FrancophonIA/ELRC3.0 huggingface dataset:
English: 16 patients with MCD treated with 11 mg/kg every 3 weeks, overall tumour response rate by independent review was 43.8% with 6.3% complete response.
Slovenian: Pri 16 bolnikih z MCD, ki so prejemali odmerek 11 mg/kg vsake 3 tedne, je bila po oceni neodvisnih ocenjevalcev pogostnost celokupnega odziva 43,8%, popolnega odziva pa 6,3%.
English: • you have a condition such as stomach ulcer or diverticulitis that may increase the risk of getting a tear in the stomach or gut (gastrointestinal perforation).
Slovenian: • če imate bolezen, kot je rana na želodcu ali vnetje sigmoidnega dela debelega črevesja (divertikulitis), ki lahko poveča nevarnost za nastanek raztrganine želodca ali črevesja (gastrointestinalna perforacija).
English: • You must not become pregnant while you are being treated with SYLVANT and for 3 months after your treatment has finished.
Slovenian: • Med zdravljenjem z zdravilom SYLVANT in še 3 mesece po zaključku zdravljenja ne smete zanositi.
English: Following the single dose administration at the recommended dose regimen (11 mg/kg given once every 3 weeks), the clearance was 3.54 ± 0.44 mL/kg/day and half-life was 16.3 ± 4.2 days.
Slovenian: Po enkratnem odmerku (11 mg/kg enkrat na 3 tedne, skladno s priporočenim režimom odmerjanja) je bil očistek 3,54 ± 0,44 ml/kg/dan, razpolovni čas izločanja pa 16,3 ± 4,2 dneva.
English: In Study 1 a statistically significant difference in independently reviewed durable tumour and symptomatic response rate in the siltuximab arm compared with the placebo arm (34% vs. 0%, respectively; 95% CI: 11.1, 54.8; p = 0.0012) was observed.
Slovenian: V študiji 1 so opazili statistično značilno razliko neodvisno ocenjenega trajnega tumorskega in simptomatskega odziva medskupinama s siltuksimabom in placebom (34% v primerjavi z 0%, 95%: 11,1, 54,8; p = 0,0012).
English: If the patient develops a severe infusion related reaction, anaphylaxis, severe allergic reaction, or cytokine release syndrome related to the infusion, further administration of SYLVANT should be discontinued.
Slovenian: Če se pri bolniku zaradi infuzije razvije huda infuzijska reakcija, anafilaksija, huda alergijska reakcija ali sindrom sproščanja citokinov, je treba infundiranje zdravila SYLVANT prekiniti.
English: As with other immunoglobulin G antibodies, siltuximab crosses the placenta as observed in studies in monkeys.
Slovenian: Tako kot drugi imunoglobulini G (protitelesa IgG) tudi siltuksimab prehaja preko placente, kar so opazili v raziskavah na opicah.
English: • warfarin, a blood thinner
Slovenian: • varfarin, zdravilo za redčenje krvi
English: Measurement of IL-6 concentrations in serum or plasma during treatment should not be used as a pharmacodynamic marker, as siltuximab-neutralised antibody-IL-6 complexes interfere with current immunological-based IL-6 quantification methods.
Slovenian: Meritev koncentracije IL-6 v serumu oziroma plazmi se ne sme uporabljati kot kazalec farmakodinamike zdravila, saj s siltuksimabom nevtralizirani kompleksi protitelesa in IL-6 motijo imunološke metode za kvantifikacijo IL-6, ki so trenutno na voljo.
English: The overall tumour response rate was evaluated based on modified Cheson criteria both by independent review and investigator assessment.
Slovenian: Delež bolnikov s celokupnim tumorskim odzivom so tako neodvisni ocenjevalci kot raziskovalci v študiji ocenjevali po modificiranih Chesonovih kriterijih.
English: No case of overdose has been reported in clinical trials.
Slovenian: V kliničnih študijah niso poročali o primerih prevelikega odmerjanja.
English: Upon resolution of the reaction, reinitiating the infusion at a lower infusion rate and therapeutic administration of antihistamines, acetaminophen, and corticosteroids may be considered.
Slovenian: Ko reakcija izzveni, lahko razmislite o ponovni uvedbi infuzije z manjšo hitrostjo in dodajanju antihistaminikov, paracetamola in kortikosteroidov.
English: SYLVANT is used to treat multicentric Castleman's disease (MCD) in adult patients who do not have human immunodeficiency virus (HIV) or human herpesvirus-8 (HHV-8) infection.
Slovenian: Zdravilo SYLVANT uporabljamo za zdravljenje multicentrične Castlemanove bolezni pri odraslih bolnikih, ki niso okuženi z virusom humane imunske pomanjkljivosti (virusom HIV) ali s humanim herpesvirusom-8 (virusom HHV-8).
English: SYLVANT will be given to you by your doctor or nurse, in a hospital or clinic only.
Slovenian: Zdravilo SYLVANT lahko prejmete samo v bolnišnici ali ambulanti, dajala vam ga bosta zdravnik ali medicinska sestra.
English: • high level of 'uric acid' in the blood, which may cause gout
Slovenian: • visoke koncentracije sečne kisline v krvi, ki lahko povzročijo putiko
English: • abnormal kidney function test
Slovenian: • nenormalne vrednosti testov za oceno delovanja ledvic
English: * Best Supportive Care a Adjusted for corticosteroid use at randomisation b At the time of primary analysis data for 19 of 20 tumour and symptomatic responders were censored due to on-going response c N/A = “Not applicable”, there were no responders in the placebo arm, therefore, duration is not applicable d Complete symptomatic response is defined as a 100% reduction in the baseline MCD overall symptom score sustained for at least 18 weeks prior to treatment failure e Data from 11 of 13 complete symptomatic responders were censored due to on-going response
Slovenian: * najboljša podporna oskrba (BSC - Best Supportive Care)a vrednost prilagojena na uporabo kortikosteroidov ob randomizaciji b pri primarni analizi so bili cenzurirani podatki 19 od 20 bolnikov z odzivom tumorja in simptomov, ker odgovor še traja c N/A = »navedba smiselno ni potrebna«: v skupini s placebom ni bilo nobenega bolnika z odzivom, tako da navedba trajanja odziva ni smiselna d popolni odziv simptomov je opredeljen kot 100-odstotno zmanjšanje od izhodiščne vrednosti skupne ocene vseh simptomov MCD, ki traja najmanj 18 tednov, preden pride do znakov neuspeha zdravljenja e podatki 11 od 13 bolnikov s popolnim odzivom simptomov so bili cenzurirani, ker odziv še traja
English: Haemoglobin response was defined as a change from baseline of ≥ 15 g/L (0.9 mmol/L) at Week 13.
Slovenian: Hemoglobinski odziv je bil opredeljen kot sprememba od izhodiščne vrednosti za ≥ 15 g/l (0,9 mmol/l) po 13 tednih zdravljenja.
English: a SYLVANT may increase haemoglobin levels in MCD patients
Slovenian: a zdravilo SYLVANT lahko poveča koncentracijo hemoglobina pri bolnikih z MCD
English: • SYLVANT is supplied as a glass vial containing a white powder for concentrate for solution for infusion (powder for concentrate).
Slovenian: • Zdravilo SYLVANT je na voljo v stekleni viali, ki vsebuje bel prašek za pripravo koncentrata za raztopino za infundiranje (prašek za koncentrat).
English: Siltuximab is a monoclonal antibody (a specialised type of protein) that binds selectively to an antigen (a target protein) in the body called interleukin-6 (IL-6).
Slovenian: Siltuksimab je monoklonsko protitelo (posebna beljakovina), ki se v telesu selektivno veže na antigen (tarčna beljakovina) imenovan interlevkin-6 (IL-6).
English: • you have liver disease or changes that show up in blood tests of the liver.
Slovenian: • če imate bolezen jeter ali spremembe v krvnih testih jetrne fukcije.
English: The following side effects may happen with this medicine.
Slovenian: Pri uporabi tega zdravila lahko se lahko pojavijo naslednji neželeni učinki.
English: Do not use if you see opaque or foreign particles and/or if the solution appears discoloured after reconstitution.
Slovenian: Ne uporabljajte, če je raztopina motna ali v njej plavajo tuji delci in/ali če se je po rekonstituciji raztopina obarvala.
English: Best tumour response (investigator assessment)
Slovenian: najboljši tumorski odziv (po oceni raziskovalcev)
English: Hypoglobulinaemia was observed in 4 to 11.3% of patients in the clinical study.
Slovenian: Pri 4-11,3% bolnikov v klinični študiji so opazili hemoglobinemijo.
English: • SYLVANT is not recommended for use during pregnancy.
Slovenian: • Uporaba zdravila SYLVANT v nosečnosti ni priporočljiva.
English: Decreases in total IgG, IgA, or IgM levels below normal were observed in the range of 4 to 11%
Slovenian: V študiji MCD (študija 1) so opazili zmanjšanja v celokupnih vrednostih IgG, IgA ali IgM v razponu od 4 do 11%.
English: Multicentric Castleman's disease causes benign tumours (non-cancerous growths) to develop in the lymph nodes in the body.
Slovenian: Multicentrična Castlemanova bolezen povzroči, da se v bezgavkah po telesu razvijejo benigni tumorji (nerakaste tvorbe).
English: Consequently, infants born to women treated with siltuximab may be at increased risk of infection, and caution is advised in the administration of live vaccines to these infants (see section 4.4).
Slovenian: To bi lahko pri dojenčkih žensk, ki so prejemale siltuksimab, povečalo tveganje za okužbe, zato je pri teh dojenčkih potrebna previdnost pri cepljenju z živimi cepivi (glejte poglavje 4.4).
English: Select efficacy results from Study 1 in the hyaline vascular subgroup are summarised in Table 4.
Slovenian: Izbrani rezultati o učinkovitosti v podskupini s hialino vaskularnim histološkim podtipom iz študije 1 so povzeti v preglednici 4.
English: Siltuximab must be administered as an intravenous infusion.
Slovenian: Siltuksimab se daje z intravensko infuzijo.
English: Intravenous infusion after reconstitution and dilution.
Slovenian: Za intravensko infundiranje po rekonstituciji in redčenju.
English: The repeat-dose toxicology studies conducted in young cynomolgus monkeys at doses of 9.2 and 46 mg/kg/week (up to 22-fold greater exposure than in patients receiving 11 mg/kg every 3 weeks) with siltuximab showed no signs indicative of toxicity.
Slovenian: Študije toksičnosti pri večkratnem odmerjanju siltuksimaba, pri mladih opicah cinomolgus pri odmerkih 9,2 in 46 mg/kg/teden (do 22-krat večja izpostavljenost, kot pri bolnikih, ki prejemajo 11 mg/kg vsake 3 tedne) niso pokazale znakov toksičnosti.
English: Siltuximab is a human-mouse chimeric monoclonal antibody that forms high affinity, stable complexes with soluble bioactive forms of human IL-6.
Slovenian: Siltuksimab je človeško-glodalsko himerno monoklonsko protitelo, ki z visoko afiniteto tvori stabilne komplekse s topno, biološko aktivno obliko človeškega IL-6.
English: Histological subtype was similar in both treatment arms, with 33% hyaline vascular subtype, 23% plasmacytic subtype and 44% mixed subtype.
Slovenian: hialino vaskularnega podtipa, 23% plazmacitnega podtipa in 44% mešanega podtipa.
English: Following treatment with SYLVANT in clinical trials, transient or intermittent mild-to-moderate elevation of hepatic transaminase levels or other liver function tests such as bilirubin have been reported.
Slovenian: Med zdravljenjem z zdravilom Sylvant v kliničnih preskušanjih so poročali o prehodnem ali občasnem blagem do zmernem zvečanju jetrnih transaminaz ali drugih izvidov delovanja jeter kot je npr. koncentracija bilirubina.
English: There are no data from the use of siltuximab in pregnant women.
Slovenian: O uporabi siltuksimaba pri nosečnicah ni podatkov.
English: Siltuximab+BSC* Placebo+BSC 95% CIa
Slovenian: Cilji opazovanja za oceno učinkovitosti siltuximab+BSC* placebo+BSC 95% IZa
English: The MAH should provide tabulated data to the CHMP every 12 months in line with the periodic safety update report (PSUR) cycle including data for only those patients who are candidates for treatment with siltuximab.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora vsakih 12 mesecev (skladno z datumom predložitve Redno posodobljenega poročila o varnosti zdravila (PSUR)) CHMP predložiti podatke (v obliki preglednic), vključno s podatki o bolnikih, ki so primerni za zdravljenje z zdravilom Sylvant.
English: • During the infusion with SYLVANT, you will be monitored for side effects.
Slovenian: • Med infundiranjem zdravila SYLVANT vas bodo opazovali zaradi morebitnih neželenih učinkov.
English: * Best Supportive Care a 95% confidence interval for the for the difference in proportions b N/A = “Not applicable”, there were no responders therefore 95% CI is not applicable c 95% confidence interval for the hazard ratio d Complete symptomatic response is defined as a 100% reduction in the baseline MCD overall symptom score sustained for at least 18 weeks prior to treatment failure
Slovenian: a 95% interval zaupanja razlike med razmerji b N/A = »navedba smiselno ni potrebna« v tej skupini ni bilo nobenega bolnika z odzivom, zato navedba 95% IZ ni smiselna c 95% % interval zaupanja razmerja tveganj d popolni simptomatski odziv je opredeljen kot 100-odstotno zmanjšanje od izhodiščne vrednosti skupne ocene vseh simptomov MCD, ki traja najmanj 18 tednov, preden pride do znakov neuspeha zdravljenja
English: Complete symptom response was defined as a 100% reduction from the baseline overall in the MCD-related overall symptom score sustained for at least 18 weeks prior to treatment failure.
Slovenian: Popolni simptomatski odziv je bil opredeljen kot 100% zmanjšanje od izhodiščne vrednosti skupne ocene vseh simptomov multicentrične Castlemanove bolezni, ki traja najmanj 18 tednov, preden pride do znakov neuspeha zdravljenja.
English: Siltuximab is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Uporaba siltuksimaba ni priporočljiva pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije in med nosečnostjo.
English: The primary endpoint of the study was durable tumour and symptomatic response, defined as tumour response assessed by independent review and complete resolution or stabilisation of prospectively collected MCD symptoms, for at least 18 weeks without treatment failure.
Slovenian: Primarni cilj opazovanja v študiji je bil trajen tumorski in simptomatski odziv, opredeljen kot odziv tumorja, kot so ga ocenili neodvisni ocenjevalci, in pomeni izginotje ali stabilizacijo vseh prospektivno nakopičenih simptomov multicentrične Castlemanove bolezni, če odziv traja najmanj 18 tednov brez znakov neuspeha zdravljenja.
English: For patients who do not tolerate the infusion following these interventions, SYLVANT should be discontinued.
Slovenian: Pri bolnikih, ki kljub navedenim ukrepom ne prenašajo infuzije, je treba zdravljenje z zdravilom SYLVANT prekiniti.
English: The highest total amount of siltuximab administered in any clinical trial so far per dose was 2,190 mg (11 mg/kg).
Slovenian: Največji skupni odmerek v kliničnih študijah D sedaj je bila največja količina siltuksimaba dana v kateri koli študiji 2.190 mg (11 mg/kg) na odmerek.
English: What SYLVANT is and what it is used for What SYLVANT is
Slovenian: Kaj je zdravilo SYLVANT in za kaj ga uporabljamo Kaj je zdravilo SYLVANT
English: How SYLVANT works
Slovenian: Kako zdravilo SYLVANT deluje
English: Siltuximab+BSC* Placebo+BSC P-valuea
Slovenian: placebo+ BSC
English: • The reconstituted solution should be kept for no more than 2 hours prior to addition into the intravenous bag.
Slovenian: • Rekonstituirana raztopina lahko čaka največ 2 uri, preden jo dodate v infuzijsko vrečko.
English: • Calculate the dose, total volume of reconstituted SYLVANT solution required and the number of vials needed.
Slovenian: • Izračunajte potrebni odmerek, volumen rekonstituirane raztopine zdravila SYLVANT, in število vial.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you are given SYLVANT.
Slovenian: Če karkoli od zgoraj navedenega velja za vas (ali o tem niste prepričani), se posvetujte z zdravnikom ali farmacevtom, preden prejmete zdravilo SYLVANT.
English: It is unknown whether siltuximab is excreted in human milk.
Slovenian: Ni znano, ali se siltuksimab izloča v materino mleko.
English: In clinical studies, siltuximab was associated with an infusion related reaction or hypersensitivity reaction in 5.1% (severe reaction in 0.8%) of patients treated with siltuximab monotherapy.
Slovenian: Infuzijske reakcije in preobčutljivost V kliničnih študijah je bil siltuksimab povezan z infuzijsko reakcijo ali preobčutljivostjo pri 5,1% (s hudo obliko pri 0,8%) bolnikov, ki so prejemali siltuksimab v monoterapiji.
English: 30/11/2015 (aligned with expected PSUR cycle)
Slovenian: Prva predložitev podatkov: 30/11/2015 (skladno s časom predložitve PSUR)
English: In this study, 16 of the 35 MCD patients were hyaline vascular subtype; 31% of these patients had a radiologic response based on independent review and 88% showed clinical benefit response as defined in the protocol.
Slovenian: 31% teh bolnikov je (po oceni neodvisnih ocenjevalcev) imelo radiološki odziv in pri 88% je prišlo do kliničnega odgovora (kot je bil določen v načrtu raziskave).
English: Consistent with half-life after the first dose, serum concentrations reached steady-state levels by the sixth infusion (intervals every 3 weeks) with mean (± SD) peak and trough concentrations of 332 ± 139 and 84 ± 66 mcg/mL, respectively.
Slovenian: V skladu z razpolovnim časom izločanja po prvem odmerku jekoncentracija v serumu dosegla stanje dinamičnega ravnovesja po šesti infuziji (pri odmerjanju vsake 3 tedne), pri čemer je bila povprečna najvišja koncentracija (± standardna deviacija) 332 ± 139 μg/ml, najmanjša koncentracija pred naslednjim odmerjanjem pa 84 ± 66 μg/ml.
English: Table 4: Select efficacy endpoints for hyaline vascular subgroup from study 1 Efficacy endpoints
Slovenian: Preglednica 4: Izbrani rezultati o učinkovitosti v podskupini s hialino vaskularnim histološkim podtipom iz študije 1
English: IL-6 to both soluble and membrane-bound IL-6 receptors (IL-6R), thus inhibiting the formation of the hexameric signaling complex with gp130 on the cell surface.
Slovenian: Siltuksimab preprečuje vezavo človeškega IL-6 tako na topne kot na membransko vezane receptorje za IL-6 (IL-6R) in s tem zavira tvorbo heksamernega signalnega kompleksa z glikoproteinom130 na celični površini.
English: Calculate the dose, total volume of reconstituted SYLVANT solution required and the number of vials needed.
Slovenian: Izračunajte potrebni odmerek, volumen rekonstituirane raztopine zdravila SYLVANT, in število vial.
English: In long-term treatment of MCD patients with siltuximab at the recommended dosage of 11 mg/kg every 3 weeks, infusion related reactions or hypersensitivity reactions occurred at a frequency of 6.3% (1.3% for severe reactions).
Slovenian: Med dolgotrajnim zdravljenjem bolnikov multicentrično Castlemanovo boleznijo v priporočenem odmerku 11 mg/kg vsake 3 tedne je bila pogostnost infuzijskih reakcij ali preobčutljivost 6,3% (1,3%
English: What SYLVANT looks like and contents of the pack
Slovenian: Izgled zdravila SYLVANT in vsebina pakiranja
English: Paediatric population The safety and efficacy of siltuximab have not been established in paediatric patients.
Slovenian: Varnost in učinkovitost siltuksimaba pri pediatričnih bolnikih nista bili dokazani.
English: Upon initation or discontinuation of siltuximab in patients being treated with concomitant medicinal products that are CYP450 substrates and have a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or concentration of medicinal product (e.g., cyclosporine or theophylline) is recommended.
Slovenian: Pri bolnikih, ki sočasno prejemajo zdravilo, ki je substrat CYP450 z majhnim terapevtskim indeksom, je ob začetku ali prekinitvi uporabe zdravila SYLVANT priporočljivo spremljanje učinka (npr. pri varfarinu) ali koncentracije zdravila (npr. ciklosporina ali teofilina).
English: Before administering the infusion, the prescriber should consider delaying treatment, if the treatment criteria outlined in Table 1 are not met.
Slovenian: Če pred infundiranjem bolnik ne izpolnjuje kriterijev za zdravljenje, navedenih v preglednici 1, je treba razmisliti o odložitvi zdravljenja.
English: • respiratory infections - such as of the nose, sinuses or throat
Slovenian: • okužbe dihal - nosu, sinusov, žrela ali grla • okužba sečil
English: • Allow vial(s) of SYLVANT to come to room temperature (15°C to 25°C) over approximately 30 minutes.
Slovenian: • Viale z zdravilom SYLVANT pustite pri sobni temberaturi (15°C-20°C) približno 30 minut, da se segrejejo.
English: During an embryo-fetal development study where siltuximab was administered intravenously to pregnant cynomolgus monkeys (gestation day 20 - 118) at doses of 9.2 and 46 mg/kg/week, no maternal or fetal toxicity was observed.
Slovenian: V študiji embriofetanega razvoja, v kateri so brejim opicam cinomolgus (od 20. do 118. dne brejosti) intravensko injicirali siltuksimab v odmerkih 9,2 oziroma 46 mg/kg/teden, niso opazili toksičnih učinkov na mater ali na plod.
English: Available non-clinical data do not suggest an effect on fertility under siltuximab treatment (see section 5.3).
Slovenian: Razpoložljivi predklinični podatki ne kažejo, da bi zdravljenje s siltuksimabom vplivalo na plodnost (glejte poglavje 5.3).
English: Patients with MCD produce too much IL-6 and this is thought to contribute to the abnormal growth of certain cells in lymph nodes.
Slovenian: Pri bolnikih z multicentrično Castelmanovo boleznijo v telesu nastaja preveč IL-6, kar naj bi prispevalo k nenormalni rasti določenih celicah v bezgavkah.
English: 432 patients were available for anti-siltuximab antibody testing with 189 patients having at least one sample tested with the high medicinal product-tolerant ECLIA assay.
Slovenian: Pri 189 bolnikih so testirali vsaj en vzorec z metodo (high medicinal product-tolerant) ECLIA.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: SYLVANT is a medicine that contains the active substance siltuximab.
Slovenian: Zdravilo SYLVANT vsebuje učinkovino siltuksimab.
English: ECOG performance status score (0/1/2) at baseline was 42%/45%/13% in the siltuximab arm and 39%/62%/0% in the placebo arm, respectively.
Slovenian: Oceno splošne zmogljivosti po lestvici ECOG (Eastern Cooperative Oncology Group) 0, 1 oziroma 2 je imelo ob izhodišču 42%, 45% oziroma 13% bolnikov v skupini s siltuksimabom in 39%, 62% oziroma 0% bolnikov v skupini s placebom.
English: Administer the diluted solution over a period of 1 hour using administration sets lined with PVC, or polyurethane (PU), or PE, containing a 0.2-micron inline polyethersulfone (PES) filter.
Slovenian: Infundiranje razredčene raztopine naj traja 1 uro, uporabiti pa morate infuzijski sistem iz PVC, poliuretana (PU) ali PE, z 0,2-mikronskim polietersulfonskim (PES) linijskim filtrom.
English: Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Huda preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
English: No formal studies have been conducted to investigate the PK of siltuximab in patients with renal or hepatic impairment (see section 4.4).
Slovenian: Formalnih študij farmakokinetičnih lastnosti siltuksimaba pri bolnikih z okvaro ledvic ali jeter niso izvedli (glejte poglavje 4.4).
English: The immunogenicity of siltuximab has been evaluated using antigen-bridging enzyme immunoassay (EIA) and electrochemiluminescence (ECL)-based immunoassay (ECLIA)
Slovenian: antigen-bridging EIA - Enzyme immunoassay) in z imunsko metodo ECLIA (Electrochemiluminescence immunoassay), ki temelji na elektrokemiluminiscenci (ECL - Electrochemiluminescence immunoassay).
English: • No physical biochemical compatibility studies have been conducted to evaluate the co-administration of SYLVANT with other medicinal products.
Slovenian: • Fizikalno-biokemijskih študij kompatibilnosti za oceno odmerjanja zdravila SYLVANT skupaj z drugimi zdravili niso izvedli.
English: severe dizziness or light-headedness, swelling of the lips or skin rash.
Slovenian: huda vrtoglavica ali omotica, otekanje ustnic ali kožni izpuščaj.
English: The effect of anti-siltuximab antibody status was not examined, as there were insufficient numbers of anti-siltuximab antibody positive patients.
Slovenian: Vpliva prisotnosti protiteles proti siltuksimabu niso preučevali, saj je bilo število bolnikov s prisotnimi protitelesi proti siltuksimabu premajhno.