FrancophonIA/ELRC3.0 huggingface dataset:
English: Study 2 In addition to Study 1, efficacy data are available in patients with CD from a single arm Phase 1 study
Slovenian: 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).
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: • high fat levels in your blood (hypertriglyceridaemia)
Slovenian: • zvečana koncentracija maščob v krvi (hipertrigliceridemija)
English: 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)]
Slovenian: 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)]
English: 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.
Slovenian: 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.
English: 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.
Slovenian: starejših od 65 let v primerjavi z bolniki starimi 65 let ali manj.
English: Protocol:
Slovenian: Načrt registra:
English: Table 2 lists adverse reactions observed in MCD patients treated with siltuximab at the recommended dosage of 11 mg/kg every 3 weeks.
Slovenian: 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.
English: • Gently swirl (DO NOT SHAKE OR VORTEX OR SWIRL VIGOROUSLY) the reconstituted vials to aid the dissolution of the powder.
Slovenian: • Vialo z rekonstituirano raztopino nežno zavrtite (PRI TEM VIALE NE SMETE STRESATI, SUKATI ALI UPORABLJATI VORTEX MEŠALNIKOV), da se bo prašek lažje raztopil.
English: • swelling in the arms, legs, neck or face
Slovenian: • otekanje rok, nog, vratu ali obraza
English: Interleukin-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T-cells and B-cells,
Slovenian: 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.
English: By binding to IL-6, siltuximab blocks its activity and stops abnormal cell growth.
Slovenian: Siltuksimab se veže na IL-6, onemogoči njegovo delovanje in ustavi nenormalno rast celic.
English: Powder for concentrate for solution for infusion (powder for concentrate).
Slovenian: FARMACEVTSKA OBLIKA prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat)
English: In cultures of human hepatoma cells, IL-6-stimulated production of the acute-phase protein serum amyloid A was dose-dependently inhibited by siltuximab.
Slovenian: V kulturah celic človeškega hepatoma je siltuksimab v odvisnosti od odmerka zaviral z IL-6-stimulirano nastajanje serumskega amiloida A (protein akutne faze).
English: 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).
Slovenian: 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).
English: Siltuximab has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s troji Siltuksimab nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Appropriate personnel and medicinal product should be available to treat anaphylaxis if it occurs (see section 4.8).
Slovenian: Usposobljeno osebje in zdravila za obvladovanje anafilaksije morajo biti vedno na voljo (glejte poglavje 4.8).
English: • The other ingredients (excipients) are histidine, histidine hydrochloride monohydrate, polysorbate 80, and sucrose.
Slovenian: • Druge sestavine (pomožne snovi) zdravila so histidin, histidinijev klorid monohidrat, polisorbat 80 in saharoza.
English: • 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.
Slovenian: • 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.
English: The recommended dose is 11 mg/kg siltuximab given over 1 hour as an intravenous infusion administered every 3 weeks until treatment failure.
Slovenian: Priporočeni odmerek je 11 mg siltuksimaba/kg z intravensko infuzijo, ki traja 1 uro.
English: Slowly add the total volume of reconstituted SYLVANT solution to the 250 mL infusion bag.
Slovenian: Celotni volumen raztopine zdravila SYLVANT počasi dodajate v 250 ml infuzijsko vrečko.
English: You and your doctor should decide if you will continue to take SYLVANT, or breast-feed and discontinue SYLVANT.
Slovenian: Skupaj z zdravnikom se morata odločiti, ali boste nadaljevali s prejemanjem zdravila SYLVANT ali dojili.
English: SYLVANT should remain at room temperature for the duration of the preparation.
Slovenian: Med pripravljanjem naj ima zdravilo SYLVANT sobno temperaturo.
English: Excipients: histidine, histidine hydrochloride monohydrate, polysorbate 80, sucrose.
Slovenian: Pomožne snovi: histidin, histidinijev klorid monohidrat, polisorbat 80, saharoza
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: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji in redčenju zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
English: Nausea, abdominal pain, vomiting, constipation, diarrhoea, gastroesophageal reflux disease, mouth ulceration
Slovenian: Bolezni prebavil zelo pogosti navzea, bolečine v trebuhu, bruhanje, zaprtje, driska, gastroezofagealna refluksna bolezen, razjede v ustih
English: You may be more likely to get infections while you are being treated with SYLVANT.
Slovenian: Med zdravljenjem z zdravilom SYLVANT ste lahko bolj nagnjeni k okužbam.
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: 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.
Slovenian: Izvesti register z namenom zbiranja podatkov o bolnikih s Castelmanovo boleznijo, primernih za zdravljenje z zdravilom z zdravilom Sylvant ali se zdravijo z zdravilom
English: Signs include: difficulty breathing, chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash.
Slovenian: Znaki so zasoplost (težko dihanje), tiščanje v prsih, piskanje v pljučih, huda vrtoglavica ali omotica, otekle ustnice ali kožni izpuščaj.
English: 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.
Slovenian: 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.
English: Durable tumour & symptomatic response (investigator review) Best tumour response (independent review)
Slovenian: Sekundarni cilji za oceno učinkovitosti trajni tumorski in simptomatskega odziv (po oceni raziskovalcev) najboljši tumorski odziv (po oceni neodvisnih ocenjevalcev)
English: Signs include: cough, flu-like symptoms, feeling unwell, red or hot skin, fever.
Slovenian: Ti znaki so lahko: kašelj, gripi podobni simptomi, slabo počutje, pordela ali vroča koža,
English: Gently swirl (DO NOT SHAKE OR VORTEX OR SWIRL VIGOROUSLY) the reconstituted vials to aid the dissolution of the powder.
Slovenian: Vialo z rekonstituirano raztopino nežno zavrtite (PRI TEM VIALE NE SMETE STRESATI, SUKATI ALI UPORABLJATI VORTEX MEŠALNIKOV), da se bo prašek lažje raztopil.
English: Tell your doctor straight away if you have a severe allergic reaction during or after the infusion.
Slovenian: Če se med ali po infundiranju pojavi huda alergijska reakcija, to takoj povejte zdravniku.
English: SYLVANT-treated patients with known hepatic impairment as well as patients with elevated transaminase or bilirubin levels should be monitored.
Slovenian: Bolnike z okvaro jeter in bolnike z zvečanimi koncentracijami transaminaz ali bilirubina, ki prejemajo zdravilo Sylvant je treba spremljati.
English: After reconstitution the solution contains 20 mg siltuximab per mL.
Slovenian: Po rekonstituciji zdravilo vsebuje 20 mg siltuksimaba na mililiter.
English: 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.
Slovenian: 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.
English: (Study 2).
Slovenian: Študija 2
English: 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.
Slovenian: 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.
English: Rodent carcinogenicity studies have not been conducted with siltuximab.
Slovenian: Pri glodalcih niso izvajali študij kancerogenosti siltuksimaba.
English: 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.
Slovenian: Prekomerna tvorba IL-6 pri kroničnih vnetnih in malignih boleznih je povezana z anemijo in kaheksijo.
English: Tell your doctor straight away if you get any signs of infection during treatment with SYLVANT.
Slovenian: Če v času zdravljenje z zdravilom SYLVANT opazite kakršnekoli znake okužbe, takoj obvestite zdravnika.
English: • drop in the number of platelets (thrombocytopenia)
Slovenian: • zmanjšanje števila trombocitov (trombocitopenija)
English: No formal study of the effect of hepatic impairment on the pharmacokinetics of siltuximab has been conducted.
Slovenian: Formalnih študij vpliva jetrne okvare na farmakokinetiko siltuksimaba niso izvedli.
English: Effects of siltuximab on fertility have not been evaluated in humans.
Slovenian: Plodnost Pri ljudeh vpliva siltuksimaba na plodnost niso preučevali.
English: The product is a freeze-dried white powder.
Slovenian: Zdravilo vsebuje bel liofiliziran prašek.
English: SYLVANT passes into breast milk.
Slovenian: • Ni znano ali zdravilo SYLVANT prehaja v materino mleko.
English: Table 1: Treatment criteria Laboratory parameter
Slovenian: Preglednica 1: Kriteriji za zdravljenje laboratorijski parameter zahtevana vrednost pred prvim odmerjanjem zdravila SYLVANT
English: Renal and/or hepatic impairment
Slovenian: Zmanjšano delovanje ledvic in/ali jeter
English: Gastrointestinal (GI) perforation has been reported in siltuximab clinical trials although not in MCD trials.
Slovenian: V kliničnih študijah (vendar ne v študijah MCD) siltuksimaba so poročali o perforacijah gastrointestinalnega trakta.
English: Janssen Biologics B.V. Einsteinweg 101
Slovenian: Janssen Biologics B.V.
English: Each 400 mg vial should be reconstituted with 20 mL of single-use water for injections to yield a 20 mg/mL solution.
Slovenian: Eno400 ml vialo je treba rekonstituirati z 20 ml vode za injekcije za enkratno uporabo, da nastane raztopina z 20 mg/ml.
English: Haemoglobin increase > 15 g/L (0.9 mmol/L) at Week 13/haemoglobin response-evaluable population Durable complete symptomatic responsed
Slovenian: (0,17; 1,13)c zvečanje koncentracije hemoglobina na > 15 g/l (0,9 mmol/l) po 13 tednih pri populaciji s podatkom o koncentraciji hemoglobina trajni popolni simptomatski odzivd
English: What you need to know before you are given SYLVANT You should not be given SYLVANT if:
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo SYLVANT Kako boste prejemali zdravilo SYLVANT
English: The percent change from baseline in MCD-related signs and symptoms and MCD-related overall symptom score at each cycle was calculated.
Slovenian: Izračunali so tudi odstotno spremembo ocene omenjenih znakov in simptomov od izhodiščne vrednosti in skupno oceno omenjenih simptomov pri vsakem krogu zdravljenja.
English: No major age-related differences in pharmacokinetics (PK) or in safety profile were observed in clinical studies.
Slovenian: V kliničnih študijah razlik v farmakokinetičnih in varnostnih lastnosti zdravila glede na starost bolnikov niso opazili.
English: HR 0.418
Slovenian: 134 dni razmerje ogroženosti (HR) 0,418
English: Infusion bags (250 mL) must contain Dextrose 5% and must be made of polyvinyl chloride (PVC), or polyolefin (PO), or polypropylene (PP), or polyethylene (PE).
Slovenian: Za pripravo priporočamo iglo 21G dolžine 38 mm. Infuzijska vrečka (250 ml) mora vsebovati 5% raztopino glukoze, narejena pa mora biti iz polivinil klorida (PVC), poliolefina (PO), polipropilena (PP) ali polietilena (PE).
English: • stomach pain or discomfort, constipation, diarrhoea, heartburn, ulcers (sores) in the mouth,
Slovenian: • bolečine ali nelagodje v trebuhu, zaprtje, driska, zgaga, razjede v ustih, siljenje na bruhanje,
English: Use with caution in patients who may be at increased risk for GI perforation.
Slovenian: Pri bolnikih s povečanim tveganjem za perforacijo gastrointestinalnega trakta zdravilo uporabljajte previdno.
English: The population PK of siltuximab were analysed to evaluate the effects of demographic characteristics.
Slovenian: Za oceno vpliva demografskih lastnosti bolnikov so analizirali populacijsko farmakokinetiko siltuksimaba.
English: Therefore, prescribers should diligently monitor patients receiving treatment in order to detect serious infections.
Slovenian: Da bi lahko odkrili pojav resne okužbe, je treba zelo pozorno spremljati bolnike, ki prejemajo zdravilo.
English: Each 100 mg vial should be reconstituted with 5.2 mL of single-use water for injections to yield a 20 mg/mL solution.
Slovenian: Eno100 ml vialo je treba rekonstituirati s 5,2 ml vode za injekcije za enkratno uporabo, da nastane raztopina z 20 mg/ml.
English: Serious infections, including pneumonia and sepsis, were observed during clinical studies (see section 4.8).
Slovenian: kliničnih študijah so opažali pojav resnih okužb, med drugim pljučnice in sepse (glejte poglavje 4.8).
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Zdravilo je samo za enkratno uporabo.
English: For patients with baseline calculated creatinine clearance of 12 mL/min or greater, there was no meaningful effect on siltuximab PK. Four patients with severe renal impairment (creatinine clearance 12 to 30 mL/min) were included in the data set.
Slovenian: Podatki vključujejo tudi podatke štirih bolnikov s hudo ledvično okvaro (očistek kreatinina 12 do 30ml/min).
English: Siltuximab crossed the placenta during gestation whereby fetal serum concentrations of siltuximab at gestation day (GD) 140 were similar to maternal concentrations.
Slovenian: Siltuksimab je prehajal preko placente tako, da je bila (na 140. dan brejosti) koncentracija siltuksimaba pri plodu podobna kot pri samici.
English: You are severely allergic to siltuximab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo SYLVANT Zdravila SYLVANT ne smete prejemati, če: imate hudo alergijo na siltuksimab ali katero koli drugo sestavino tega zdravila (navedeno v poglavju 6).
English: A total of 79 patients with symptomatic MCD were randomised and treated.
Slovenian: Skupno so randomizirali in zdravili 79 bolnikov s simptomatsko multicentrično Castlemanovo boleznijo.
English: Blood and lymphatic system disorders very common
Slovenian: Bolezni krvi in limfatičnega sistema zelo pogosti nevtropenija, trombocitopenija
English: Package leaflet: Information for the patient SYLVANT 100 mg powder for concentrate for solution for infusion siltuximab This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo SYLVANT 100 mg prašek za koncentrat za raztopino za infundiranje siltuksimab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Binding bioactive IL-6 by siltuximab may result in increased metabolism of CYP450 substrates, because CYP450 enzyme activity will normalise.
Slovenian: CYP450 normalizira, s tem pa se presnova substratov CYP450 poveča.
English: MCD-related signs and symptoms were prospectively collected.
Slovenian: Podatke o znakih in simptomih multicentrične Castlemanove bolezni so zbirali prospektivno.
English: Characteristics, section 4.2).
Slovenian: (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: • you have high level of fats in your blood (hypertriglyceridaemia) - this is because SYLVANT may increase these levels.
Slovenian: • če imate zvečano koncentracijo maščob v krvi (hipertrigliceridemijo) - zdravilo SYLVANT
English: • The active substance is siltuximab.
Slovenian: • Učinkovina je siltuksimab.
English: Therefore, administering siltuximab with CYP450 substrates that have a narrow therapeutic index has the potential to change therapeutic effects and toxicity of these medicinal products due to alteration in the CYP450 pathways.
Slovenian: Opisani učinek na aktivnost CYP450 pri sočasnem odmerjanju siltuksimaba in substratov CYP450 z majhnim terapevtskim indeksom lahko vpliva na terapevtske učinke in toksično delovanje teh zdravil.
English: What SYLVANT is used for
Slovenian: Za kaj uporabljamo zdravilo SYLVANT
English: Table 2: Adverse reactions in siltuximab treated patients in MCD clinical studies a
Slovenian: Preglednica 2: Neželeni učinki pri bolnikih, ki so prejemali siltuksimab v študijah multicentrične Castlemanove boleznia
English: Elevations in triglycerides and cholesterol (lipid parameters) were observed in patients treated with SYLVANT (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali zdravilo SYLVANT, so opažali zvečanje koncentracij trigliceridov in holesterola (glejte poglavje 4.8).
English: The SYLVANT therapy should be withheld if the patient has a severe infection or any severe non-haematological toxicity and can be restarted at the same dose after recovery.
Slovenian: Zdravljenje z zdravilom SYLVANT je treba odložiti, če ima bolnik hudo okužbo ali kakršnokoli hudo poslabšanje krvne slike zaradi nehematološkega vzroka.
English: Haemoglobina
Slovenian: nazofaringitis
English: Similarly, in cultures of human Burkitt's B-lymphoma cells, the production of immunoglobulin M protein in response to IL-6 was dose-dependently inhibited by siltuximab.
Slovenian: Prav tako je siltuksimab v odvisnosti od odmerka zaviral z IL-6 stimulirano nastajanje proteina imunoglobulina M v kulturah celic B človeškega Burkittovega limfoma.
English: Analyses for both primary and secondary endpoints on various subgroups including age (< 65 years and ≥ 65 years); race (White and Non-White); region (North America, Europe, Middle East and Africa, and Asia Pacific); baseline corticosteroid use (yes and no); prior therapy (yes and no); and MCD histology (plasmatic and mixed histology) consistently showed that the treatment effect favoured the siltuximab arm except for the hyaline vascular subgroup in which no patient achieved the definition of the primary endpoint.
Slovenian: Amerika, regija Evropa, Bližnji Vzhod in Afrika ter Azijsko-pacifiška regija), izhodiščni uporabi kortikosteroidov (da in ne), predhodnem zdravljenju (da in ne) in histologiji multicentrične
English: SYLVANT 100 mg powder for concentrate for solution for infusion 8 mL Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 100 mg of siltuximab.
Slovenian: 8 ml viala iz stekla tipa 1 z elastomernim zamaškom in neprodušno aluminijasto zaporo s snemno zaporko, ki vsebuje 100 mg siltuksimaba.
English: Pharmacodynamic effects In vitro, siltuximab dose-dependently inhibited the growth of an IL-6-dependent murine plasmacytoma cell line in response to human IL-6.
Slovenian: In vitro je siltuksimab (odvisno od odmerka) zaviral z IL-6-stimulirano rast celične linije od IL-6 odvisnega glodalskega plazmacitoma.
English: Do not infuse SYLVANT concomitantly in the same intravenous line with other agents.
Slovenian: Z istim infuzijskim sistemom ne smete sočasno infundirati zdravila SYLVANT in drugih zdravil.
English: Unopened vial
Slovenian: 1 viala
English: During intravenous infusion of SYLVANT, mild to moderate infusion reactions may improve following slowing of or stopping the infusion.
Slovenian: Zmanjšanje hitrosti ali prekinitev intravenskega infundiranja zdravila SYLVANT lahko ublaži blago do zmerno infuzijsko reakcijo.
English: How to store SYLVANT
Slovenian: Kako boste prejemali zdravilo SYLVANT
English: General disorders and administration site conditions very common
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti lokaliziran edem
English: The most serious adverse reaction associated with the use of siltuximab was anaphylactic reaction.
Slovenian: Anafilaktična reakcija je najresnejši neželeni učinek uporabe siltuksimaba.
English: Siltuximab (9.2 and 46 mg/kg/week) did not produce any toxicity of the reproductive tract in cynomolgus monkeys.
Slovenian: Pri opicah cinomolgus siltuksimab (9,2 in 46 mg/kg/teden) ni deloval toksično na spolne organe.
English: Immunogenicity
Slovenian: • omotičnost
English: All clinical studies with SYLVANT excluded patients with clinically significant infections, including those known to be hepatitis B surface antigen positive.
Slovenian: Bolniki z resnimi okužbami (vključno z bolniki, ki so pozitivni na površinski antigen hepatitisa B) niso bili vključeni v klinične študije zdravila SYLVANT.
English: A slight reduction in T-cell dependent antibody response and a reduction in the size of the splenic germinal centers following Keyhole limpet hemocyanin (KLH) immunisation was observed which were considered to be pharmacological responses of IL-6 inhibition and not of toxicological significance.
Slovenian: Megathura crenulata (KLH - Keyhole Limpet Haemocyanin) so opazili rahlo zmanjšanje od celic-T odvisnega protitelesnega odziva in zmanjšanje velikosti germinalnih limfatičnih centrov v vranici.
English: • sore throat
Slovenian: • prehlad • vneto grlo
English: Promptly evaluate patients presenting with symptoms that may be associated with or suggestive of GI perforation.
Slovenian: Bolnike s simptomi, ki so lahko povezani s perforacijo gastrointestinalnega trakta je treba takoj obravnavati.