FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Efter den første administration af siltuximab (i doser fra 0,9 til 15 mg/kg) steg arealet under kurven for plasmakoncentration over tid (AUC) og maksimal serumkoncentration (Cmax) dosisproportionalt, og clearance (CL) var uafhængigt af dosis.
English: No dose adjustment is required (see section 5.2).
Danish: Dosisjustering er ikke nødvendig (se pkt.
English: Siltuximab has no or negligible influence on the ability to drive and use machines.
Danish: Siltuximab påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: • respiratory infections - such as of the nose, sinuses or throat
Danish: • luftvejsinfektioner - f.eks. i næse, bihuler eller svælg
English: The primary endpoint of the study was durable tumour and symptomatic response, defined as tumour response assessed by independent review and complete resolution or stabilisation of prospectively collected MCD symptoms, for at least 18 weeks without treatment failure.
Danish: Studiets primære endepunkt var varigt tumor- og symptomatisk respons, defineret som tumorrespons vurderet ved uvildig gennemgang og komplet resolution eller stabilisering af prospektivt indsamlede symptomer på MCD i mindst 18 uger uden behandlingssvigt.
English: 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).
Danish: Et åbent, ikke-randomiseret fase 2-multicenterstudie vurderede sikkerhed og virkning ved længerevarende behandling med siltuximab hos 60 patienter med MCD, som tidligere havde deltaget i studie 1 (41 patienter) eller studie 2 (19 patienter).
English: Haemoglobin response was defined as a change from baseline of ≥ 15 g/L (0.9 mmol/L) at Week 13.
Danish: Hæmoglobinrespons defineredes som en ændring fra baseline på ≥ 15 g/l (0,9 mmol/l) i uge 13.
English: Inspect the vials for particulate matter and discolouration prior to dose preparation.
Danish: Inspicer hætteglassene for partikelindhold og misfarvning før tilberedning af dosis.
English: Key efficacy results from Study 1 are summarised in Table 3.
Danish: De vigtigste resultater for virkning fra studie 1 fremgår af tabel 3.
English: • The active substance is siltuximab.
Danish: • Aktivt stof: siltuximab.
English: • The recommended dose is 11 milligrams per kilogram of body weight, given once every
Danish: • Den anbefalede dosis er 11 mg pr. kg legemsvægt, der gives en gang hver 3. uge.
English: The infusion should be completed within 6 hours of the addition of the reconstituted solution to the infusion bag.
Danish: Infusionen skal afsluttes inden for 6 timer efter tilsætning af den rekonstituerede opløsning til infusionsposen.
English: Signs include: cough, flu-like symptoms, feeling unwell, red or hot skin, fever.
Danish: Tegn omfatter: hoste, influenzalignende symptomer, utilpashed, rød eller varm hud, feber.
English: Siltuximab (9.2 and 46 mg/kg/week) did not produce any toxicity of the reproductive tract in cynomolgus monkeys.
Danish: Siltuximab (9,2 og 46 mg/kg/uge) medførte ikke toksicitet i reproduktionsorganerne hos cynomolgusaber.
English: By binding to IL-6, siltuximab blocks its activity and stops abnormal cell growth.
Danish: Gennem binding til IL6 blokerer siltuximab dets aktivitet og stopper unormal cellevækst.
English: • you have a condition such as stomach ulcer or diverticulitis that may increase the risk of getting a tear in the stomach or gut (gastrointestinal perforation).
Danish: • hvis du har en sygdom som f.eks. et mavesår eller betændelse i en eller flere divertikler (divertikulitis), der kan øge risikoen for at få en rift i din mave eller tarm (gastrointestinal perforering).
English: The percent change from baseline in MCD-related signs and symptoms and MCD-related overall symptom score at each cycle was calculated.
Danish: Den procentvise ændring fra baseline i MCD-relaterede symptomer og den samlede symptomscore relateret til sygdommen for hver behandlingscyklus blev beregnet.
English: MCD-related signs and symptoms were prospectively collected.
Danish: Symptomer relateret til MCD blev indsamlet prospektivt.
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.
Danish: Overproduktion af IL-6 i kroniske inflammatoriske sygdomme og maligniteter er sat i forbindelse med anæmi og kakeksi og der er fremsat en hypotese om, at det spiller en central rolle ved fremning af proliferation af plasmaceller og systemiske manifestationer hos patienter med CD.
English: The immunogenicity of siltuximab has been evaluated using antigen-bridging enzyme immunoassay (EIA) and electrochemiluminescence (ECL)-based immunoassay (ECLIA)
Danish: Siltuximabs immunogenicitet blev evalueret ved hjælp af metoderne antigen-bridging enzym-immunoassay (EIA) og elektrokemiluminiscens- (ECL-) baseret immunoassay (ECLIA).
English: It is well established that IL-6 stimulates the acute-phase expression of C-reactive protein (CRP).
Danish: Det er veldokumenteret, at IL-6 stimulerer eksprimering af C-reaktivt protein (CRP) i akutfasen.
English: (N/A; N/A)b
Danish: (IR; IR)b
English: • SYLVANT is supplied as a glass vial containing a white powder for concentrate for solution for infusion (powder for concentrate).
Danish: • SYLVANT udleveres i et hætteglas af glas, der indeholder et hvidt pulver til koncentrat til infusionsvæske, opløsning (pulver til koncentrat).
English: Symptoms of this disease may include feeling tired, sweating at night, having a tingling feeling, and loss of appetite.
Danish: Symptomerne på denne sygdom kan omfatte træthed, natlige svedudbrud, en prikkende fornemmelse og manglende appetit.
English: 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).
Danish: Den ordinerende læge bør også udvise forsigtighed ved samtidig administration af siltuximab og lægemidler, der er substrater for CYP3A4, hvis en nedsættelse af virkningen ville være uønsket (f.eks. orale kontraceptiva).
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
Danish: * Bedste understøttende behandling a 95 % konfidensinterval for forskellen i procentdele b IR = “Ikke relevant”, der var ingen respondere, hvorfor 95 % CI ikke er relevant c 95 % konfidensinterval for hazard ratio d Fuldstændigt symptomatisk respons defineres som 100 % reduktion i den samlede symptomscore for MCD ved baseline, der blev opretholdt i mindst 18 uger før behandlingssvigt
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.
Danish: Behandlingen med SYLVANT bør pauseres, hvis patienten har en svær infektion eller en svær ikke-hæmatologisk bivirkning, og den kan genoptages med samme dosis, når patienten er kommet sig.
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.
Danish: I overensstemmelse med halveringstiden efter den første dosis nåede serumkoncentrationer steady state ved den sjette infusion (med 3 ugers interval) med gennemsnitlige (± SD) maksimale og bundkoncentrationer på henholdsvis 332 ± 139 og 84 ± 66 mikrog/ml.
English: Gastrointestinal (GI) perforation has been reported in siltuximab clinical trials although not in MCD trials.
Danish: Der er rapporteret gastrointestinal (GI) perforering med siltuximab i kliniske studier, omend ikke i studier af MCD.
English: The population PK of siltuximab were analysed to evaluate the effects of demographic characteristics.
Danish: Siltuximabs populationsfarmakokinetik blev analyseret for at evaluere virkningerne af demografiske kendetegn.
English: In clinical studies, siltuximab was associated with an infusion related reaction or hypersensitivity reaction in 5.1% (severe reaction in 0.8%) of patients treated with siltuximab monotherapy.
Danish: I kliniske studier blev siltuximab associeret med en infusionsrelaret reaktion eller overfølsomhedsreaktion hos 5,1 % (svær reaktion hos 0,8 %) af de patienter, der fik siltuximab som monoterapi.
English: Effects of siltuximab on fertility have not been evaluated in humans.
Danish: Siltuximabs påvirkning af fertilitet er ikke evalueret hos mennesket.
English: 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.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med siltuximab seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: The MAH should provide tabulated data to the CHMP every 12 months in line with the periodic safety update report (PSUR) cycle including data for only those patients who are candidates for treatment with siltuximab.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende data i tabelform til CHMP hver 12. måned i lighed med cyklus for fremsendelse af periodiske, opdaterede sikkerhedsberetninger (PSUR'er), og tabellen må kun omfatte data for de patienter, der er kandidater til behandling med siltuximab.
English: 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.
Danish: IL-6 har vist sig at være involveret i forskellige normale fysiologiske processer såsom induktion af produktion af immunoglobulin, initiering af akutfase proteinsyntese i leveren og stimulering af den hæmatopoietiske prækursor for cellevækst og -differentiering.
English: The mechanism of action of siltuximab is neutralisation of IL-6 bioactivity, which can be measured indirectly by suppression of CRP.
Danish: Siltuximab virker gennem neutralisering af IL-6-bioaktivitet, som kan måles indirekte ved suppression af CRP.
English: During intravenous infusion of SYLVANT, mild to moderate infusion reactions may improve following slowing of or stopping the infusion.
Danish: Under intravenøs infusion af SYLVANT kan der opnås bedring af lette til moderate infusionsreaktioner, hvis infusionen gives langsommere eller stoppes helt.
English: During or following infusion, treatment should be discontinued in patients who have severe infusion related hypersensitivity reactions (e.g., anaphylaxis).
Danish: Under eller efter infusionen bør behandling seponeres hos patienter, der har svære overfølsomhedsreaktioner relateret til infusionen (f.eks. anafylaksi).
English: As with other immunoglobulin G antibodies, siltuximab crosses the placenta as observed in studies in monkeys.
Danish: Ligesom med andre immunglobulin G-antistoffer passerer siltuximab placenta, hvilket er observeret i studier med aber.
English: 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).
Danish: Efter administration af gentagne doser i den anbefalede dosering var clearance af siltuximab tidsuafhængigt, og der sås moderat systemisk akkumulering (et akumulationsindeks på 1,7).
English: Retreatment criteria
Danish: Kriterier for genbehandling
English: Evidence from studies conducted with siltuximab and other IL-6 inhibitors suggest that the potential for siltuximab to cause carcinogenicity is low.
Danish: Dokumentation fra studier udført med siltuximab og andre IL6-hæmnere indikerer, at siltuximab har et lavt potentiale for karcinogenicitet.
English: Study 2 In addition to Study 1, efficacy data are available in patients with CD from a single arm Phase 1 study
Danish: Ud over studie 1 foreligger der også effektdata for patienter med CD fra et fase 1-studie med en enkelt arm (studie 2).
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The effect of siltuximab on CYP450 enzyme activity can persist for several weeks after stopping therapy.
Danish: Siltuximabs påvirkning af CYP450-enzymaktivitet kan vare ved i flere uger efter behandlingsstop.
English: Studies in animals with siltuximab have shown no adverse effect on pregnancy or on embryofetal development (see section 5.3).
Danish: Dyrestudier af siltuximab indikerer ikke skadelige virkninger på graviditeten eller på den embryoføtale udvikling (se pkt.
English: • Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: • Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: • Use aseptic technique.
Danish: • Anvend en aseptisk teknik.
English: Select efficacy results from Study 1 in the hyaline vascular subgroup are summarised in Table 4.
Danish: Udvalgte effektresultater fra studie 1 i den hyaline vaskulære undergruppe er gengivet i tabel 4.
English: It is unknown whether siltuximab is excreted in human milk.
Danish: Det er ukendt, om silituximab udskilles i human mælk.
English: From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
Danish: Ud fra et mikrobiologisk synspunkt skal lægemidlet anvendes med det samme, med mindre metoden for åbning/rekonstitution/fortynding udelukker risiko for mikrobiel forurening.
English: Siltuximab is a monoclonal antibody (a specialised type of protein) that binds selectively to an antigen (a target protein) in the body called interleukin-6 (IL-6).
Danish: Siltuximab er et monoklonalt antistof (en særlig type protein), der binder selektivt til et antigen (et målprotein) i kroppen, det såkaldte interleukin-6 (IL6).
English: The effect of anti-siltuximab antibody status was not examined, as there were insufficient numbers of anti-siltuximab antibody positive patients.
Danish: Virkningen af status for anti-siltuximab-antistoffer er ikke undersøgt, da antallet af patienter, der var positive for anti-siltuximab-antistoffer, var utilstrækkeligt.
English: a SYLVANT may increase haemoglobin levels in MCD patients
Danish: a SYLVANT kan øge hæmoglobinniveauet hos patienter med MCD.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver angivet hyppighed anføres bivirkningerne efter, hvor alvorlige de er.
English: Arthralgia, pain in extremity
Danish: Artralgi, smerter i ekstremiteter
English: • joint pain, arm or leg pain
Danish: • ledsmerter, smerter i arme eller ben
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.
Danish: Derfor vil administration af siltuximab sammen med substrater for CYP450, der har et snævert terapeutisk indeks, potentielt kunne ændre terapeutiske virkninger og toksicitet af disse lægemidler på grund af ændringen af CYP450-metabolismen.
English: Multicentric Castleman's disease causes benign tumours (non-cancerous growths) to develop in the lymph nodes in the body.
Danish: Multicentrisk Castlemans sygdom fører til udvikling af godartede tumorer (svulster der ikke skyldes kræft) i kroppens lymfeknuder.
English: Table 3: Efficacy endpoints from study 1 Efficacy endpoints
Danish: Tabel 3: Endepunkter for effekt fra studie 1 Endepunkter for effekt
English: No major age-related differences in pharmacokinetics (PK) or in safety profile were observed in clinical studies.
Danish: I kliniske studier sås ingen større aldersrelaterede forskelle i farmakokinetik (PK) eller i sikkerhedsprofil.
English: As this medicine will be given to you by your doctor or nurse, it is unlikely that you will be given too much.
Danish: Behandlingen med SYLVANT gives af en læge eller sygeplejerske, og det er ikke sandsynligt, at du får for meget.
English: In Study 1 a statistically significant difference in independently reviewed durable tumour and symptomatic response rate in the siltuximab arm compared with the placebo arm (34% vs. 0%, respectively; 95% CI: 11.1, 54.8; p = 0.0012) was observed.
Danish: I studie 1 blev der observeret en statistisk signifikant forskel ved uvildig gennemgang af varige responsrater for tumorer og symptomer i siltuximabarmen sammenlignet med placeboarmen (henholdsvis 34 % og 0 %; 95 % CI: 11,1, 54,8, p = 0,0012).
English: ECOG performance status score (0/1/2) at baseline was 42%/45%/13% in the siltuximab arm and 39%/62%/0% in the placebo arm, respectively.
Danish: Scoring for ECOG-funktionsniveau (0/1/2) ved baseline var henholdsvis 42 %/45 %/13 % i siltuximabarmen og 39 %/62 %/0 % i placeboarmen.
English: SYLVANT is used to treat multicentric Castleman's disease (MCD) in adult patients who do not have human immunodeficiency virus (HIV) or human herpesvirus-8 (HHV-8) infection.
Danish: SYLVANT anvendes til behandling af multicentrisk Castlemans sygdom (MCD) hos voksne patienter, der ikke er smittet med human immundefektvirus (hiv) eller human herpesvirus-8 (HHV-8).
English: Binding bioactive IL-6 by siltuximab may result in increased metabolism of CYP450 substrates, because CYP450 enzyme activity will normalise.
Danish: Når bioaktivt IL-6 bindes af siltuximab, kan det resultere i øget metabolisme af substrater for CYP450, eftersom CYP450-enzymaktivitet normaliseres.
English: Immune system disorders common
Danish: Immunsystemet Almindelige
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.
Danish: Komplet symptomatisk respons defineredes som en 100 % reduktion af den samlede symptomscore ved baseline for MCD, der varede ved i mindst 18 uger før behandlingssvigt
English: In long-term treatment of MCD patients with siltuximab at the recommended dosage of 11 mg/kg every 3 weeks, infusion related reactions or hypersensitivity reactions occurred at a frequency of 6.3% (1.3% for severe reactions).
Danish: Ved langtidsbehandling af MCD-patienter med siltuximab ved den anbefalede dosering på 11 mg/kg hver 3. uge forekom der infusionsrelaterede reaktioner eller overfølsomhedsreaktioner med en hyppighed på 6,3 % (svær reaktion hos 1,3 %).
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.
Danish: Hos patienter med baseline-ALATop til 3,7 gange den øvre grænse for normalområdet, baseline-albumin i området 15 til 58 g/l og baseline-bilirubin i området 1,7 til 42,8 mg/dl sås ingen betydningsfuld påvirkning af siltuximabs farmakokinetik.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Det er især vigtigt, at du fortæller det til lægen eller apotekspersonalet, hvis du tager et af følgende lægemidler:
English: Siltuximab crossed the placenta during gestation whereby fetal serum concentrations of siltuximab at gestation day (GD) 140 were similar to maternal concentrations.
Danish: Siltuximab passerede placenta under drægtigheden, hvorved føtale serumkoncentrationer på drægtighedsdag (GD) 140 svarede til koncentrationerne hos moderdyret.
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)]
Danish: Vægtstigning a Alle patienter med Castlemans sygdom, som fik siltuximab i den anbefalede dosering på 11 mg/kg hver 3. uge [inklusive patienter der skiftede behandling (crossover) (N = 87)]
English: What you need to know before you are given SYLVANT You should not be given SYLVANT if:
Danish: Det skal du vide, før du begynder at bruge SYLVANT Du må ikke få SYLVANT:
English: In this study, 16 of the 35 MCD patients were hyaline vascular subtype; 31% of these patients had a radiologic response based on independent review and 88% showed clinical benefit response as defined in the protocol.
Danish: Af disse patienter havde 31 % radiologisk respons baseret på en uvildig gennemgang, og 88 % responderede klinisk som defineret i protokollen.
English: Upon initation or discontinuation of siltuximab in patients being treated with concomitant medicinal products that are CYP450 substrates and have a narrow therapeutic index, monitoring of the effect (e.g., warfarin) or concentration of medicinal product (e.g., cyclosporine or theophylline) is recommended.
Danish: Efter initiering eller seponering af SYLVANT hos patienter i behandling med lægemidler, der er substrater for CYP450 og har et snævert terapeutisk indeks, ambefales monitorering af virkningen (f.eks. ved warfarin) eller koncentrationen af lægemidlet (f.eks. ciclosporin eller theophyllin).
English: 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.
Danish: Incidensen af påviselige anti-siltuximab-antistoffer var samlet set 0,9 % (4/432) og 2,1 % (4/189) for patienter med mindst én prøve testet med den høj lægemiddel tolerante ECLIA-analysemetode.
English: Histidine hydrochloride monohydrate Polysorbate 80
Danish: Histidinhydrochloridmonohydrat Polysorbat 80
English: 200 Great Valley Parkway Malvern
Danish: Janssen Biotech Inc. 200 Great Valley Parkway Malvern
English: Siltuximab is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Siltuximab bør ikke anvendes under graviditeten eller til kvinder i den fertile alder der ikke anvender kontraception.
English: No evidence of altered safety or efficacy was identified in the patients who developed antibodies to siltuximab.
Danish: Der er ikke påvist ændret sikkerheds- eller virkningsprofil hos de patienter, der udviklede antistoffer mod siltuximab.
English: Measurement of IL-6 concentrations in serum or plasma during treatment should not be used as a pharmacodynamic marker, as siltuximab-neutralised antibody-IL-6 complexes interfere with current immunological-based IL-6 quantification methods.
Danish: Under behandlingen bør måling af IL-6-koncentrationer i serum eller plasma ikke anvendes som farmakodynamisk markør, da siltuximab-neutraliserede antistof-IL-6-komplekser interfererer med aktuelle immunologiske metoder til kvantificering af IL-6.
English: The recommended dose is 11 mg/kg siltuximab given over 1 hour as an intravenous infusion administered every 3 weeks until treatment failure.
Danish: Den anbefalede dosering af siltuximab er 11 mg/kg indgivet over 1 time som intravenøs infusion, der administreres hver 3. uge indtil behandlingsvigt.