natgillin/translations-raw huggingface dataset:
A decision must be made whether to discontinue breast-feeding or discontinue/abstain from siltuximab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja s siltuksimabom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
Alternatively PE bottles may be used.
Uporablja se lahko tudi PE plastenke.
For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Za navodila o rekonstituciji in redčenju zdravila pred dajanjem glejte poglavje 6.6.
The infusion should be completed within 6 hours of the addition of the reconstituted solution to the infusion bag.
Infundiranje je treba zaključiti v roku 6 ur od dodajanja rekonstituirane raztopine v infuzijsko vrečko.
Name and address of the manufacturers of the biological active substances
Ime in naslov izdelovalcev biološke učinkovine
However, there is also evidence to suggest that IL-6 inhibition may suppress immune responses, immune surveillance and lower defense against established tumours.
Vendar pa obstoječi podatki kažejo tudi, da zaviranje IL-6 lahko zavre imunski odgovor, zmanjša imunski nadzor in obrambo proti prisotnim tumorjem.
Do not use this medicine after the expiry date which is stated on the label after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
An open-label, multicentre, non-randomised Phase 2 study assessed the safety and efficacy of extended treatment with siltuximab in 60 patients with MCD who were previously enrolled in Study 1 (41 patients) or Study 2 (19 patients).
V odprti, multicentrični, nerandomizirani študiji faze 2 so ocenjevali varnost in učinkovitost zdravljenja s siltuksimabom pri 60 bolnikih z MCD, ki so bili predhodno vključeni v študijo 1 (41 bolnikov) ali študijo 2 (19 bolnikov).
• In some cases, if you are pregnant and need treatment for MCD, your doctor may advise that the benefit of taking SYLVANT for your health outweighs the possible risks to your unborn baby, including increased risk of infection and use of certain vaccines in babies born to mothers exposed to SYLVANT while pregnant.
• Če ste noseči in je potrebno zdravljenje multicentrične Castelmanove bolezni, vam v nekaterih primerih zdravnik lahko svetuje, da prednosti zdravljenja z zdravilom SYLVANT odtehtajo tveganja za vašega nerojenega otroka, kar vključuje povečano tveganje za okužbo in tveganja uporabe določenih cepiv pri otrocih mater, ki so bile med nosečnostjo izpostavljene zdravilu
As with all therapeutic proteins, there is potential for the generation of anti-medicine antibodies (immunogenicity).
Imunogenost Kot pri vseh terapevtskih proteinih obstaja možnost za razvoj protiteles proti zdravilu (imunogenost).
• Use aseptic technique.
• Uporabljajte aseptično tehniko priprave.
Histopathological examination of lymphoid tissues from GD140 fetuses showed no morphological abnormalities in the development of the immune system.
Histopatološki pregled limfatičnega tkiva ploda na 140. dan brejosti ni pokazal morfoloških nepravilnosti v razvoju imunskega sistema.
Symptoms of this disease may include feeling tired, sweating at night, having a tingling feeling, and loss of appetite.
Simptomi te bolezni so lahko utrujenost, nočno znojenje, občutek mravljinčenja in izguba apetita.
Paediatric population No interaction studies have been performed in this population.
Pediatrična populacija Študij medsebojnega delovanja zdravil v tej populaciji niso izvedli.
IL-6 has been shown to be involved in diverse normal physiologic processes such as induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation.
Ugotovili so, da je IL-6 vpleten v različne normalne fiziološke procese, kot so indukcija sekrecije imunoglobulinov, prva stopnja sinteze proteinov akutne faze v jetrih in stimulacija proliferacije in diferenciacije prekurzorskih hematopoetskih celic.
• Any unused product or waste material should be disposed of in accordance with local requirements.
• Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
A total score of all symptoms (referred to as the MCD-related Overall Symptom Score) is the sum of the severity grades (NCI-CTCAE grade) of the MCD-related signs and symptoms [general MCD-related (fatigue, malaise, hyperhidrosis, night sweats, fever, weight loss, anorexia, tumour pain, dyspnea, and pruritus), autoimmune phenomena, fluid retention, neuropathy, and skin disorders].
Skupna ocena vseh simptomov (skupna ocena simptomov multicentrične Castlemanove bolezni po MCD-related Overall Symptom Score) je vsota vseh stopenj izraženosti (po NCI-CTCAE*) znakov in simptomov multicentrične Castlemanove bolezni [splošnih simptomov multicentrične Castlemanove bolezni (utrujenosti, splošnega slabega počutja, prekomernega znojenja, nočnega znojenja, zvišane telesne temperature, izgubljanja telesne mase, anoreksije, tumorske bolečine, dispneje in srbenja), izražanja avtoimunskih dogajanj, zastajanja tekočine, nevropatije in kožnih sprememb].
On the basis of limited experience with siltuximab the present data do not suggest any increased risk of malignancy.
Trenutni podatki (na osnovi omejenih izkušenj s siltuksimabom) ne kažejo povečanega tveganja za malignome.
If you are given more SYLVANT than you should
Če ste prejeli večji odmerek zdravila SYLVANT, kot bi smeli
Use aseptic technique.
Uporabljajte aseptično tehniko priprave.
SYLVANT may mask signs and symptoms of acute inflammation including suppression of fever and of acute-phase reactants, such as C-reactive protein (CRP).
Zdravilo SYLVANT lahko prikrije znake in simptome akutnega vnetja, vključno z zvišano telesno temperaturo in pojavljanjem beljakovin akutne faze, kot je C-reaktivni protein (CRP).
The effect of siltuximab on CYP450 enzyme activity can persist for several weeks after stopping therapy.
Učinek siltuksimaba na encimsko aktivnost CYP450 lahko traja še nekaj tednov po koncu zdravljenja.
In this study 37 patients with CD (35 MCD patients) were treated with siltuximab.
V tej študiji so s siltuksimabom zdravili 37 bolnikov s CD (o tega 35 bolnikov z MCD).
EUSA Pharma (Netherlands) B.V.
(Netherlands) B.V.
If you stop treatment with SYLVANT
Če ste prenehali uporabljati zdravilo SYLVANT
Key efficacy results from Study 1 are summarised in Table 3.
Glavni rezultati za oceno učinkovitosti iz študije 1 so navedeni v preglednici 3.
• The recommended dose is 11 milligrams per kilogram of body weight, given once every
• Priporočeni odmerek je 11 miligramov na kilogram telesne mase enkrat na 3 tedne.
Infections (including upper respiratory tract infections), pruritus, rash, arthralgia, and diarrhoea were the most common adverse reactions , occurring in > 20% of siltuximab-treated patients in Castleman's disease (CD) clinical studies.
Okužbe (vključno z okužbami zgornjih dihal), srbenje, izpuščaj, artralgija in driska so najbolj pogosti neželeni učinki v kliničnih študijah Castlemanove bolezni, ki so se pojavili pri > 20% bolnikov zdravljenih s siltuksimabom.
Contents of the pack and other information What SYLVANT contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo SYLVANT
Two cases of reactivated hepatitis B have been reported when SYLVANT was administered concomitantly with high dose dexamethasone, and bortezomib, melphalan and prednisone in multiple myeloma patients.
Poročali so o dveh primerih reaktivacije hepatitisa B, ko je bilo zdravilo SYLVANT uporabljeno sočasno z velikim odmerkom deksametazona ter bortezomibom, melfalanom in prednizolonom pri bolnikih z diseminiranim plazmocitomom.
• severe allergic reaction - the signs may include: difficulty breathing, chest tightness, wheezing,
• huda alergijska reakcija - znaki so lahko oteženo dihanje, tiščanje v prsih, piskanje v pljučih,
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Zdravnika ali farmacevta obvestite če jemljete katero od naslednjih zdravil:
• theophylline, used to treat asthma
• teofilin za zdravljenje astme
The incidence rate of detectable anti-siltuximab antibodies was 0.9% (4/432) overall and 2.1% (4/189) in patients with at least once sample tested with the high medicinal product tolerant ECLIA assay.
Celokupna pogostnost merljivih protiteles proti siltuksimabu je bila 0,9% (4/432) in 2,1% (4/189) pri bolnikih, pri katerih so testirali vsaj en vzorec z metodo ECLIA.
A Phase 2, multinational, randomised (2:1) double-blind, placebo-controlled study was conducted to assess the efficacy and safety of siltuximab (11 mg/kg every 3 weeks) compared with placebo in combination with best supportive care in patients with MCD.
Multinacionalno, randomizirano (2:1), dvojno slepo, s placebom kontrolirano študijo faze II so izvedli za oceno učinkovitosti in varnosti siltuksimaba (11 mg/kg vsake 3 tedne) v primerjavi s placebom v kombinaciji z najboljšo podporno oskrbo pri bolnikih z multicentrično Castlemanovo boleznijo.
Within the system organ class, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to
V okviru vsakega organskega sistema so neželeni učinki navedeni po pogostnosti, ki je opredeljena z naslednjima kategorijama: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥1/1.000 in <1/100); redki
The mechanism of action of siltuximab is neutralisation of IL-6 bioactivity, which can be measured indirectly by suppression of CRP.
Mehanizem delovanja siltuksimaba je nevtralizacija biološke aktivnosti IL-6, ki jo je mogoče posredno meriti z obsegom supresije CRP.
SYLVANT 100 mg powder for concentrate for solution for infusion EU/1/14/928/001
SYLVANT 100 mg prašek za koncentrat za raztopino za infundiranje EU/1/14/928/001
Pharmacotherapeutic group: Immunosuppresants, interleukin inhibitors, ATC code: L04AC11.
Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci interlevkina, oznaka ATC: L04AC11.
It is not known what the possible side effects could be from having too much SYLVANT.
Ni znano, do kakšnih neželenih učinkov bi lahko prišlo zaradi prejema prevelike količine zdravila SYLVANT.
Evidence from studies conducted with siltuximab and other IL-6 inhibitors suggest that the potential for siltuximab to cause carcinogenicity is low.
Dokazi iz študij siltuksimaba in drugih zaviralcev IL-6 kažejo ja je kancerogeni potencial siltuksimaba majhen.
Prescribers should also exercise caution when siltuximab is co-administered with medicinal products that are CYP3A4 substrates where a decrease in effectiveness would be undesirable (e.g., oral contraceptives).
Previdnost je potrebna tudi pri bolnikih, ki sočasno prejemajo siltuksimab in zdravila, ki so substrati CYP3A4, pri katerih zmanjšana učinkovitost (npr. peroralnega kontraceptiva) ni zaželjena.
Following the repeat dose administration at the recommended dose, siltuximab clearance was found to be time-invariant, and systemic accumulation was moderate (accumulation index of 1.7).
Po večkratnem odmerjanju priporočenega odmerka je bil očistek siltuksimaba časovno nespremenljiv, sistemsko kopičenje pa je bilo zmerno (razmerje kopičenja 1,7).
Your doctor may stop your treatment with SYLVANT straight away.
Zdravnik bo morda takoj prekinil zdravljenje z zdravilom SYLVANT.
Studies in animals with siltuximab have shown no adverse effect on pregnancy or on embryofetal development (see section 5.3).
Študije siltuksimaba na živalih ne kažejo neželenih učinkov na nosečnost ali na embriofetalni razvoj (glejte poglavje 5.3).
Siltuximab clearance increased with increasing body weight; however, no dose adjustment is required for body weight since administration is on an mg/kg basis.
Očistek siltuksimaba se je povečeval z večjo telesno maso, vendar prilagajanje odmerjanja ni potrebno, saj se zdravilo odmerja glede na telesno maso (mg/kg).
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA
Siltuximab treatment in MCD results in rapid and sustained decreases in CRP serum concentrations.
Zdravljenje Castlemanove bolezni s siltuksimabom povzroči hitro in trajno zmanjšanje koncentracije CRP v serumu.
It is not known if SYLVANT may affect the baby or a pregnant or breast-feeding woman.
Ni znano, ali zdravilo SYLVANT lahko škoduje otroku, nosečnici oziroma doječi materi.
Discontinuing the medicinal product should be considered if there are more than 2 dose delays due to toxicities related to the treatment during the first 48 weeks.
Če v prvih 48 tednih zdravljenja več kot dvakrat odložite odmerjanje zaradi toksičnosti povezanih z zdravljenjem, je treba razmisliti o prenehanju zdravljenja s tem zdravilom.
In non-clinical studies, interleukin-6 (IL-6) is known to decrease the activity of cytochrome P450 (CYP450).
Iz predkliničnih študij je znano, da interlevkin-6 (IL-6) zmanjšuje aktivnost encimov citokroma P450
Following the first administration of siltuximab (doses ranging from 0.9 to 15 mg/kg), the area under the concentration-time curve (AUC) and maximal serum concentration (Cmax) increased in a dose-proportional manner and clearance (CL) was independent of dose.
Po prvem odmerjanju siltuksimaba (z odmerki od 0,9 do 15 mg/kg) sta se krivulja časovnega poteka koncentracije (AUC) in najvišja koncentracija v serumu (Cmax) povečevali v odvisnosti od velikosti odmerka, očistek pa je bil neodvisen od velikosti odmerka.
Infections, including localised infections, should be treated prior to administration of SYLVANT.
Okužbe, vključno z lokaliziranimi, je treba pozdraviti pred odmerjanjem zdravila SYLVANT.
It is well established that IL-6 stimulates the acute-phase expression of C-reactive protein (CRP).
Znano je, da IL-6 stimulira ekspresijo C-reaktivnega proteina, ki je protein akutne faze.
Haematology laboratory tests should be performed prior to each dose of SYLVANT therapy for the first 12 months and every third dosing cycle thereafter.
V prvih 12 mesecih zdravljenja je treba laboratorijske preiskave krvi opraviti pred vsakim odmerjanjem zdravila SYLVANT in nato pred vsakim tretjim krogom odmerjanja.
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.
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%.
• 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).
• 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).
• You must not become pregnant while you are being treated with SYLVANT and for 3 months after your treatment has finished.
• Med zdravljenjem z zdravilom SYLVANT in še 3 mesece po zaključku zdravljenja ne smete zanositi.
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.
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.
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.
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).
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.
Če se pri bolniku zaradi infuzije razvije huda infuzijska reakcija, anafilaksija, huda alergijska reakcija ali sindrom sproščanja citokinov, je treba infundiranje zdravila SYLVANT prekiniti.
As with other immunoglobulin G antibodies, siltuximab crosses the placenta as observed in studies in monkeys.
Tako kot drugi imunoglobulini G (protitelesa IgG) tudi siltuksimab prehaja preko placente, kar so opazili v raziskavah na opicah.
• warfarin, a blood thinner
• varfarin, zdravilo za redčenje krvi
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.
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.
The overall tumour response rate was evaluated based on modified Cheson criteria both by independent review and investigator assessment.
Delež bolnikov s celokupnim tumorskim odzivom so tako neodvisni ocenjevalci kot raziskovalci v študiji ocenjevali po modificiranih Chesonovih kriterijih.
No case of overdose has been reported in clinical trials.
V kliničnih študijah niso poročali o primerih prevelikega odmerjanja.
Upon resolution of the reaction, reinitiating the infusion at a lower infusion rate and therapeutic administration of antihistamines, acetaminophen, and corticosteroids may be considered.
Ko reakcija izzveni, lahko razmislite o ponovni uvedbi infuzije z manjšo hitrostjo in dodajanju antihistaminikov, paracetamola in kortikosteroidov.
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.
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).
SYLVANT will be given to you by your doctor or nurse, in a hospital or clinic only.
Zdravilo SYLVANT lahko prejmete samo v bolnišnici ali ambulanti, dajala vam ga bosta zdravnik ali medicinska sestra.
• high level of 'uric acid' in the blood, which may cause gout
• visoke koncentracije sečne kisline v krvi, ki lahko povzročijo putiko
• abnormal kidney function test
• nenormalne vrednosti testov za oceno delovanja ledvic
* 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
* 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
Haemoglobin response was defined as a change from baseline of ≥ 15 g/L (0.9 mmol/L) at Week 13.
Hemoglobinski odziv je bil opredeljen kot sprememba od izhodiščne vrednosti za ≥ 15 g/l (0,9 mmol/l) po 13 tednih zdravljenja.
a SYLVANT may increase haemoglobin levels in MCD patients
a zdravilo SYLVANT lahko poveča koncentracijo hemoglobina pri bolnikih z MCD
• SYLVANT is supplied as a glass vial containing a white powder for concentrate for solution for infusion (powder for concentrate).
• Zdravilo SYLVANT je na voljo v stekleni viali, ki vsebuje bel prašek za pripravo koncentrata za raztopino za infundiranje (prašek za koncentrat).
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).
Siltuksimab je monoklonsko protitelo (posebna beljakovina), ki se v telesu selektivno veže na antigen (tarčna beljakovina) imenovan interlevkin-6 (IL-6).
• you have liver disease or changes that show up in blood tests of the liver.
• če imate bolezen jeter ali spremembe v krvnih testih jetrne fukcije.
The following side effects may happen with this medicine.
Pri uporabi tega zdravila lahko se lahko pojavijo naslednji neželeni učinki.
Do not use if you see opaque or foreign particles and/or if the solution appears discoloured after reconstitution.
Ne uporabljajte, če je raztopina motna ali v njej plavajo tuji delci in/ali če se je po rekonstituciji raztopina obarvala.
Best tumour response (investigator assessment)
najboljši tumorski odziv (po oceni raziskovalcev)
Hypoglobulinaemia was observed in 4 to 11.3% of patients in the clinical study.
Pri 4-11,3% bolnikov v klinični študiji so opazili hemoglobinemijo.
• SYLVANT is not recommended for use during pregnancy.
• Uporaba zdravila SYLVANT v nosečnosti ni priporočljiva.
Decreases in total IgG, IgA, or IgM levels below normal were observed in the range of 4 to 11%
V študiji MCD (študija 1) so opazili zmanjšanja v celokupnih vrednostih IgG, IgA ali IgM v razponu od 4 do 11%.
Multicentric Castleman's disease causes benign tumours (non-cancerous growths) to develop in the lymph nodes in the body.
Multicentrična Castlemanova bolezen povzroči, da se v bezgavkah po telesu razvijejo benigni tumorji (nerakaste tvorbe).
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).
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).
Select efficacy results from Study 1 in the hyaline vascular subgroup are summarised in Table 4.
Izbrani rezultati o učinkovitosti v podskupini s hialino vaskularnim histološkim podtipom iz študije 1 so povzeti v preglednici 4.
Siltuximab must be administered as an intravenous infusion.
Siltuksimab se daje z intravensko infuzijo.
Intravenous infusion after reconstitution and dilution.
Za intravensko infundiranje po rekonstituciji in redčenju.
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.
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.
Siltuximab is a human-mouse chimeric monoclonal antibody that forms high affinity, stable complexes with soluble bioactive forms of human IL-6.
Siltuksimab je človeško-glodalsko himerno monoklonsko protitelo, ki z visoko afiniteto tvori stabilne komplekse s topno, biološko aktivno obliko človeškega IL-6.
Histological subtype was similar in both treatment arms, with 33% hyaline vascular subtype, 23% plasmacytic subtype and 44% mixed subtype.
hialino vaskularnega podtipa, 23% plazmacitnega podtipa in 44% mešanega podtipa.