natgillin/translations-raw huggingface dataset:
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.
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.
There are no data from the use of siltuximab in pregnant women.
O uporabi siltuksimaba pri nosečnicah ni podatkov.
Siltuximab+BSC* Placebo+BSC 95% CIa
Cilji opazovanja za oceno učinkovitosti siltuximab+BSC* placebo+BSC 95% IZa
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.
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.
• During the infusion with SYLVANT, you will be monitored for side effects.
• Med infundiranjem zdravila SYLVANT vas bodo opazovali zaradi morebitnih neželenih učinkov.
* 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
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
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.
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.
Siltuximab is not recommended during pregnancy and in women of childbearing potential not using contraception.
Uporaba siltuksimaba ni priporočljiva pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije in med nosečnostjo.
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.
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.
For patients who do not tolerate the infusion following these interventions, SYLVANT should be discontinued.
Pri bolnikih, ki kljub navedenim ukrepom ne prenašajo infuzije, je treba zdravljenje z zdravilom SYLVANT prekiniti.
The highest total amount of siltuximab administered in any clinical trial so far per dose was 2,190 mg (11 mg/kg).
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.
What SYLVANT is and what it is used for What SYLVANT is
Kaj je zdravilo SYLVANT in za kaj ga uporabljamo Kaj je zdravilo SYLVANT
How SYLVANT works
Kako zdravilo SYLVANT deluje
Siltuximab+BSC* Placebo+BSC P-valuea
placebo+ BSC
• The reconstituted solution should be kept for no more than 2 hours prior to addition into the intravenous bag.
• Rekonstituirana raztopina lahko čaka največ 2 uri, preden jo dodate v infuzijsko vrečko.
• Calculate the dose, total volume of reconstituted SYLVANT solution required and the number of vials needed.
• Izračunajte potrebni odmerek, volumen rekonstituirane raztopine zdravila SYLVANT, in število vial.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before you are given SYLVANT.
Če karkoli od zgoraj navedenega velja za vas (ali o tem niste prepričani), se posvetujte z zdravnikom ali farmacevtom, preden prejmete zdravilo SYLVANT.
It is unknown whether siltuximab is excreted in human milk.
Ni znano, ali se siltuksimab izloča v materino mleko.
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.
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.
30/11/2015 (aligned with expected PSUR cycle)
Prva predložitev podatkov: 30/11/2015 (skladno s časom predložitve PSUR)
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.
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).
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.
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.
Table 4: Select efficacy endpoints for hyaline vascular subgroup from study 1 Efficacy endpoints
Preglednica 4: Izbrani rezultati o učinkovitosti v podskupini s hialino vaskularnim histološkim podtipom iz študije 1
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.
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.
Calculate the dose, total volume of reconstituted SYLVANT solution required and the number of vials needed.
Izračunajte potrebni odmerek, volumen rekonstituirane raztopine zdravila SYLVANT, in število vial.
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).
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%
What SYLVANT looks like and contents of the pack
Izgled zdravila SYLVANT in vsebina pakiranja
Paediatric population The safety and efficacy of siltuximab have not been established in paediatric patients.
Varnost in učinkovitost siltuksimaba pri pediatričnih bolnikih nista bili dokazani.
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.
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).
Before administering the infusion, the prescriber should consider delaying treatment, if the treatment criteria outlined in Table 1 are not met.
Če pred infundiranjem bolnik ne izpolnjuje kriterijev za zdravljenje, navedenih v preglednici 1, je treba razmisliti o odložitvi zdravljenja.
• respiratory infections - such as of the nose, sinuses or throat
• okužbe dihal - nosu, sinusov, žrela ali grla • okužba sečil
• Allow vial(s) of SYLVANT to come to room temperature (15°C to 25°C) over approximately 30 minutes.
• Viale z zdravilom SYLVANT pustite pri sobni temberaturi (15°C-20°C) približno 30 minut, da se segrejejo.
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.
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.
Available non-clinical data do not suggest an effect on fertility under siltuximab treatment (see section 5.3).
Razpoložljivi predklinični podatki ne kažejo, da bi zdravljenje s siltuksimabom vplivalo na plodnost (glejte poglavje 5.3).
Patients with MCD produce too much IL-6 and this is thought to contribute to the abnormal growth of certain cells in lymph nodes.
Pri bolnikih z multicentrično Castelmanovo boleznijo v telesu nastaja preveč IL-6, kar naj bi prispevalo k nenormalni rasti določenih celicah v bezgavkah.
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.
Pri 189 bolnikih so testirali vsaj en vzorec z metodo (high medicinal product-tolerant) ECLIA.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
SYLVANT is a medicine that contains the active substance siltuximab.
Zdravilo SYLVANT vsebuje učinkovino siltuksimab.
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.
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.
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.
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.
Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Huda preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
No formal studies have been conducted to investigate the PK of siltuximab in patients with renal or hepatic impairment (see section 4.4).
Formalnih študij farmakokinetičnih lastnosti siltuksimaba pri bolnikih z okvaro ledvic ali jeter niso izvedli (glejte poglavje 4.4).
The immunogenicity of siltuximab has been evaluated using antigen-bridging enzyme immunoassay (EIA) and electrochemiluminescence (ECL)-based immunoassay (ECLIA)
antigen-bridging EIA - Enzyme immunoassay) in z imunsko metodo ECLIA (Electrochemiluminescence immunoassay), ki temelji na elektrokemiluminiscenci (ECL - Electrochemiluminescence immunoassay).
• No physical biochemical compatibility studies have been conducted to evaluate the co-administration of SYLVANT with other medicinal products.
• Fizikalno-biokemijskih študij kompatibilnosti za oceno odmerjanja zdravila SYLVANT skupaj z drugimi zdravili niso izvedli.
severe dizziness or light-headedness, swelling of the lips or skin rash.
huda vrtoglavica ali omotica, otekanje ustnic ali kožni izpuščaj.
The effect of anti-siltuximab antibody status was not examined, as there were insufficient numbers of anti-siltuximab antibody positive patients.
Vpliva prisotnosti protiteles proti siltuksimabu niso preučevali, saj je bilo število bolnikov s prisotnimi protitelesi proti siltuksimabu premajhno.
Study 2 In addition to Study 1, efficacy data are available in patients with CD from a single arm Phase 1 study
Poleg podatkov iz študije 1 so na voljo tudi podatki o učinkovitosti pri bolnikih s Castlemanovo boleznijo (CD) iz študije faze I z eno samo študijsko skupino (študija 2).
Allow vial(s) of SYLVANT to come to room temperature (15°C to 25°C) over approximately 30 minutes.
Viale z zdravilom SYLVANT pustite pri sobni temberaturi (15°C-20°C) približno 30 minut, da se segrejejo.
• high fat levels in your blood (hypertriglyceridaemia)
• zvečana koncentracija maščob v krvi (hipertrigliceridemija)
Weight increased a All patients with CD treated with siltuximab at recommended dose of 11 mg/kg every 3 weeks [including crossover patients (N = 87)]
Preiskave zelo pogosti povečanje telesne mase a podatki vseh bolnikov s Castlemanovo boleznijo, ki so prejemali siltuksimab v priporočenem odmerku 11 mg/kg vsake 3 tedne [vključno z bolniki, ki so kasneje prešli na uporabo siltuksimaba SYLVANT (n = 87)]
At baseline, 55% of patients in the siltuximab arm and 65% of patients in the placebo arm had received prior systemic therapies for MCD and 30% of patients in the siltuximab arm and 31% in the placebo arm were using corticosteroids.
Ob izhodišču je 55% bolnikov iz skupine s siltuksimabom in 65% bolnikov iz skupine s placebom že prej prejemalo sistemska zdravila za multicentrično Castlemanovo bolezen.
The results showed no significant difference in the PK of siltuximab in patients older than 65 years compared to patients age 65 years or younger.
starejših od 65 let v primerjavi z bolniki starimi 65 let ali manj.
Protocol:
Načrt registra:
Table 2 lists adverse reactions observed in MCD patients treated with siltuximab at the recommended dosage of 11 mg/kg every 3 weeks.
V Preglednici 2 so navedeni neželeni učinki pri bolnikih z multicentrično Castlemanovo boleznijo, ki so prejemali siltuksimab v priporočenem odmerku 11 mg/kg vsake 3 tedne.
• Gently swirl (DO NOT SHAKE OR VORTEX OR SWIRL VIGOROUSLY) the reconstituted vials to aid the dissolution of the powder.
• Vialo z rekonstituirano raztopino nežno zavrtite (PRI TEM VIALE NE SMETE STRESATI, SUKATI ALI UPORABLJATI VORTEX MEŠALNIKOV), da se bo prašek lažje raztopil.
• swelling in the arms, legs, neck or face
• otekanje rok, nog, vratu ali obraza
Interleukin-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T-cells and B-cells,
Interlevkin-6 je pleiotropen provnetni citokin, ki nastaja v različnih vrstah celic, med drugim v celicah T in B, limfocitih, monocitih in fibroblastih, pa tudi v malignih celicah.
By binding to IL-6, siltuximab blocks its activity and stops abnormal cell growth.
Siltuksimab se veže na IL-6, onemogoči njegovo delovanje in ustavi nenormalno rast celic.
Powder for concentrate for solution for infusion (powder for concentrate).
FARMACEVTSKA OBLIKA prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat)
In cultures of human hepatoma cells, IL-6-stimulated production of the acute-phase protein serum amyloid A was dose-dependently inhibited by siltuximab.
V kulturah celic človeškega hepatoma je siltuksimab v odvisnosti od odmerka zaviral z IL-6-stimulirano nastajanje serumskega amiloida A (protein akutne faze).
Median age was 47 years (range 20-74) in the siltuximab arm and 48 years (range 27-78) in the placebo arm. More male patients were enrolled in the placebo arm (85% in placebo vs. 56% in the siltuximab group).
V skupini s siltuksimabom je bila mediana starost bolnikov 47 let (od 20 do 74 let), v skupini s placebom pa 48 let (od 27 do 78 let).
Siltuximab has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja s troji Siltuksimab nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Appropriate personnel and medicinal product should be available to treat anaphylaxis if it occurs (see section 4.8).
Usposobljeno osebje in zdravila za obvladovanje anafilaksije morajo biti vedno na voljo (glejte poglavje 4.8).
• The other ingredients (excipients) are histidine, histidine hydrochloride monohydrate, polysorbate 80, and sucrose.
• Druge sestavine (pomožne snovi) zdravila so histidin, histidinijev klorid monohidrat, polisorbat 80 in saharoza.
• Dilute the total volume of the reconstituted solution dose to 250 mL with sterile dextrose 5%, by withdrawing a volume equal to the volume of reconstituted SYLVANT from the dextrose 5%, 250 mL bag.
• Celotni volumen rekonstituirane raztopine razredčite do volumna 250 ml s sterilno 5-odstotno raztopino glukoze, in sicer tako, da najprej iz 250 ml vrečke s 5% raztopino glukoze potegnete enak volumen, kot ga ima rekonstituirana raztopina zdravila SYLVANT.
The recommended dose is 11 mg/kg siltuximab given over 1 hour as an intravenous infusion administered every 3 weeks until treatment failure.
Priporočeni odmerek je 11 mg siltuksimaba/kg z intravensko infuzijo, ki traja 1 uro.
Slowly add the total volume of reconstituted SYLVANT solution to the 250 mL infusion bag.
Celotni volumen raztopine zdravila SYLVANT počasi dodajate v 250 ml infuzijsko vrečko.
You and your doctor should decide if you will continue to take SYLVANT, or breast-feed and discontinue SYLVANT.
Skupaj z zdravnikom se morata odločiti, ali boste nadaljevali s prejemanjem zdravila SYLVANT ali dojili.
SYLVANT should remain at room temperature for the duration of the preparation.
Med pripravljanjem naj ima zdravilo SYLVANT sobno temperaturo.
Excipients: histidine, histidine hydrochloride monohydrate, polysorbate 80, sucrose.
Pomožne snovi: histidin, histidinijev klorid monohidrat, polisorbat 80, saharoza
The reconstituted solution should be kept for no more than 2 hours prior to addition into the intravenous bag.
Rekonstituirana raztopina lahko čaka največ 2 uri, preden jo dodate v infuzijsko vrečko.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Za pogoje shranjevanja po rekonstituciji in redčenju zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
Nausea, abdominal pain, vomiting, constipation, diarrhoea, gastroesophageal reflux disease, mouth ulceration
Bolezni prebavil zelo pogosti navzea, bolečine v trebuhu, bruhanje, zaprtje, driska, gastroezofagealna refluksna bolezen, razjede v ustih
You may be more likely to get infections while you are being treated with SYLVANT.
Med zdravljenjem z zdravilom SYLVANT ste lahko bolj nagnjeni k okužbam.
No physical biochemical compatibility studies have been conducted to evaluate the co-administration of SYLVANT with other medicinal products.
Fizikalno-biokemijskih študij kompatibilnosti za oceno odmerjanja zdravila SYLVANT skupaj z drugimi zdravili niso izvedli.
A registry should be conducted to collect information on patients with Castleman's disease, who are candidates to receive Sylvant or are currently receiving treatment with Sylvant.
Izvesti register z namenom zbiranja podatkov o bolnikih s Castelmanovo boleznijo, primernih za zdravljenje z zdravilom z zdravilom Sylvant ali se zdravijo z zdravilom
Signs include: difficulty breathing, chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash.
Znaki so zasoplost (težko dihanje), tiščanje v prsih, piskanje v pljučih, huda vrtoglavica ali omotica, otekle ustnice ali kožni izpuščaj.
For patients with baseline alanine transaminase up to 3.7 times the upper limit of normal baseline albumin ranging from 15 to 58 g/L, and baseline bilirubin ranging from 1.7 to 42.8 mg/dL there was no meaningful effect on siltuximab PK.
izhodiščno koncentracijo albuminov od 15 do 58 g/l in izhodiščno koncentracijo bilirubina od 17 do 428 mg/l, okvara jeter ni bistveno vplivala na farmakokinetiko siltuksimaba.
Durable tumour & symptomatic response (investigator review) Best tumour response (independent review)
Sekundarni cilji za oceno učinkovitosti trajni tumorski in simptomatskega odziv (po oceni raziskovalcev) najboljši tumorski odziv (po oceni neodvisnih ocenjevalcev)
Signs include: cough, flu-like symptoms, feeling unwell, red or hot skin, fever.
Ti znaki so lahko: kašelj, gripi podobni simptomi, slabo počutje, pordela ali vroča koža,
Gently swirl (DO NOT SHAKE OR VORTEX OR SWIRL VIGOROUSLY) the reconstituted vials to aid the dissolution of the powder.
Vialo z rekonstituirano raztopino nežno zavrtite (PRI TEM VIALE NE SMETE STRESATI, SUKATI ALI UPORABLJATI VORTEX MEŠALNIKOV), da se bo prašek lažje raztopil.
Tell your doctor straight away if you have a severe allergic reaction during or after the infusion.
Če se med ali po infundiranju pojavi huda alergijska reakcija, to takoj povejte zdravniku.
SYLVANT-treated patients with known hepatic impairment as well as patients with elevated transaminase or bilirubin levels should be monitored.
Bolnike z okvaro jeter in bolnike z zvečanimi koncentracijami transaminaz ali bilirubina, ki prejemajo zdravilo Sylvant je treba spremljati.
After reconstitution the solution contains 20 mg siltuximab per mL.
Po rekonstituciji zdravilo vsebuje 20 mg siltuksimaba na mililiter.
Dilute the total volume of the reconstituted solution dose to 250 mL with sterile Dextrose 5%, by withdrawing a volume equal to the volume of reconstituted SYLVANT from the Dextrose 5%, 250 mL bag.
Celotni volumen rekonstituirane raztopine razredčite do volumna 250 ml s sterilno 5-odstotno raztopino glukoze, in sicer tako, da najprej iz 250 ml vrečke s 5% raztopino glukoze potegnete enak volumen, kot ga ima rekonstituirana raztopina zdravila SYLVANT.
(Study 2).
Študija 2
SYLVANT 400 mg powder for concentrate for solution for infusion 30 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 400 mg of siltuximab.
SYLVANT 400 mg prašek za koncentrat za raztopino za infundiranje 30 ml viala iz stekla tipa 1 z elastomernim zamaškom in neprodušno aluminijasto zaporo s snemno zaporko, ki vsebuje 400 mg siltuksimaba.
Rodent carcinogenicity studies have not been conducted with siltuximab.
Pri glodalcih niso izvajali študij kancerogenosti siltuksimaba.
Overproduction of IL-6, in chronic inflammatory diseases and malignancies has been linked to anaemia and cachexia and has been hypothesised to play a central role in driving plasma cell proliferation and systemic manifestations in patients with CD.
Prekomerna tvorba IL-6 pri kroničnih vnetnih in malignih boleznih je povezana z anemijo in kaheksijo.
Tell your doctor straight away if you get any signs of infection during treatment with SYLVANT.
Če v času zdravljenje z zdravilom SYLVANT opazite kakršnekoli znake okužbe, takoj obvestite zdravnika.
• drop in the number of platelets (thrombocytopenia)
• zmanjšanje števila trombocitov (trombocitopenija)
No formal study of the effect of hepatic impairment on the pharmacokinetics of siltuximab has been conducted.
Formalnih študij vpliva jetrne okvare na farmakokinetiko siltuksimaba niso izvedli.
Effects of siltuximab on fertility have not been evaluated in humans.
Plodnost Pri ljudeh vpliva siltuksimaba na plodnost niso preučevali.
The product is a freeze-dried white powder.
Zdravilo vsebuje bel liofiliziran prašek.
SYLVANT passes into breast milk.
• Ni znano ali zdravilo SYLVANT prehaja v materino mleko.
Table 1: Treatment criteria Laboratory parameter
Preglednica 1: Kriteriji za zdravljenje laboratorijski parameter zahtevana vrednost pred prvim odmerjanjem zdravila SYLVANT