zdravljenje epilepsije - šentjanževko (Hypericum perforatum), ki se uporablja pri depresiji ali drugih stanjih - peroralne antidiabetike
English: - If, after bortezomib has been held, the toxicity does not resolve, as defined above, then bortezomib must be discontinued.
Slovenian: • Če po prekinitvi zdravljenja z bortezomibom toksičnost ne mine kot je opisano zgoraj, je treba zdravljenje z bortezomibom ukiniti.
English: Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Slovenian: Mediana starost bolnikov v študiji je bila 57 let, 55 % je bilo moških in 48 % bolnikov je imelo citogenetiko velikega tveganja.
English: Grade 2 with pain or grade 3 (severe symptoms; limiting self care ADL***)
Slovenian: Stopnja 2 z bolečino ali stopnja 3 (hudi simptomi; omejene fizične ADL***)
English: It is recommended that patients with at least partial response receive 2 additional cycles.
Slovenian: Priporočamo, da bolniki z najmanj delnim odgovorom prejmejo 2 dodatna cikla zdravljenja.
English: A statistically significant benefit (p < 0.001) in favour of the BR-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).
Slovenian: Opazili so statistično značilno korist (p < 0,001) v skupini BR-CAP v primerjavi s skupino R-CHOP za TTP (mediana 30,5 proti 16,1 mesecev), TNT (mediana 44,5 proti 24,8 mesecev) in TFI (mediana 40,6 proti 20,5 mesecev).
English: 1 year survival, % [95% CI]
Slovenian: 1-letno preživetje,% [95 % CI]
English: Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median hemoglobin of 105 g/l, and a median platelet count of 221.5 x 10
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 x 10
English: Median survival for the B+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Slovenian: Mediana preživetja v skupini B+M+P je bila 56,4 mesecev, v skupini M+P pa 43,1 mesecev.
English: The incidence of peripheral neuropathy increases early in the treatment and has been observed to peak during cycle 5.
Slovenian: Incidenca periferne nevropatije se poveča v začetku zdravljenja in doseže najvišjo vrednost v 5. ciklu zdravljenja.
English: Additional adverse drug reactions identified associated with the use of the combination therapy (BR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Slovenian: Dodatno ugotovljena neželena učinka, povezana z uporabo kombiniranega zdravljenja (BR-CAP), sta bila okužba z virusom hepatitisa B (< 1%) in ishemija miokarda (1,3 %).
English: This 21-day period (3 weeks) corresponds to one treatment cycle.
Slovenian: To 21-dnevno obdobje (3 tedne) je en cikel zdravljenja.
English: Higher incidences were also noted for infections with grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
Slovenian: Večja je bila tudi pojavnost okužb z nevtropenijo stopnje ≥ 3(24 % proti 19 % v 1. sklopu in 22 % proti 11 % v 2.sklopu), povečane koncentracije ALT (17 % proti 8 % v 2. sklopu), hipokaliemije (18 % proti 6 % v 1. sklopu in 21 % proti 12 % v 2. sklopu) in hiponatriemije (12 % proti 5 % v 1. sklopu in 4 % proti 0 v 2. sklopu).
English: There is no known specific antidote for bortezomib overdose.
Slovenian: Specifični antidot za preveliko odmerjanje bortezomiba ni znan.
English: The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Slovenian: Analiza je dokazala izboljšan ORR (CR+PR) (razmerje obetov 3,769; 95 % CI 2,045-6,947; p < 0,001), PFS (stopnja tveganja 0,511; 95% CI 0,309-0,845; p = 0,008), TTP (stopnja tveganja 0,385; 95% CI 0,212-0,698; p = 0,001) pri zdravljenju z bortezomibom v kombinaciji z deksametazonom v primerjavi z zdravljenjem z bortezomibom v monoterapiji.
English: Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m basis are associated with increases in heart rate, decreases in contractility, hypotension and death.
Slovenian: Farmakološka preskušanja kardiovaskularne varnosti zdravila pri opicah in psih kažejo povezavo med intravenskimi odmerki, ki so bili dva- do trikrat večji od priporočenega kliničnega odmerka (v mg/m in povišanjem srčne frekvence, zmanjšanjem kontraktilnosti srca, hipotenzijo in smrtjo.
English: Regardless of β2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the bortezomib arm.
Slovenian: Ne glede na koncentracijo β2-micikllobulina ob začetku zdravljenja, so se tudi vsi parametri učinkovitosti (čas do napredovanja bolezni in celokupno preživetje, kot tudi odziv na zdravljenje) v delu preskušanja z bortezomibom statistično značilno izboljšali.
English: • instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction Setting (bortezomib plus dexamethasone, and bortezomib plus dexamethasone and thalidomide).
Slovenian: • Navodila za predpisovanje in uporabo, vključno z dolžino in številom ciklov zdravljenja z namenom zmanjševanja tveganja napak pri izdajanju in uporabi zdravila, ki bi jih lahko povzročile različne kombinacije režima uvajanja bortezomiba pred transplantacijo (bortezomib v kombinaciji z deksametazonom in bortezomib v kombinaciji z deksametazonom in talidomidom).
English: The duration of overall response was 21.4 months longer in the BR-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 BR-CAP (mediana 36,5 mesecev proti 15,1 meseca v skupini R-CHOP).
English: Overall survival* Events (deaths) n (%) Median a
Slovenian: Celokupno preživetje* dogodki (smrti) n (%) Mediana a
English: The overall best response rate (CR+PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1,
Slovenian: Pri 130 bolnikih je bila celokupna stopnja odgovora (CR+PR) 38,5 % (95% CI: 30,1;
English: The following medicinal products are given on day 1 of each bortezomib 21-day treatment cycle as intravenous infusions:
Slovenian: Naslednja zdravila boste prejeli 1. dan vsakega 21-dnevnega cikla zdravljenja z bortezomibom v obliki intravenske infuzije:
English: In patients aged ≥ 75 years, both regimens, BR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Slovenian: Bolniki, stari ≥ 75 let so oba režima zdravljenja, BR-CAP in R-CHOP, slabše prenašali (glejte poglavje 4.8).
English: Other medicines and bortezomib Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katero koli drugo zdravilo.
English: The overall incidence of hepatitis B infections was similar in patients treated with BR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Slovenian: Celokupna pogostnost okužbe z virusom hepatitisa B je bila podobna pri bolnikih, zdravljenih z BR-CAP ali s R-CHOP (0,8 % v primerjavi z 1,2 %).
English: The solution should be injected subcutaneously, at 45-90° angle.
Slovenian: Raztopino morate injicirati subkutano, pod kotom 45-90 °.
English: Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib.
Slovenian: Bolniki, pri katerih se pojavi ortostatska hipotenzija ob bortezomibu (intravensko), niso imeli nobenih znakov ortostatske hipotenzije pred zdravljenjem z bortezomibom.
English: Response rate population e n=668
Slovenian: Stopnja odziva populacijae n = 668
English: (95% CI) p-value c
Slovenian: (95% CI) p-vrednost c
English: Patients who did not obtain an optimal response (less than Complete Response [CR]) to therapy with bortezomib alone after 4 cycles were allowed to receive dexamethasone 20 mg daily on the day of and after bortezomib administration.
Slovenian: Bolniki, ki niso dosegli optimalnega odgovora (manj kot popolni odgovor [CR]) na zdravljenje z bortezomibom v monoterapiji po 4 ciklih zdravljenja, so prejeli 20 mg deksametazona na dan brez zdravila in po dajanju bortezomiba.
English: Undesirable effects in table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Slovenian: Za neželene učinke, navedene v preglednici 7, so raziskovalci menili, da imajo vsaj možno do verjetno vzročno povezavo z bortezomibom.
English: Table 8: Adverse reactions in patients with mantle cell lymphoma treated with BR-CAP in a clinical trial
Slovenian: Preglednica 8: Neželeni učinki pri bolnikih z limfomom plaščnih celic, zdravljenih z BR-CAP v kliničnih preskušanjih
English: • Infection or inflammation of the stomach and intestine
Slovenian: • okužba ali vnetje trebuha in črevesja
English: Your doctor will work out your dose of bortezomib according to your height and weight (body surface area).
Slovenian: Zdravnik bo določil odmerek na osnovi vaše telesne višine in mase (telesne površine).