FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Nakon liječenja lijekom SYLVANT, u kliničkim ispitivanjima prijavljeni su prolazni ili povremeni blagi do umjereni porast razina jetrenih transaminaza ili drugih testova jetrene funkcije, poput bilirubina.
English: SYLVANT 400 mg powder for concentrate for solution for infusion EU/1/14/928/002
Croatian: SYLVANT 400 mg prašak za koncentrat za otopinu za infuziju EU/1/14/928/002
English: Table 2: Adverse reactions in siltuximab treated patients in MCD clinical studies a
Croatian: Tablica 2: Nuspojave u bolesnika liječenih siltuksimabom u kliničkim ispitivanjima MCD
English: After reconstitution the solution contains 20 mg siltuximab per mL.
Croatian: Nakon rekonstitucije otopina sadrži 20 mg siltuksimaba po ml.
English: The immunogenicity of siltuximab has been evaluated using antigen-bridging enzyme immunoassay (EIA) and electrochemiluminescence (ECL)-based immunoassay (ECLIA)
Croatian: Imunogenost siltuksimaba bila je procijenjena koristeći enzimsko-imunološku pretragu (EIA) premoštavanjem antigenom i elektrokemiluminescentnom (ECL) imunometodom (ECLIA).
English: Allow vial(s) of SYLVANT to come to room temperature (15°C to 25°C) over approximately 30 minutes.
Croatian: Pustite da bočica/e s lijekom SYLVANT dosegne sobnu temperaturu (15°C do 25°C) tijekom otprilike 30 minuta.
English: Decreases in total IgG, IgA, or IgM levels below normal were observed in the range of 4 to 11%
Croatian: Smanjenja razina ukupnih IgG, IgA ili IgM ispod normalnih, opažena su u rasponu od 4 do 11% bolesnika u MCD ispitivanju (Ispitivanje 1).
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na označavanju iza oznake “Rok valjanosti” odnosno “EXP”.
English: • Gently swirl (DO NOT SHAKE OR VORTEX OR SWIRL VIGOROUSLY) the reconstituted vials to aid the dissolution of the powder.
Croatian: • Blago zavrtite (NEMOJTE TRESTI ILI RADITI VRTLOG ILI SNAŽNO VRTITI) rekonstituirane bočice kako biste potpomogli otapanje praška.
English: What SYLVANT is and what it is used for What you need to know before you are given SYLVANT How SYLVANT is given
Croatian: Što je SYLVANT i za što se koristi Što morate znati prije nego počnete primati SYLVANT Kako primjenjivati SYLVANT Moguće nuspojave
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.
Croatian: Potpuni simptomatski odgovor bio je definiran kao 100%-tno smanjenje od početne vrijednosti rezultata za ukupne simptome povezane s MCD-om, koji je trajao barem 18 tjedana prije zatajenja liječenja.
English: Siltuximab has no or negligible influence on the ability to drive and use machines.
Croatian: Siltuksimab malo ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: How SYLVANT works
Croatian: Kako SYLVANT djeluje
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.
Croatian: Siltuksimab sprječava vezanje ljudskog IL-6 i na topive receptore IL-6 (IL-6R) i na IL-6R vezane na membranu, i tako inhibira nastajanje heksamernog signalnog kompleksa s gp130 na površini stanice.
English: • joint pain, arm or leg pain
Croatian: • bol u zglobovima, bol ruku ili nogu
English: • urinary tract infection
Croatian: • infekcija mokraćnih puteva
English: • SYLVANT will be given as an “intravenous infusion” (a drip into a vein, usually in your arm).
Croatian: • SYLVANT će Vam se primijeniti putem “infuzije u venu” (drip u venu, uobičajeno u ruku).
English: • Allow vial(s) of SYLVANT to come to room temperature (15°C to 25°C) over approximately 30 minutes.
Croatian: • Pustite da bočica/e s lijekom SYLVANT dosegne sobnu temperaturu (15°C do 25°C) tijekom otprilike 30 minuta.
English: During or following infusion, treatment should be discontinued in patients who have severe infusion related hypersensitivity reactions (e.g., anaphylaxis).
Croatian: Liječenje se mora prekinuti u bolesnika koji tijekom ili nakon infuzije imaju teške reakcije preosjetljivosti povezane s infuzijom (npr. anafilaksija).
English: It is not known if SYLVANT is safe and effective in this population, therefore SYLVANT should not be given to children and adolescents.
Croatian: Sigurnost i djelotvornost lijeka SYLVANT u ovoj populaciji nisu poznati, stoga se SYLVANT ne smije primjenjivati u djece i adolescenata.
English: Pack size of 1 vial.
Croatian: Pakiranje od 1 bočice.
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.
Croatian: U kulturama ljudskih stanica hepatoma, proizvodnja serumskog amiloida A, proteina akutne faze stimuliranog IL-6 bila je inhibirana siltuksimabom ovisno o dozi.
English: Siltuximab is a human-mouse chimeric monoclonal antibody that forms high affinity, stable complexes with soluble bioactive forms of human IL-6.
Croatian: Siltuksimab je ljudsko-mišje kimerično monoklonsko protutijelo koje s visokim afinitetom formira stabilne komplekse, s topivim, bioaktivnim oblicima ljudskog IL-6.
English: What SYLVANT is used for
Croatian: Za što se SYLVANT koristi
English: • During the infusion with SYLVANT, you will be monitored for side effects.
Croatian: • Tijekom infuzije lijeka SYLVANT, pratit će Vas se zbog nuspojava.
English: It is not known what the possible side effects could be from having too much SYLVANT.
Croatian: Nije poznato koje su moguće nuspojave radi primjene previše lijeka SYLVANT.
English: Do not infuse SYLVANT concomitantly in the same intravenous line with other agents.
Croatian: Nemojte primjenjivati infuziju lijeka SYLVANT istodobno s drugim lijekovima putem iste intravenske linije.
English: Table 4: Select efficacy endpoints for hyaline vascular subgroup from study 1 Efficacy endpoints
Croatian: Tablica 4: Odabrane mjere ishoda za podskupinu hijalinskog vaskularnog podtipa iz ispitivanja 1
English: • The reconstituted solution should be kept for no more than 2 hours prior to addition into the intravenous bag.
Croatian: • Rekonstituirana otopina ne smije se čuvati dulje od 2 sata prije dodavanja u infuzijsku vrećicu.
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
Croatian: U vrijeme primarne analize podaci za 19 od 20 ispitanika s tumorskim i simptomatskim odgovorom bili su cenzurirani zbog odgovora koji je bio u tijeku c N/P = “Nije primjenjivo”, nije bilo ispitanika s odgovorom u placebo skupini, stoga trajanje nije primjenjivo d Potpuni simptomatski odgovor je definiran kao 100%-tno smanjenje od početne vrijednosti rezultata za ukupne simptome povezane s MCD-om koji je trajao barem 18 tjedana prije zatajenja liječenja e Podaci za 11 od 13 ispitanika koji su imali potpuni simptomatski odgovor bili su cenzurirani zbog odgovora koji je bio u tijeku
English: Duration of tumour & symptomatic response (days) - independent review; median (min, max)
Croatian: Trajanje tumora i simptomatski odgovor (dani)nezavisna procjena; medijan (minimum, maksimum)
English: Gently swirl (DO NOT SHAKE OR VORTEX OR SWIRL VIGOROUSLY) the reconstituted vials to aid the dissolution of the powder.
Croatian: Blago zavrtite (NEMOJTE TRESTI ILI RADITI VRTLOG ILI SNAŽNO VRTITI) rekonstituirane bočice kako biste potpomogli otapanje praška.
English: Durable complete symptomatic responsed Duration of durable complete symptomatic response (days) median (min, max)
Croatian: Trajni potpuni simptomatski odgovord Trajanje trajnog simptomatskog odgovora (dani) medijan (minimum, maksimum)
English: No formal studies have been conducted to investigate the PK of siltuximab in patients with renal or hepatic impairment (see section 4.4).
Croatian: Nisu provedena formalna ispitivanja u kojima se istraživala farmakokinetika siltuksimaba u bolesnika s oštećenjem bubrega ili jetre (vidjeti dio 4.4).
English: • Calculate the dose, total volume of reconstituted SYLVANT solution required and the number of vials needed.
Croatian: • Izračunajte dozu, ukupni volumen potrebne rekonstituirane otopine lijeka SYLVANT i broj potrebnih bočica.
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)]
Croatian: Pretrage vrlo često povećana težina a Svi bolesnici s CD liječeni siltuksimabom pri preporučenoj dozi od 11 mg/kg svaka 3 tjedna [uključujući bolesnike koji su prešli u tu skupinu (N = 87)]
English: Talk to your doctor, pharmacist or nurse if you notice any of the following side effects:
Croatian: Odmah obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako primijetite bilo koju od sljedećih nuspojava:
English: • 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.
Croatian: • U nekim slučajevima, ako ste trudni i potrebno Vam je liječenje MCD-a, Vaš liječnik može savjetovati da korist uzimanja lijeka SYLVANT za Vaše zdravlje prevladava u odnosu na moguće rizike za
English: Signs include: difficulty breathing, chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash.
Croatian: Znakovi uključuju: poteškoće s disanjem, stezanje u prsima, piskanje pri disanju, tešku omaglicu ili ošamućenost, oticanje usnica ili kožni osip.
English: What SYLVANT is and what it is used for What SYLVANT is
Croatian: Što je SYLVANT i za što se koristi
English: • No physical biochemical compatibility studies have been conducted to evaluate the co-administration of SYLVANT with other medicinal products.
Croatian: • Nisu provedena fizikalna biokemijska ispitivanja kompatibilnosti kojima bi se procijenila istovremena primjena lijeka SYLVANT s drugim lijekovima.
English: Table 2 reflects the frequencies of identified adverse reactions in the 87 MCD patients (Study 1, Study 2 and Study 3) treated at the recommended dosage of 11 mg/kg every 3 weeks (details provided in section 5.1).
Croatian: Tablica 2 prikazuje učestalosti identificiranih nuspojava na siltuksimab u 87 bolesnika s MCD (Ispitivanje 1, Ispitivanje 2 i Ispitivanje 3) pri preporučenom doziranju od 11 mg/kg svaka 3 tjedna (pojedinosti dostupne u dijelu 5.1).
English: Calculate the dose, total volume of reconstituted SYLVANT solution required and the number of vials needed.
Croatian: Izračunajte dozu, ukupni volumen potrebne rekonstituirane otopine lijeka SYLVANT i broj potrebnih bočica.
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
Croatian: N/P = “Nije primjenjivo”, nije bilo ispitanika s odgovorom stoga 95%-tni CI nije primjenjiv c 95%-tni interval pouzdanosti za omjer hazarda d Potpuni simptomatski odgovor je definiran kao 100%-tno smanjenje od početne vrijednosti rezultata za ukupne simptome povezane s MCD-om koji je trajao barem 18 tjedana prije zatajenja liječenja
English: Table 2 lists adverse reactions observed in MCD patients treated with siltuximab at the recommended dosage of 11 mg/kg every 3 weeks.
Croatian: U Tablici 2 navedene su nuspojave uočene u bolesnika s MCD koji su liječeni siltuksimabom pri preporučenom doziranju od 11 mg/kg svaka 3 tjedna.
English: The percent change from baseline in MCD-related signs and symptoms and MCD-related overall symptom score at each cycle was calculated.
Croatian: U svakom ciklusu izračunat je postotak promjene od početne vrijednosti kod znakova i simptoma povezanih s MCD-om i rezultat za ukupne simptome povezane s MCD-om.
English: • Any unused product or waste material should be disposed of in accordance with local requirements.
Croatian: • Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Siltuximab+BSC* Placebo+BSC P-valuea
Croatian: Placebo+BSC P-vrijednost a
English: The reconstituted solution should be kept for no more than 2 hours prior to addition into the intravenous bag.
Croatian: Rekonstituirana otopina ne smije se čuvati dulje od 2 sata prije dodavanja u infuzijsku vrećicu.
English: • The other ingredients (excipients) are histidine, histidine hydrochloride monohydrate, polysorbate 80, and sucrose.
Croatian: • Drugi sastojci (pomoćne tvari) su histidin, histidinklorid hidrat, polisorbat 80 i saharoza.
English: SYLVANT-treated patients with known hepatic impairment as well as patients with elevated transaminase or bilirubin levels should be monitored.
Croatian: Potrebno je pratiti bolesnike s poznatim oštećenjem jetre koji se liječe lijekom SYLVANT, isto kao i bolesnike s povišenim razinama transaminaza ili bilirubina.
English: As this medicine will be given to you by your doctor or nurse, it is unlikely that you will be given too much.
Croatian: Ako Vam se primijeni više lijeka SYLVANT nego što se trebalo Budući da će Vam ovaj lijek primijeniti liječnik ili medicinska sestra, nije vjerojatno da će Vam biti primijenjeno previše lijeka.
English: How to store SYLVANT
Croatian: Kako čuvati SYLVANT
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).
Croatian: Medijan dobi bio je 47 godina (raspon 20-74) u skupini liječenoj siltuksimabom i 48 godina (raspon 27-78) u skupini liječenoj placebom.
English: Nausea, abdominal pain, vomiting, constipation, diarrhoea, gastroesophageal reflux disease, mouth ulceration
Croatian: Poremećaji probavnog sustava vrlo često mučnina, abdominalna bol, povraćanje, konstipacija, proljev, gastroezofagealna refluksna bolest, ulceracije u ustima
English: Best tumour response (independent review) Best tumour response (investigator assessment) 27/53 (50.9%)
Croatian: Najbolji tumorski odgovor (nezavisna procjena) 20/53 (37,7%) 1/26 (3,8%) Najbolji tumorski odgovor (procjena ispitivača)
English: Retreatment criteria
Croatian: Kriteriji za ponovljeno liječenje
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rekonstituciji i razrjeđivanju lijeka prije primjene vidjeti dio 6.6. 4.3 Kontraindikacije
English: No physical biochemical compatibility studies have been conducted to evaluate the co-administration of SYLVANT with other medicinal products.
Croatian: Nisu provedena fizikalna biokemijska ispitivanja kompatibilnosti kojima bi se procijenila istovremena primjena lijeka SYLVANT s drugim lijekovima.
English: Effects of siltuximab on fertility have not been evaluated in humans.
Croatian: Nisu procijenjeni učinci siltuksimaba na plodnost u ljudi.
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.
Croatian: In vitro, siltuksimab je ovisno o dozi inhibirao rast murinske plazmocitomske stanične linije ovisne o IL-6, kao odgovor na ljudski IL-6.
English: The following side effects may happen with this medicine.
Croatian: Uz ovaj lijek mogu se javiti sljedeće nuspojave.
English: • swelling in the arms, legs, neck or face
Croatian: • oticanje ruku, nogu, vrata ili lica
English: Talk to your doctor, pharmacist, or nurse before you are given SYLVANT if:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite SYLVANT:
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.
Croatian: • Razrijedite ukupni volumen doze rekonstituirane otopine na 250 ml 5%-tnom sterilnom otopinom glukoze, na način da iz vrećice od 250 ml s 5%-tnom otopinom glukoze povučete volumen jednak volumenu rekonstituiranog lijeka SYLVANT.
English: • drop in the number of platelets (thrombocytopenia)
Croatian: • pad broja trombocita (trombocitopenija)
English: Rodent carcinogenicity studies have not been conducted with siltuximab.
Croatian: Ispitivanja kancerogenosti u glodavaca sa siltuksimabom nisu bila provedena.
English: IV
Croatian: b
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: Do not use if visibly opaque or if foreign particles and/or solution discolouration are present.
Croatian: Nemojte primijeniti ako su prisutne vidljive neprozirne ili strane čestice i/ili je otopina promijenila boju.
English: Haemoglobin increase > 15 g/L (0.9 mmol/L) at Week 13/haemoglobin response-evaluable population
Croatian: Povišenje hemoglobina > 15 g/l (0,9 mmol/l) u 13. tjednu/populacija koja se može procijeniti na odgovor hemoglobina
English: Durable tumour & symptomatic response (investigator review) Best tumour response (independent review)
Croatian: Sekundarne mjere ishoda djelotvornosti Trajni tumorski odgovor i simptomatski odgovor (procjena ispitivača) Najbolji tumorski odgovor (nezavisna procjena)
English: No formal study of the effect of hepatic impairment on the pharmacokinetics of siltuximab has been conducted.
Croatian: Nisu provedena formalna ispitivanja učinka oštećenja bubrega na farmakokinetiku siltuksimaba.
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.
Croatian: U kliničkim ispitivanjima uključujući monoterapiju i ispitivanja kombinacije, za ispitivanje anti-siltuksimab protutijela bili su dostupni uzorci od ukupno 432 bolesnika, s tim da je 189 bolesnika kojima je barem jedan uzorak ispitan ECLIA pretragom koja je visoko tolerantna na lijek.
English: Blood and lymphatic system disorders very common
Croatian: Poremećaji krvi i limfnog sustava vrlo često neutropenija, trombocitopenija
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.
Croatian: Razrijedite ukupni volumen doze rekonstituirane otopine na 250 ml 5%-tnom sterilnom otopinom glukoze, na način da iz vrećice od 250 ml s 5%-tnom otopinom glukoze povučete volumen jednak volumenu rekonstituiranog lijeka SYLVANT.
English: SYLVANT 100 mg powder for concentrate for solution for infusion EU/1/14/928/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET SYLVANT 100 mg prašak za koncentrat za otopinu za infuziju EU/1/14/928/001
English: Haemoglobin increase > 15 g/L (0.9 mmol/L) at Week 13/haemoglobin response-evaluable population Durable complete symptomatic responsed
Croatian: Povišenje hemoglobina > 15 g/L (0,9 mmol/L) u 13. tjednu/populacija koja se može procijeniti na odgovor hemoglobina
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.
Croatian: 3 tjedna) sa srednjom vrijednošću (± SD) vršne i najniže koncentracije lijeka od 332 ± 139 odnosno 84 ± 66 µg/ml.
English: Appropriate personnel and medicinal product should be available to treat anaphylaxis if it occurs (see section 4.8).
Croatian: U slučaju nastupa anafilaksije za liječenje moraju biti dostupni odgovarajuće osoblje i prikladni lijekovi (vidjeti dio 4.8).
English: Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Teška preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1. 4.4 Posebna upozorenja i mjere opreza pri uporabi Sljedivost
English: Interleukin-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T-cells and B-cells,
Croatian: Interleukin-6 je pleiotropni, proupalni citokin kojeg proizvode različite vrste stanica, uključujući T-stanice, B-stanice, limfocite, monocite i fibroblaste, kao i maligne stanice.
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.
Croatian: U skupinu podataka bila su uključena četiri bolesnika s teškim oštećenjem bubrega (klirens kreatinina 12 do 30 ml/min).
English: Use with caution in patients who may be at increased risk for GI perforation.
Croatian: U bolesnika koji mogu imati povišen rizik GI perforacije potrebna je primjena s oprezom.
English: severe dizziness or light-headedness, swelling of the lips or skin rash.
Croatian: piskanje u plućima, tešku omaglicu ili ošamućenost, oticanje usnica ili kožni osip.
English: Histidine hydrochloride monohydrate Polysorbate 80
Croatian: 6.1 Popis pomoćnih tvari histidin histidinklorid hidrat polisorbat 80 saharoza
English: It is unknown whether siltuximab is excreted in human milk.
Croatian: Nije poznato izlučuje li se siltuksimab u majčino mlijeko.
English: Upper respiratory tract infection, urinary tract infection, nasopharyngitis
Croatian: Infekcije i infestacije vrlo često infekcija gornjeg dišnog sustava, infekcija mokraćnih puteva, nazofaringitis
English: Sucrose
Croatian: Cork
English: Key efficacy results from Study 1 are summarised in Table 3.
Croatian: Ključni rezultati djelotvornosti iz Ispitivanja 1 sažeti su u Tablici 3. Tablica 3: Mjere ishoda djelotvornosti u Ispitivanju
English: Excipients: histidine, histidine hydrochloride monohydrate, polysorbate 80, sucrose.
Croatian: POPIS POMOĆNIH TVARI Pomoćne tvari: histidin, histidinklorid hidrat, polisorbat 80, saharoza.
English: SYLVANT passes into breast milk.
Croatian: • Nije poznato izlučuje li se SYLVANT u majčinom mlijeku.
English: Janssen Biologics B.V. Einsteinweg 101
Croatian: Janssen Biologics B.V.
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.
Croatian: 3,54 ± 0,44 ml/kg/dan i poluvrijeme je bilo 16,3 ± 4,2 dana.
English: A statistically significant difference (61.3% vs. 0% respectively; p = 0.0002) in the haemoglobin response in the siltuximab arm compared with the placebo arm was observed.
Croatian: U usporedbi s placebom, u skupini liječenoj siltuksimabom opažena je statistički značajna razlika (61,3% naspram 0%; p = 0,0002) u odgovoru hemoglobina.
English: Respiratory, thoracic and mediastinal disorders very common
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja vrlo često orofaringealna bol
English: • abnormal kidney function test
Croatian: • odstupanja u nalazima bubrežne funkcije