FrancophonIA/ELRC3.0 huggingface dataset:
English: Brain imaging, preferably Magnetic Resonance Imaging (MRI), is used to confirm the diagnosis.
Slovenian: Diagnozo potrdimo s slikovnimi preiskavami možganov, najbolje z magnetnoresonančnim slikanjem (MRI - Magnetic Resonance Imaging).
English: In the Phase III study comparing VELCADE 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).
Slovenian: V študiji faze III z zdravilom VELCADE, 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).
English: VELCADE was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Slovenian: Bolniki so prejeli zdravilo VELCADE le v 1. in 2. sklopu zdravljenja, da so izognili prekrivanju toksičnih učinkov z drugimi, sočasno danimi zdravili v 3. sklopu zdravljenja.
English: • Bulging eyes
Slovenian: • izbuljene oči
English: Although in patients aged ≥ 75 years, both VcR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the VcR-CAP groups was 68%, compared to 42% in the RCHOP group.
Slovenian: Čeprav so bolniki, stari ≥ 75 let, slabše prenašali oba režima zdravljenja, VcR-CAP in R-CHOP, je bila stopnja resnih neželenih učinkov v skupini VcR-CAP 68% v primerjavi z 42% v skupini R-CHOP.
English: The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the VELCADE 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 zdravilom VELCADE 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: • Different types of rash
Slovenian: • različne oblike izpuščaja
English: VELCADE therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better.
Slovenian: Zdravljenje z zdravilom VELCADE je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 2. stopnjo ali še izboljšajo.
English: 18.3 mo
Slovenian: 18,3 mesecev
English: Tumour lysis syndrome
Slovenian: Občasni sindrom tumorske lize
English: 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.
Slovenian: 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.
English: Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*,C-reactive protein increased
Slovenian: Občasni hiperbilirubinemija*, nenormalni izvidi analiz proteinov*, zvečana telesna masa, nenormalni izvidi krvnih preiskav*, zvišana koncentracija C-reaktivnega proteina
English: • VELCADE 3.5 mg can be administered both intravenously and subcutaneously while VELCADE 1 mg can be administered only intravenously
Slovenian: • Zdravilo VELCADE 3,5 mg se lahko daje intravensko in subkutano, zdravilo VELCADE 1 mg pa samo intravensko.
English: Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma
Slovenian: Preglednica 5: Prilagajanje odmerkov med zdravljenjem pri bolnikih s predhodno nezdravljenim limfomom plaščnih celic
English: HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-VELCADE treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP ) and 0.4% (n=1) of patients receiving VELCADE in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP).
Slovenian: Do okužbe s HBV s smrtnim izidom je prišlo pri 0,8% (n = 2) bolnikov v skupini, ki ni prejemala zdravila VELCADE (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon; skupina R-CHOP) in pri 0,4% (n = 1) bolnikov v skupini, ki je prejemala zdravilo VELCADE v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (skupina VcR-CAP).
English: Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of VELCADE (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.
Slovenian: Klinična učinkovitost pri relapsu ali diseminiranem plazmocitomu, odpornem na zdravljenje Varnost in učinkovitost zdravila VELCADE (injicirano intravensko) v priporočenem odmerku 1,3 mg/m2 so ovrednotili v dveh študijah: v randomizirani, primerjalni (primerjava z deksametazonom (Dex)) študiji 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 enodelni študiji faze II 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.
English: Neoplasm malignant, Leukaemia plasmacytic, Renal cell carcinoma, Mass, Mycosis fungoides, Neoplasm benign*
Slovenian: Redki maligne neoplazme, plazmocitna levkemija, karcinom ledvičnih celic, masa, fungoidna mikoza, benigne neoplazme
English: NOS=not otherwise specified * Grouping of more than one MedDRA preferred term.
Slovenian: NOS (not otherwise specified) = ni drugače določeno združevanje več priporočenih terminov po klasifikaciji MedDRA neželeni učinki v obdobju trženja, neodvisno od indikacije
English: • If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
Slovenian: • Če je bila v prejšnjem krogu zdravljenja opažena dolgotrajna nevtropenija 4. stopnje, trombocitopenija ali trombocitopenija in krvavitev
English: When VELCADE is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Slovenian: Če jemljete zdravilo VELCADE v kombinaciji s talidomidom, morate upoštevati program za preprečevanje nosečnosti, ki velja za talidomid (glejte navodilo za uporabo talidomida).
English: 20.7 mo
Slovenian: 20,7 mesecev
English: • Alteration of liver functioning
Slovenian: • spremembe v delovanju jeter
English: Table 15: Efficacy results from study LYM-3002
Slovenian: Preglednica 15: Rezultati učinkovitosti zdravila v študiji LYM-3002
English: Grounds for the variation to the terms of the marketing authorisation(s)
Slovenian: Podlaga za priporočilo spremembe pogojev dovoljenj(-a) za promet z zdravilom
English: It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL < 20 ml/min/1.73 m2).
Slovenian: Vpliv hude okvare ledvic na farmakokinetiko bortezomiba pri bolnikih, ki se še ne zdravijo z dializo (CrCL < 20 ml/min/1,73 m2), ni znan.
English: Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the VcR-CAP arm and with at least a possible or probable causal relationship to the components of the VcR-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 VcR-CAP in z najmanj verjetno ali možno vzročno povezanostjo s komponentami v skupini VcR-CAP.
English: • Heartburn, bloating, belching, wind, stomach pain, bleeding from your bowels or stomach
Slovenian: • zgaga, napenjanje, spahovanje, vetrovi, bolečine v trebuhu, krvavitev v črevesju ali želodcu
English: Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Slovenian: Občasni duševne motnje*, halucinacije*, psihotične motnje*, zmedenost*, nemir
English: Hazard ratio (95% CI) p-value Response rate population e n=668
Slovenian: 43,1 mesecev stopnja tveganja (95% CI) p-vrednost Stopnja odziva populacija e n = 668
English: Table 6: Recommended starting dose modification for VELCADE in patients with hepatic impairment
Slovenian: Preglednica 6: Priporočena prilagoditev začetnega odmerka zdravila VELCADE pri bolnikih z boleznijo jeter Stopnja jetrne okvare*
English: • Infection of the outermost layer of the eye and the inner surface of the eyelids (conjunctivitis)
Slovenian: • okužba veznice očesa in vek (konjuktivitis)
English: Patients should be closely monitored when given bortezomib in combination with potent CYP3A4-inhibitors.
Slovenian: Bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4 je treba skrbno spremljati.
English: • Arthritis, including inflammation of the joints in the fingers, toes, and the jaw
Slovenian: • vnetje sklepa (artritis), vključno z vnetjem sklepov prstov na roki in nogi ter čeljusti
English: For patients with a response first documented at cycle 6, two additional treatment cycles were given.
Slovenian: Bolniki, ki so dosegli odgovor šele v 6. krogu, so prejeli dva dodatna kroga zdravljenja.
English: Efficacy results are presented in Table 15:
Slovenian: Rezultati učinkovitosti so podani v preglednici 15:
English: 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.
Slovenian: Študija medsebojnega delovanja zdravil, ki je ocenjevala učinek ketokonazola, močnega inhibitorja CYP3A4, na famakokinetiko bortezomiba (danega intravensko), je na osnovi podatkov 12 bolnikov pokazala povprečen dvig AUC bortezomiba za 35% (CI90% (1.032 do 1.772)).
English: N=130 (ITT population)
Slovenian: n = 130 (ITT populacija)
English: Patients were administered intravenous doses of 0.7 to 1.3 mg/m 2 of VELCADE twice weekly.
Slovenian: Bolniki so dvakrat na teden prejemali intravenske odmerke zdravila VELCADE v odmerku od 0,7 do 1,3 mg/m2.
English: 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.
Slovenian: Kot del diferencialne diagnoze težav CŽS je treba pri bolnikih redno spremljati pojav novih ali poslabšanje nevroloških simptomov ali znakov, ki bi lahko nakazovali na PML.
English: CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat
Slovenian: CR = popolni odgovor; CRu = nepotrjen popolni odgovor; PR = delni odgovor; CI = interval zaupanja, HR = razmerje tveganja; OR = razmerje verjetnosti; ITT = populacija, ki so jo nameravali zdraviti
English: Serious adverse reactions uncommonly reported during treatment with VELCADE include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
Slovenian: Med zdravljenjem z zdravilom VELCADE 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.
English: 1.3 The reconstituted product is preservative free and should be used immediately after preparation.
Slovenian: Rekonstituirana raztopina ne vsebuje konzervansov in jo je treba porabiti takoj po raztapljanju.
English: VDDx=vincristine, doxorubicin, dexamethasone; VcDx=VELCADE, dexamethasone; TDx=thalidomide, dexamethasone; VcTDx=VELCADE, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
Slovenian: VDDx = vinkristin, doksorubicin, deksametazon; VcDx = VELCADE, deksametazon; TDx = talidomid, deksametazon; VcTDx = VELCADE, talidomid, deksametazon; PN = periferna nevropatija Opomba: periferna nevropatija vključuje priporočene termine: periferna nevropatija, periferna motorična nevropatija, periferna senzorična nevropatija, in polinevropatija.
English: 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.
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic (očistek kreatinina [CrCL] > 20 ml/min/1,73 m farmakokinetika bortezomiba ni spremenjena, zato pri njih ni potrebno prilagajati odmerka.
English: Instructions for reconstitution VELCADE must be reconstituted by a healthcare professional.
Slovenian: Navodila za rekonstitucijo raztopine Zdravilo VELCADE mora rekonstituirati zdravstveno osebje.
English: VELCADE treatment is commonly associated with orthostatic/postural hypotension.
Slovenian: Zdravljenje z zdravilom VELCADE je pogosto povezano z ortostatsko hipotenzijo oz. posturalno hipotenzijo.
English: Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough*
Slovenian: Pogosti dispneja*, epistaksa, okužba zgornjih/spodnjih dihal*, kašelj*
English: N=127 (ITT population)
Slovenian: n = 127 (ITT populacija)
English: P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
Slovenian: vrednost p iz Cochran Mantel-Haenszelovega hi-kvadrat testa, skupaj s stratifikacijskima dejavnikoma IPI tveganjem in stopnjo bolezni.
English: Uncommon Fall, Contusion Rare
Slovenian: Občasni padci, kontuzije
English: You will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.
Slovenian: Pred in med zdravljenjem z zdravilom VELCADE vam bodo redno pregledovali kri, in tako spremljali število krvnih celic.
English: Only the 3.5 mg vial can be administered subcutaneously, as described below.
Slovenian: Kot navedeno spodaj, se lahko daje subkutano le 3,5 mg viala.
English: Thalidomide dose is increased to 100 mg from week 3 of Cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
Slovenian: V 3. tednu 1. kroga se lahko odmerek talidomida poveča na 100 mg samo, če bolnik dobro prenaša odmerek 50 mg in na 200 mg v 2. krogu, če bolnik dobro prenaša odmerek 100 mg.
English: #, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection*
Slovenian: #, bakteriemija (vključno s stafilokokno), hordeol, gripa, celulitis, z uporabo katetra povezana okužba, okužba kože*, ušesne okužbe*, okužba s stafilokoki, okužbe zob*
English: This medicine is for intravenous use only.
Slovenian: To zdravilo se daje samo v veno (intravensko).
English: • Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation
Slovenian: • paraliza, krči, padci, motnje gibanja, nenormalen, spremenjen ali zmanjšan občutek (otip, sluh,
English: Platelet transfusion for the treatment of thrombocytopenia should be considered when clinically appropriate.
Slovenian: Če je klinično ustrezno je treba za zdravljenje trombocitopenije razmisliti o transfuziji trombocitov.
English: VELCADE intravenous arm
Slovenian: VELCADE intravensko VELCADE subkutano
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 VELCADE 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 velikim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/m2 na dan) skupaj z daunorubicinom in zdravilom VELCADE, umrla zaradi SARS na začetku zdravljenja in študijo so zaključili.
English: Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m
Slovenian: 375 mg/m2 rituksimaba, 750 mg/m2 ciklofosfamida in 50 mg/m2doksorubicina.
English: No new safety concerns were observed during the study, and in particular VELCADE did not exacerbate target organ damage (heart, kidney and liver).
Slovenian: Uporaba zdravila VELCADE ni povečala poškodb tarčnih organov (srce, ledvice, jetra).
English: The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were
Slovenian: Stopnja geometrične sredine AUCzadnji je bila 0,99 in 90% intervali zaupanja 80,18%-122,80%.
English: • Heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate
Slovenian: • popuščanje srca, srčni infarkt, bolečina v prsih, občutek nelagodja v prsih, pospešen ali upočasnjen srčni utrip
English: [95% CI] Best response
Slovenian: 1-letno preživetje,% [95% CI] Najboljši odziv
English: The solution will be clear and colourless, with a final pH of 4 to 7.
Slovenian: Nastala bo bistra in brezbarvna raztopina s končnim pH v območju med 4 in 7. pH raztopine ni treba preverjati.
English: 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]).
Slovenian: 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 ALL in T-celičnim limfoblastnim limfomom [LL]).
English: Table 3: Posology modifications during subsequent cycles of VELCADE therapy in combination with melphalan and prednisone
Slovenian: Preglednica 3: Prilagajanje odmerkov med kasnejšimi krogi zdravljenja z zdravilom VELCADE v kombinaciji z melfalanom in prednizonom
English: • If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL, VELCADE may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from
Slovenian: • Če toksičnost mine oz. ima bolnik ANC ≥ 750 celic/μl in število trombocitov ≥ 25.000 celic/μl, lahko ponovno uvedete zdravilo VELCADE v odmerku, ki je eno stopnjo manjši od prejšnjega(z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m2 na
English: Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances*
Slovenian: Pogosti motnje razpoloženja*, anksiozne motnje*, motnje spanja*
English: Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic
Slovenian: Občasni okužba*, bakterijske okužbe*, virusne okužbe*, sepsa (vključno s septičnim šokom)*, bronhopnevmonija, okužba s herpesvirusom*, herpetični meningoencefalitis
English: In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/l, 90% of 21 patients had a count ≤ 25,000/l during the study, including 14% < 10,000/l; in contrast, with a baseline platelet count > 75,000/l, only 14% of 309 patients had a count ≤ 25,000/l during the study.
Slovenian: Pri bolnikih, z napredujočim plazmocitomom, je bila resnost trombocitopenije povezana s številom trombocitov pred zdravljenjem (90% od 21 bolnikov, ki so imeli začetno število trombocitov < 75.000/l, je med preskušanjem imelo število trombocitov ≤ 25.000/l (vključno s 14% bolnikov, ki so imeli število trombocitov < 10.000/l).
English: 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).
Slovenian: 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).
English: The Reconstitution, dosing and administration booklet shall contain the following key elements:
Slovenian: Izobraževalna knjižica z navodili za rekonstitucijo, odmerjanje in načinom uporabe mora vsebovati naslednje ključne elemente:
English: In the Phase III study patients who received VELCADE subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of VELCADE.
Slovenian: V študiji faze III so imeli bolniki, ki so prejemali zdravilo VELCADE subkutano za 13% manjšo celokupno incidenco neželenih učinkov zaradi uporabe zdravila, s stopnjo toksičnosti 3 ali več in za 5% manjšo pogostnost prekinitve zdravljenja v primerjavi z bolniki, ki so prejemali zdravilo VELCADE intravensko.
English: OUTER CARTON, VELCADE 1 mg
Slovenian: ŠKATLA, VELCADE 1 mg
English: • Tooth infection
Slovenian: • okužba zob
English: Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis Stevens-Johnson syndrome
Slovenian: Občasni multiformni eritem, urtikarija, akutna febrilna nevtrofilna dermatoza, toksični kožni izpuščaj, toksična epidermalna nekroliza
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Vc=VELCADE; VcDx=VELCADE, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Slovenian: CI = interval zaupanja; CR = popoln odgovor; nCR = skoraj popoln odgovor; ITT = populacija, ki so jo nameravali zdraviti; RR = stopnja odgovora; Vc = VELCADE; VcDx = VELCADE in deksametazon; VDDx = vinkristin, doksorubicin in deksametazon; VGPR = zelo dober delni odgovor; PR = delni odgovor; OR = razmerje verjetnosti.
English: • A sore mouth or lip, dry mouth, mouth ulcers or throat pain
Slovenian: • vnetje ust ali ustnic, suha usta, razjede v ustih ali bolečine v grlu
English: PRES is a rare, often reversible, rapidly evolving neurological condition, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances.
Slovenian: Pri bolnikih, ki so prejemali zdravilo VELCADE so poročali o PRES. PRES je redka, pogosto reverzibilna nevrološka motnja, ki se razvije hitro in se lahko kaže z epileptičnimi napadi, hipertenzijo, glavoboli, letargijo, zmedenostjo, slepoto in drugimi motnjami vida ter nevrološkimi motnjami.