FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: I løbet af et embryoføtalt udviklingsstudie, hvor siltuximab blev administreret intravenøst til drægtige cynomolgusaber (drægtighedsdag 20-118) i doser på 9,2 og 46 mg/kg/uge blev der ikke observeret toksicitet hos moderdyr eller foster.
English: Paediatric population The safety and efficacy of siltuximab have not been established in paediatric patients.
Danish: Pædiatrisk population Siltuximabs sikkerhed og virkning er ikke klarlagt hos pædiatriske patienter.
English: 16 patients with MCD treated with 11 mg/kg every 3 weeks, overall tumour response rate by independent review was 43.8% with 6.3% complete response.
Danish: Hos de 16 patienter med MCD, der fik 11 mg/kg hver 3. uge, var den samlede tumorresponsrate ifølge en uvildig gennemgang 43,8 % med 6,3 % komplet respons.
English: Median duration of siltuximab treatment was 5.52 years (range: 0.8 to 10.8 years); more than 50% of patients received siltuximab treatment for ≥5 years.
Danish: Den mediane varighed af behandling med siltuximab var 5,52 år (interval: 0,8 til 10,8 år).
English: Contents of the pack and other information What SYLVANT contains
Danish: Pakningsstørrelser og yderligere oplysninger SYLVANT indholder
English: Table 4: Select efficacy endpoints for hyaline vascular subgroup from study 1 Efficacy endpoints
Danish: Tabel 4: Udvalgte endepunkter for effekt for den hyaline vaskulære undergruppe fra studie 1
English: Slowly add the total volume of reconstituted SYLVANT solution to the 250 mL infusion bag.
Danish: Langsomt tilsæt den samlede mængde rekonstitueret SYLVANT-opløsning til 250 ml-infusionsposen.
English: Metabolism and nutrition disorders very common
Danish: Metabolisme og ernæring Meget almindelige
English: Biomarkers
Danish: Biomarkører
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.
Danish: Der sås en mindre reduktion af T-celleafhængigt antistofrespons og et fald i størrelsen på miltens germinalcentre efter Keyhole limpet hemocyanin- (KLH-)immunisering, som ansås for at være farmakologisk respons på IL6-hæmning og uden toksikologisk betydning.
English: 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.
Danish: Administrer den fortyndede opløsning over 1 time ved hjælp af administrationssæt foret med PVC eller polyurethan (PU) eller PE, der indeholder et indbygget filter med 0.2-micron inline polyethersulfon (PES).
English: - If you get any side effects, talk to your doctor, pharmacist, or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Upper respiratory tract infection, urinary tract infection, nasopharyngitis
Danish: Øvre luftvejsinfektion, urinvejsinfektion, nasofaryngitis
English: Duration of tumour & symptomatic response (days) - independent review; median (min, max)
Danish: Varighed af varigt komplet symptomatisk respons (dage) - uvildig gennemgang; median (min, max)
English: The effects of various covariates on siltuximab PK were assessed in the analyses.
Danish: Virkningerne af forskellige kovariater på siltuximabs farmakokinetik blev vurderet i analyserne.
English: Chemical and physical in-use stability has been demonstrated for up to 8 hours at room temperature (see section 6.6).
Danish: Efter rekonstitution og fortynding Kemisk og fysisk holdbarhed er påvist i op til 8 timer ved stuetemperatur (se pkt.
English: Upon resolution of the reaction, reinitiating the infusion at a lower infusion rate and therapeutic administration of antihistamines, acetaminophen, and corticosteroids may be considered.
Danish: Når reaktionen ophører, kan det overvejes at genoptage infusionen med langsommere hastighed, samt at behandle med antihistaminer, paracetamol og kortikosteroider.
English: • swelling in the arms, legs, neck or face
Danish: • hævelser i arme, ben, hals eller ansigt
English: Siltuximab is a chimeric (human-murine) immunoglobulin G1κ (IgG1κ) monoclonal antibody produced in a Chinese hamster ovary (CHO) cell line by recombinant DNA technology.
Danish: Siltuximab er et kimært (humant-murint) immunglobulin G1κ- (IgG1κ-) monoklonalt antistof fremstillet i ovarieceller fra kinesiske hamstere (CHO) med rekombinant DNA-teknologi.
English: Siltuximab is a human-mouse chimeric monoclonal antibody that forms high affinity, stable complexes with soluble bioactive forms of human IL-6.
Danish: Siltuximab er et humant-murint kimært monoklonalt antistof, der danner stabile komplekser med høj affinitet med opløselige bioaktive former af humant IL-6.
English: Talk to your doctor, pharmacist or nurse if you notice any of the following side effects:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, hvis du bemærker en af følgende bivirkninger:
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.
Danish: Der sås en statistisk signifikant forskel (henholdsvis 61,3 % vs. 0 %, p=0,0002) i hæmoglobinrespons i siltuximabarmen ved sammenligning med placeboarmen.
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).
Danish: Tabel 2 viser hyppigheden af de påviste bivirkninger hos de 87 patienter med MCD (studie 1, studie 2 og studie 3), der blev behandlet med den anbefalede dosering på 11 mg/kg hver 3. uge (yderligere oplysninger er angivet i pkt.
English: Secondary efficacy endpoints
Danish: Sekundære endepunkter for effekt
English: Nervous system disorders very common
Danish: Nervesystemet Meget almindelige
English: Blood and lymphatic system disorders very common
Danish: Blod og lymfesystem Meget almindelige
English: Cross-study population PK analyses were performed using data from 378 patients with a variety of conditions who received single-agent siltuximab at doses ranging from 0.9 to 15 mg/kg.
Danish: Der blev udført populationsfarmakokinetiske analyser på tværs af studierne af data fra 378 patienter med forskellige lidelser, der fik siltuximab som monoterapi i doser fra 0,9 til 15 mg/kg.
English: Do not use if visibly opaque or if foreign particles and/or solution discolouration are present.
Danish: Må ikke anvendes, hvis opløsningen er synligt uigennemsigtig, eller hvis den indeholder fremmedlegemer og/eller er misfarvet.
English: The European Medicines Agency has waived the obligation to submit the results of studies with siltuximab in all subsets of the paediatric population in CD (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med siltuximab i en eller flere undergrupper af den pædiatriske population ved CD (se pkt.
English: • No physical biochemical compatibility studies have been conducted to evaluate the co-administration of SYLVANT with other medicinal products.
Danish: • Der er ikke udført studier af fysisk og kemisk forligelighed for at evaluere co-administration af SYLVANT og andre lægemidler.
English: Nausea, abdominal pain, vomiting, constipation, diarrhoea, gastroesophageal reflux disease, mouth ulceration
Danish: Kvalme, abdominalsmerter, opkastning, obstipation, diarré, gastroøsofageal refluks, mundsår
English: Do not use if you see opaque or foreign particles and/or if the solution appears discoloured after reconstitution.
Danish: Må ikke anvendes, hvis opløsningen er uigennemsigtig eller indeholder fremmedlegemer, og/eller hvis opløsningen fremstår misfarvet efter tilberedning.
English: Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen, apotekspersonalet eller sundhedspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
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.
Danish: Siltuximab hindrer humant IL-6 i at binde sig til både opløselige og membranbundne IL-6-receptorer (IL-6R), hvorved det hæmmer dannelsen af det heksametriske signalkompleks med gp130 på celleoverfladen.
English: Table 2 lists adverse reactions observed in MCD patients treated with siltuximab at the recommended dosage of 11 mg/kg every 3 weeks.
Danish: I tabel 2 angives de bivirkninger, der blev observeret hos patienter med MCD, der fik siltuximab i den anbefalede dosering på 11 mg/kg hver 3. uge.
English: What SYLVANT is and what it is used for What SYLVANT is
Danish: Virkning og anvendelse Hvad er SYLVANT?
English: The repeat-dose toxicology studies conducted in young cynomolgus monkeys at doses of 9.2 and 46 mg/kg/week (up to 22-fold greater exposure than in patients receiving 11 mg/kg every 3 weeks) with siltuximab showed no signs indicative of toxicity.
Danish: I toksikologistudier med gentagne doser udført i unge cynomolgusaber, der fik siltuximab i doser på 9,2 og 46 mg/kg/uge (dvs. en eksponering der var op til 22 gange større end hos patienter, der fik 11 mg/kg hver 3. uger), sås ingen indikationer på toksicitet.
English: • drop in the number of platelets (thrombocytopenia)
Danish: • et fald i antallet af blodplader (trombocytopeni)
English: • The reconstituted solution should be kept for no more than 2 hours prior to addition into the intravenous bag.
Danish: • Den rekonstituerede opløsning bør ikke opbevares i over 2 timer, før det tilsættes infusionsposen.
English: Available non-clinical data do not suggest an effect on fertility under siltuximab treatment (see section 5.3).
Danish: De foreliggende prækliniske data indikerer ikke påvirkning af fertilitet under behandling med siltuximab (se pkt.
English: Best tumour response (investigator assessment)
Danish: Bedste tumorrespons (investigators vurdering)
English: • urinary tract infection
Danish: • urinvejsinfektion
English: SYLVANT 400 mg powder for concentrate for solution for infusion EU/1/14/928/002
Danish: SYLVANT 400 mg pulver til koncentrat til infusionsvæske, opløsning EU/1/14/928/002
English: • weight gain.
Danish: • vægtstigning
English: • The other ingredients (excipients) are histidine, histidine hydrochloride monohydrate, polysorbate 80, and sucrose.
Danish: • Øvrige indholdsstoffer (hjælpestoffer): Histidin, histidinhydrochloridmonohydrat, polysorbat 80 og saccharose.
English: Do not infuse SYLVANT concomitantly in the same intravenous line with other agents.
Danish: SYLVANT må ikke infunderes i det samme intravenøse drop som andre lægemidler.
English: Haemoglobin increase > 15 g/L (0.9 mmol/L) at Week 13/haemoglobin response-evaluable population
Danish: Hæmoglobinstigning > 15 g/l (0,9 mmol/l) i uge 13/hæmoglobinrespons evaluerbar population
English: A Phase 2, multinational, randomised (2:1) double-blind, placebo-controlled study was conducted to assess the efficacy and safety of siltuximab (11 mg/kg every 3 weeks) compared with placebo in combination with best supportive care in patients with MCD.
Danish: For at vurdere siltuximabs virkning og sikkerhed (11 mg/kg hver 3. uge) blev der udført et multinationalt, randomiseret (2:1) dobbeltblindt, placebokontrolleret fase 2-studie ved sammenligning med placebo i kombination med den bedste understøttende behandling af patienter med MCD.
English: No physical biochemical compatibility studies have been conducted to evaluate the co-administration of SYLVANT with other medicinal products.
Danish: Der er ikke udført studier af fysisk og kemisk forligelighed for at evaluere co-administration af SYLVANT og andre lægemidler.
English: • high fat levels in your blood (hypertriglyceridaemia)
Danish: • forhøjet indhold af fedtstoffer i blodet (hypertriglyceridæmi)
English: • Calculate the dose, total volume of reconstituted SYLVANT solution required and the number of vials needed.
Danish: • Beregn dosis, den fornødne samlede mængde af rekonstitueret SYLVANT-opløsning og det nødvendige antal hætteglas.
English: SYLVANT 100 mg powder for concentrate for solution for infusion EU/1/14/928/001
Danish: SYLVANT 100 mg pulver til koncentrat til infusionsvæske, opløsning EU/1/14/928/001
English: Table 2: Adverse reactions in siltuximab treated patients in MCD clinical studies a
Danish: Tabel 2: Bivirkninger hos patienter behandlet med siltuximab i kliniske studier af MCDa Systemorganklasse
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).
Danish: Den mediane alder var 47 år (20-74) i siltuximab-armen og 48 år (27-78) i placeboarmen.
English: • oral contraceptives, used to prevent pregnancy.
Danish: • p-piller og minipiller til at forebygge graviditet.
English: Calculate the dose, total volume of reconstituted SYLVANT solution required and the number of vials needed.
Danish: Beregn dosis, den fornødne samlede mængde af rekonstitueret SYLVANT-opløsning og det nødvendige antal hætteglas.
English: • Gently swirl (DO NOT SHAKE OR VORTEX OR SWIRL VIGOROUSLY) the reconstituted vials to aid the dissolution of the powder.
Danish: • Vip forsigtigt de rekonstituerede hætteglas (UNDGÅ AT RYSTE ELLER HVIRVLE ELLER VIPPE KRAFTIGT) for at fremme opløsningen af pulveret.
English: Skin and subcutaneous tissue disorders very common
Danish: Hud og subkutane væv Meget almindelige
English: After reconstitution the solution contains 20 mg siltuximab per mL.
Danish: Efter rekonstitution indeholder opløsningen 20 mg siltuximab pr. ml.
English: Promptly evaluate patients presenting with symptoms that may be associated with or suggestive of GI perforation.
Danish: Patienter med symptomer, der kan sættes i forbindelse med eller tyder på GI-perforering, skal vurderes akut.
English: Talk to your doctor, pharmacist, or nurse before you are given SYLVANT if:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger SYLVANT:
English: • Allow vial(s) of SYLVANT to come to room temperature (15°C to 25°C) over approximately 30 minutes.
Danish: • Lad hætteglas med SYLVANT stå fremme i ca. 30 minutter, så de opnår stuetemperatur (15 °C til 25 °C).
English: Decreases in total IgG, IgA, or IgM levels below normal were observed in the range of 4 to 11%
Danish: Der sås fald i total IgG, IgA eller IgM til under normalniveauet hos i størrelsesordenen 4 - 11 % af patienterne i MCD-studiet (studie 1).
English: Interleukin-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T-cells and B-cells,
Danish: Interleukin-6 er et pleiotropisk pro-inflammatorisk cytokin, der dannes af en lang række celletyper inklusive T-celler og B-celler, lymfocytter, monocytter og fibroblaster samt maligne celler.
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.
Danish: • Fortynd den samlede mængde af den rekonstituerede dosis opløsning til 250 ml med steril glucose 5 % ved at trække en mængde svarende til mængden af rekonstitueret SYLVANT op fra posen med 250 ml glucose 5 %.
English: • high level of 'uric acid' in the blood, which may cause gout
Danish: • forhøjet indhold af urinsyre i blodet, som kan give urinsyregigt
English: HR 0.418
Danish: 134 dage 0,0084; HR 0,418
English: Other medicines and SYLVANT
Danish: Brug af anden medicin sammen med SYLVANT
English: Gently swirl (DO NOT SHAKE OR VORTEX OR SWIRL VIGOROUSLY) the reconstituted vials to aid the dissolution of the powder.
Danish: Vip forsigtigt de rekonstituerede hætteglas (UNDGÅ AT RYSTE ELLER HVIRVLE ELLER VIPPE KRAFTIGT) for at fremme opløsningen af pulveret.
English: Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Svær overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Excipients: histidine, histidine hydrochloride monohydrate, polysorbate 80, sucrose.
Danish: Hjælpestoffer: histidin, histidinhydrochloridmonohydrat, polysorbat 80, saccharose.
English: A consistent treatment effect favouring siltuximab treated patients across all major secondary endpoints was shown in the hyaline vascular subgroup.
Danish: I den hyaline vaskulære subtype sås en konsistent behandlingseffekt til fordel for siltuximabbehandlede patienter for alle væsentlige sekundære endepunkter.
English: Infections and infestations very common
Danish: Infektioner og parasitære sygdomme Meget almindelige
English: • stomach pain or discomfort, constipation, diarrhoea, heartburn, ulcers (sores) in the mouth,
Danish: • mavepine eller -ubehag, forstoppelse, diarré, halsbrand, sår i munden, kvalme, opkastning
English: It is not known if SYLVANT is safe and effective in this population, therefore SYLVANT should not be given to children and adolescents.
Danish: Det vides ikke, om SYLVANT er sikkert og effektivt hos denne population.
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.
Danish: Fortynd den samlede mængde af den rekonstituerede dosis opløsning til 250 ml med steril glucose 5 % ved at trække en mængde svarende til mængden af rekonstitueret SYLVANT op fra posen med 250 ml glucose 5 %.
English: Allow vial(s) of SYLVANT to come to room temperature (15°C to 25°C) over approximately 30 minutes.
Danish: Lad hætteglas med SYLVANT stå fremme i ca. 30 minutter, så de opnår stuetemperatur (15 °C til 25 °C).
English: Durable tumour & symptomatic response (investigator review) Best tumour response (independent review)
Danish: Varigt tumor- og symptomatisk respons (investigators gennemgang) Bedste tumorrespons (uvildig gennemgang)
English: How SYLVANT works
Danish: Sådan virker SYLVANT
English: Serious infections, including pneumonia and sepsis, were observed during clinical studies (see section 4.8).
Danish: I kliniske studier observeredes alvorlige infektioner, herunder pneumoni og sepsis (se pkt.
English: The reconstituted solution should be kept for no more than 2 hours prior to addition into the intravenous bag.
Danish: Den rekonstituerede opløsning bør ikke opbevares i over 2 timer, før det tilsættes infusionsposen.
English: Respiratory, thoracic and mediastinal disorders very common
Danish: Luftveje, thorax og mediastinum Meget almindelige
English: Medicinal products subject to restricted medical prescription (See Annex I: Summary of Product
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: General disorders and administration site conditions very common
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelige
English: • severe allergic reaction - the signs may include: difficulty breathing, chest tightness, wheezing,
Danish: • alvorlig allergisk reaktion - symptomerne kan omfatte besvær med at trække vejret, trykken for brystet, hvæsende åndedræt, alvorlig svimmelhed eller omtågethed, hævelser i læberne eller hududslæt.
English: Janssen Biotech Inc.
Danish: Janssen Biologics B.V.
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.
Danish: I dyrkede humane hepatomaceller sås dosisafhængig hæmning af IL-6-stimuleret produktion af akutfaseproteinet serumamyloid A med siltuximab.
English: Signs include: difficulty breathing, chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash.
Danish: Symptomerne kan omfatte vejrtrækningsbesvær, trykken for brystet, hvæsende åndedræt, alvorlig svimmelhed eller uklarhed, hævede læber eller hududslæt.
English: No formal studies have been conducted to investigate the PK of siltuximab in patients with renal or hepatic impairment (see section 4.4).
Danish: Der er ikke udført formelle studier af siltuximabs farmakokinetik hos patienter med nedsat nyre- eller leverfunktion (se pkt.
English: SYLVANT should remain at room temperature for the duration of the preparation.
Danish: Under hele tilberedningen skal SYLVANT befinde sig ved stuetemperatur.
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.
Danish: I kliniske studier, der omfattede studier af monoterapi og kombinationsbehandling, blev prøver fra i alt 432 patienter testet for antiantistoffer mod siltuximab, og 189 patienter fik mindst én prøve testet med en høj lægemiddel tolerant ECLIA-analysemetode.
English: Siltuximab+BSC* Placebo+BSC P-valuea
Danish: Siltuximab+BSC*
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).
Danish: Den anbefalede kanyle til tilberedningen er 21 gauge 38 mm. Infusionsposerne (250 ml) skal indeholde glucose 5 % og skal være fremstillet af polyvinylchlorid (PVC) eller polyolefin (PO), eller polypropylen (PP), eller polyethylen (PE).
English: Rodent carcinogenicity studies have not been conducted with siltuximab.
Danish: Der er ikke udført karcinogenicitetsstudier med siltuximab hos gnavere.
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.
Danish: In vitro hæmmede siltuximab dosisafhængigt væksten af en IL-6-afhængig plasmacytomacellelinje i mus som reaktion på humant IL-6.
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.
Danish: Indlægsseddel: Information til patienten SYLVANT 100 mg pulver til koncentrat til infusionsvæske, opløsning siltuximab Dette lægemiddel er underlagt supplerende overvågning.
English: Package leaflet: Information for the patient SYLVANT 400 mg powder for concentrate for solution for infusion siltuximab This medicine is subject to additional monitoring.
Danish: Indlægsseddel: Information til patienten SYLVANT 400 mg pulver til koncentrat til infusionsvæske, opløsning siltuximab Dette lægemiddel er underlagt supplerende overvågning.
English: SYLVANT-treated patients with known hepatic impairment as well as patients with elevated transaminase or bilirubin levels should be monitored.
Danish: Det anbefales at monitorere patienter med kendt nedsat leverfunktion og patienter med forhøjede transaminaser eller bilirubin, som behandles med SYLVANT.
English: • SYLVANT is not recommended for use during pregnancy.
Danish: • SYLVANT bør ikke anvendes af kvinder, der ammer.
English: Localised oedema
Danish: Lokalt ødem
English: SYLVANT is not likely to affect your ability to drive, cycle, or use any tools or machines.
Danish: SYLVANT påvirker sandsynligvis ikke arbejdssikkerheden eller din evne til at færdes i trafikken.
English: Rash, pruritus, eczema
Danish: Udslæt, pruritus, eksem
English: Hypertriglyceridaemia, hyperuricaemia common
Danish: Hypertriglyceridæmi, hyperurikæmi
English: Durable tumour & symptomatic response (investigator review)
Danish: Varigt tumor- og symptomatisk respons (investigators gennemgang)