FrancophonIA/ELRC3.0 huggingface dataset:
English: If Kineret treatment is continued during serious infections to reduce the risk for a disease flare, careful monitoring is required.
Danish: Hvis behandlingen med Kineret fortsættes under alvorlige infektioner for at reducere risikoen for, at sygdommen blusser op, er nøje overvågning nødvendig.
English: To give yourself or your child a subcutaneous injection you will need:
Danish: For at give Dem selv eller Deres barn en subkutan injektion skal De bruge:
English: Kineret is injected just under the skin.
Danish: Kineret injiceres lige under huden.
English: The 50 patients who achieved a clinical response after a 12-week open-label run-in were randomized to Kineret (25 patients) or placebo (25 patients), administered daily for an additional 16 weeks.
Danish: De 50 patienter, der opnåede et klinisk respons efter en 12-ugers open-label indkøring, blev randomiseret til Kineret (25 patienter) eller placebo (25 patienter), administreret dagligt i yderligere 16 uger.
English: Anakinra neutralises the biologic activity of interleukin-1α (IL-1α) and interleukin-1β (IL-1β) by competitively inhibiting their binding to interleukin-1 type I receptor (IL-1RI).
Danish: Anakinra neutraliserer den biologiske aktivitet af interleukin-1α (IL-1α) og interleukin-1β (IL-1β) ved kompetitiv hæmning af bindingen til interleukin-1 type I receptor (IL-1RI).
English: • Patient identification
Danish: • Patientidentifikation
English: Most patients continued on study medicinal product after the infection resolved.
Danish: De fleste patienter fortsatte med forsøgsmedicinen, efter infektionen var behandlet.
English: If a severe allergic reaction occurs, administration of Kineret should be discontinued and appropriate treatment initiated.
Danish: Hvis en alvorlig allergisk reaktion forekommer, skal Kineret seponeres og passende behandling initieres.
English: However, any of the following symptoms may indicate an allergic reaction to Kineret, so you should seek immediate medical attention.
Danish: Følgende kan dog være symptomer på en allergisk reaktion på Kineret, og De skal straks søge lægebehandling.
English: This could mean that the doses of some other medicines, e.g. warfarin or phenytoin, have to be adjusted.
Danish: Dette kan medføre, at doseringen af visse andre lægemidler som f.eks. warfarin skal justeres.
English: The occurrence of antibodies was typically transient and not associated with clinical adverse reactions or diminished efficacy.
Danish: Forekomsten af antistoffer var typisk forbigående og ikke forbundet med kliniske bivirkninger eller reduceret virkning.
English: No effects on embryo-foetal development in the rabbit were observed at doses 100 times the human dose.
Danish: Der er ikke observeret nogen effekt på embryo/fosterudviklingen hos kaniner ved doser 100 gange den humane dosis.
English: 16 patients completed the subsequent open label phase and among 7 responders at month 12, 6 had stopped glucocorticoid treatment and 5 of them had inactive disease.
Danish: 16 patienter gennemførte den efterfølgende open-label fase, og blandt 7 respondere ved måned 12 havde 6 stoppet glukokortikoidbehandlingen, og 5 af dem havde inaktiv sygdom.
English: Only use each syringe for one injection.
Danish: Anvend kun injektionssprøjten til én injektion.
English: The safety profile in paediatric patients was similar to that seen in adult populations and no clinically relevant new adverse reactions were seen.
Danish: Sikkerhedsprofilen hos pædiatriske patienter svarede til den, der ses hos voksne populationer, og der sås ingen klinisk relevante nye utilsigtede reaktioner.
English: • Instructions on correct injection procedures and disposal of used syringes
Danish: • Vejledning i korrekte injektionsprocedurer og bortskaffelse af brugte sprøjter
English: Interleukin-1 (IL-1) is a pivotal pro-inflammatory cytokine mediating many cellular responses including those important in synovial inflammation.
Danish: Interleukin-1 (IL-1) er et pivotalt pro-inflammatorisk cytokin, som medierer mange cellulære responser inklusiv dem, som er vigtige ved synovial inflammation.
English: Less than 2.5% of the administered dose of Kineret was removed by hemodialysis or continuous ambulatory peritoneal dialysis.
Danish: Mindre end 2,5% af den administrerede Kineret-dosis blev fjernet med hæmodialyse eller kontinuert, ambulant peritonealdialyse.
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Danish: Bivirkningerne er angivet i overensstemmelse med MedDRA-systemorganklasserne og hyppighedskategori.
English: Thus, it may be expected that for an IL-1 receptor antagonist, such as anakinra, the formation of CYP450 enzymes could be normalized during treatment.
Danish: I tilfælde af en IL-1-antagonist som anakinra kunne det således forventes, at dannelsen af CYP450-enzymet skulle kunne normaliseres under behandling.
English: Make sure you know what Kineret dose your doctor has prescribed; 20 to 90 mg, 100 mg or higher.
Danish: Sørg for, at De er klar over, hvilken Kineret-dosis, Deres læge har ordineret: 20 til 90 mg, 100 mg eller derover.
English: Population pharmacokinetic analysis demonstrated that the mean plasma clearance value after subcutaneous bolus administration was approximately 14% higher in men than in women and approximately 10% higher in subjects < 65 years than in subjects ≥ 65 years.
Danish: Farmakokinetiske populationsanalyser viser at gennemsnitsværdien for plasmaclearance efter subkutan bolusadministration var cirka 14% større hos mænd end hos kvinder og cirka 10% større hos forsøgspersoner <65 år end hos forsøgspersoner ≥65 år.
English: Pharmacokinetic data are lacking in older CAPS patients.
Danish: Der mangler farmakokinetiske data for ældre CAPS-patienter.
English: In studies of sepsis, 1,015 patients received Kineret at doses up to 2 mg/kg/hour i.v.
Danish: I undersøgelser af sepsis modtog 1.015 patienter Kineret i doser på op til 2 mg/kg/time i.v.
English: Do not remove the cover from the syringe until you are ready to inject.
Danish: Fjern ikke hætten fra sprøjten, før De er klar til at foretage injektionen.
English: This results in harmful effects leading to inflammation, causing the symptoms of the disease.
Danish: Dette har skadelige virkninger, der fører til betændelsestilstande (inflammation), der forårsager sygdommens symptomer.
English: CIAS1/NLRP3 encodes for cryopyrin, a component of the inflammasome.
Danish: CIAS1/NLRP3 koder for cryopyrin, en komponent i inflammasomet.
English: You do not have to remove the air bubble before injecting.
Danish: De behøver ikke at fjerne luftboblerne, før De injicerer Dem.
English: The ejected liquid will be absorbed by the gauze or tissue as shown in Figure C.
Danish: Den overskydende væske absorberes af gazen eller servietten som vist i figur C.
English: None of the syringe or needle shield components are made with natural rubber latex.
Danish: Ingen af komponenterne i sprøjten eller kanylebeskyttelsen er lavet af naturlig gummilatex.
English: The efficacy and safety of Kineret in patients with AST/ALT ≥ 1.5 x upper level of normal have not been evaluated.
Danish: Kinerets virkning og sikkerhed hos patienter med AST/ALT ≥1,5 x øvre normalniveau er ikke blevet evalueret.
English: The safety of Kineret in individuals with latent tuberculosis is unknown.
Danish: Kinerets sikkerhed hos personer med latent tuberkulose kendes ikke.
English: The formation of CYP450 enzymes is suppressed by increased levels of cytokines (e.g., IL-1) during chronic inflammation.
Danish: Dannelsen af CYP450-enzymer undertrykkes af de forhøjede niveauer af cytokiner (f.eks. IL-1) under kronisk inflammation.
English: Similar rates were obtained for the groups on the SOC level, except for eye disorders with 55 AEs (rate 0.5), whereof 35 ocular hyperemia (which could also be a symptom of CAPS) in the CIAS1 group, and 4 AEs in the non-CIAS1 group (rate 0.1).
Danish: Tilsvarende resultater opnåedes for grupperne på SOC-niveauet, med undtagelse af øjenlidelser med 55 bivirkninger (forekomst 0,5), hvoraf 35 var okulær hyperæmi (som også kan være et symptom på CAPS) i CIAS1-gruppen og 4 bivirkninger i non-CIAS1-gruppen (forekomst 0,1).
English: Turn the syringe so that the needle is now pointing downwards.
Danish: Drej sprøjten så kanylen nu vender nedad.
English: This treatment combination has not demonstrated increased clinical benefit.
Danish: Denne kombination har ikke vist øget kliniske fordele.
English: Patients should be screened for latent tuberculosis prior to initiating Kineret.
Danish: Patienten skal screenes for latent tuberkulose før iværksættelse af behandlingen med Kineret.
English: Child
Danish: Barn
English: Patients are usually well-controlled by maintaining the recommended starting dose (1-2 mg/kg/day).
Danish: Patienterne kan normalt kontrolleres tilfredsstillende ved at fastholde den anbefalede startdosis (1-2 mg/kg/dag).
English: • The prescribed dose of Kineret
Danish: • Den ordinerede dosis af Kineret
English: Cooling of the injection site, warming the injection liquid to room temperature, use of cold packs (before and after the injection), and use of topical glucocorticoids and antihistamines after the injection can alleviate the signs and symptoms of injection site reactions.
Danish: Afkøling af injektionsstedet, opvarmning af injektionsvæsken til stuetemperatur, brug af kolde omslag (før og efter injektion) og brug af topiske glukokortikoider og antihistaminer efter injektionen kan lindre tegn og symptomer på reaktioner på injektionsstedet.
English: A subset of these patients continued open-label treatment with Kineret for up to 1 year in a companion extension study.
Danish: En undergruppe af disse patienter fortsatte open-labelbehandlingen med Kineret i op til 1 år i en ledsagende forlængelsesundersøgelse.
English: It is unknown whether anakinra/metabolites are excreted in human milk.
Danish: Det er ukendt, om anakinra/metabolitter udskilles i human mælk.
English: Maximal clinical response was generally seen within 12 weeks after starting treatment.
Danish: Maksimal klinisk respons sås oftest i løbet af de første 12 uger efter behandlingen var påbegyndt.
English: Take your Kineret pre-filled syringe out of the refrigerator.
Danish: Tage den fyldte injektionssprøjte med Kineret ud af køleskabet.
English: Talk to your doctor before using Kineret: - if you have a history of recurring infections, or if you suffer from asthma.
Danish: Kontakt lægen, før De bruger Kineret: hvis De har oplevet tilbagevendende infektioner eller hvis De lider af astma.
English: A formal toxicologic and toxicokinetic interaction study in rats revealed no evidence that Kineret alters the toxicologic or pharmacokinetic profile of methotrexate.
Danish: Et formelt toksikologisk og toksikokinetisk interaktionsstudie hos rotter viste ikke tegn på, at Kineret forandrer methotrexats toksikologiske eller farmakokinetiske profil.
English: In clinical trials, interactions between Kineret and other medicinal products (including nonsteroidal anti-inflammatory medicinal products, glucocorticoids, and DMARDs) have not been observed.
Danish: I kliniske forsøg er interaktioner mellem Kineret og andre lægemidler (inklusiv non-steroide anti-inflammatorika, glukokortikoider og DMARD'er) ikke observeret.
English: • Information on macrophage activation syndrome (MAS) in patients receiving the product for the treatment of Still's disease
Danish: • Information om makrofag-aktiveringssyndrom (MAS) hos patienter, der får præparatet til behandling af Stills sygdom
English: In CAPS patients approximate dose linearity with a slight tendency to higher than proportional increase has been noted.
Danish: Hos CAPS-patienter har der været bemærket en tilnærmet dosislinearitet med en let tendens til en mere end proportional stigning.
English: In RA patients, no unexpected accumulation of anakinra was observed after daily subcutaneous doses for up to 24 weeks.
Danish: Hos RA-patienter blev ingen uforudset akkumulation af anakinra observeret efter daglige subkutane doser i op til 24 uger.
English: The active substance of Kineret is anakinra, this works in the same way as your natural interleukin-1 blocking protein.
Danish: Det aktive stof i Kineret er anakinra, der virker på samme måde som det naturlige blokeringsprotein interleukin-1.
English: In a standard battery of tests designed to identify hazards with respect to DNA, anakinra did not induce bacterial or mammalian cell gene mutations.
Danish: I en standard opsætning af test som er designet til at identificere risici med hensyn til DNA, inducerede anakinra hverken genmutationer hos bakterier eller pattedyr.
English: Medicines called tumour necrosis factor (TNF-α) inhibitors, such as etanercept should not be used with Kineret because this may increase the risk of infections.
Danish: Visse lægemidler, som kaldes TNF- α-hæmmere (tumornekrosefaktorhæmmere), som f.eks. etanercept, må ikke anvendes sammen med Kineret, fordi dette kan øge risikoen for infektioner.
English: - if you are allergic to anakinra or any of the other ingredients of this medicine, listed in section 6; - if you are allergic to other products that are produced by DNA technology using the micro organism E. coli; - if you have neutropenia (low white blood cell count) determined after a blood test.
Danish: - hvis De er allergisk over for anakinra eller et af de øvrige indholdsstoffer i Kineret (angivet i punkt 6); - hvis De er allergisk over for andre produkter produceret ved hjælp af DNA-teknologi, hvor mikroorganismen E. coli er anvendt; - hvis en blodprøve viser, at De har nedsat antal hvide blodlegemer (neutropeni).
English: Glucocorticoid doses can in many cases be reduced after initiation of Kineret therapy.
Danish: Glukokortikoiddoser kan i mange tilfælde reduceres, efter behandlingen med Kineret påbegyndes.
English: Both episodes of neutropenia resolved over time with continued Kineret treatment.
Danish: Begge neutropeni-episoder gik over med tiden med fortsat Kineret-behandling.
English: No dose adjustments are expected to be required.
Danish: Der forventes ikke at være behov for dosisjusteringer.
English: An adverse event profile similar to that seen in adult RA patients was observed in these studies.
Danish: En bivirkningsprofil svarende til den, der ses hos voksne RA-patienter, sås i disse undersøgelser.
English: Anakinra had no observed effect on the fertility, early development, embryo-foetal development, or peri- and postnatal development in the rat at doses up to 100 times the human dose (2 mg/kg/day).
Danish: Anakinra har ikke vist nogen effekt på fertilitet, tidlig udvikling, embryo/fosterudvikling eller perieller postnatal udvikling hos rotter i doser op til 100 gange den humane dosis (2 mg/kg/dag).
English: • If you had a dose lower than 100 mg you will have been told to eject liquid from the syringe onto a gauze or tissue.
Danish: • Hvis Deres dosis er lavere end 100 mg, har De fået besked på at tømme væske ud af sprøjten på et stykke gaze eller en serviet.
English: Your doctor may decide that it would be more convenient for you to inject Kineret yourself.
Danish: Deres læge vil afgøre, om det er lettere, hvis De selv injicerer Kineret.
English: Do not reuse a syringe as this can cause infection.
Danish: Sprøjten må ikke genbruges, idet dette kan give anledning til infektion.
English: The absolute bioavailability of anakinra after a 70 mg subcutaneous bolus injection in healthy subjects (n = 11) is 95%.
Danish: Anakinras absolutte biotilgængelighed efter 70 mg subkutan bolusinjektion hos raske forsøgspersoner (n = 11) er 95%.
English: Analysis of treatment-emergent AEs classified by presence of CIAS1 mutation showed that there were no major differences between the CIAS1 and non-CIAS1 groups in overall AE reporting rates, 7.4 and 9.2, respectively.
Danish: En analyse af behandlingsrelaterede bivirkninger klassificeret efter tilstedeværelsen af CIAS1mutation viste, at der ikke var væsentlige forskelle mellem CIAS1- og non-CIAS1-grupperne for så vidt angår den generelle forekomst af bivirkningsindberetninger, der var henholdsvis 7,4 og 9,2.
English: Routine testing of hepatic enzymes during the first month should be considered, especially if the patient has pre-disposing factors or develops symptoms indicating liver dysfunction.
Danish: Rutinemæssig kontrol af leverenzymer i løbet af den første måned bør overvejes, især hvis patienten har prædisponerende faktorer, eller udvikler symptomer, der indikerer leverdysfunktion.
English: Untreated CAPS patients are characterized by increased CRP, SAA and IL-6 relative to normal serum levels.
Danish: Ubehandlede CAPS-patienter er kendetegnet ved forhøjet CRP, SAA og IL-6 i forhold til de normale serumniveauer.
English: It is recommended that neutrophil counts be assessed prior to initiating Kineret treatment, and while receiving Kineret, monthly during the first 6 months of treatment and quarterly hereafter.
Danish: Det skal anbefales, at de neutrofile optællinger bliver foretaget inden behandling med Kineret påbegyndes, og når behandling med Kineret er i gang, månedligt de første 6 måneder og derefter kvartalsvist.
English: The absorption process is the rate-limiting factor for the disappearance of anakinra from the plasma after subcutaneous injection.
Danish: Absorptionsprocessen er den hastighedsbestemmende faktor for anakinras elimination fra plasma efter subkutan injektion.
English: For more information on neutropenia see section 4.8.
Danish: 4.8 for yderligere oplysninger om neutropeni.
English: Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with Still's disease.
Danish: Makrofag aktiveringssyndrom (MAS) er en kendt, livstruende sygdom, der kan udvikle sig hos patienter med Stills sygdom.
English: In placebo-controlled RA studies with Kineret, treatment was associated with small reductions in the mean values for total white blood count and absolute neutrophil count (ANC).
Danish: I placebokontrollerede RA-undersøgelser med Kineret var behandling forbundet med en lille reduktion af gennemsnitsværdierne for det totale antal hvide blodlegemer og det absolutte neutrofiltal (ANC).
English: Neither did anakinra increase the incidence of chromosomal abnormalities or micronuclei in bone marrow cells in mice.
Danish: Anakinra forøgede heller ikke antallet af kromosomabnormaliteter eller micronuclei i knoglemarvsceller hos mus.
English: In RA, CAPS and in Still's disease, your body produces too much of a cytokine called interleukin-1.
Danish: Ved RA, CAPS og Stills sygdom producerer kroppen for meget af det cytokin, som hedder interleukin-1.
English: In 43 CAPS patients followed for up to 5 years the frequency of serious infections was 0.1/year, the most common being pneumonia and gastroenteritis.
Danish: Hos 43 CAPS-patienter, der blev fulgt i op til 5 år, var hyppigheden af alvorlige infektioner 0,1/år, og de mest almindelige var lungebetændelse og gastroenteritis.
English: A rapid and sustained decrease in the levels of the inflammatory biomarkers; serum amyloid A (SAA), C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), and a normalization of inflammatory hematological changes are seen.
Danish: Der ses et hurtigt og vedvarende fald i koncentrationen af de inflammatoriske biomarkører serum amyloid A (SAA), C-reaktivt protein (CRP) og erytrocytsedimentationraten (ESR) og en normalisering af inflammatoriske hæmatologiske ændringer.
English: Before administration, visually inspect the solution for particulate matter and discolouration.
Danish: Før administration kontrolleres opløsningen for synlige partikler og misfarvning.
English: It is important that you do not try to give yourself or your child the injection unless you have received training from a doctor, nurse or pharmacist.
Danish: Det er vigtigt, at De ikke forsøger at give Dem selv eller Deres barn injektionen, før Deres læge, sygeplejerske eller apotekspersonalet har vist Dem hvorledes.
English: With careful monitoring, Kineret treatment can be continued also during a serious infection.
Danish: Med nøje overvågning kan behandlingen med Kineret fortsættes, selv under en alvorlig infektion.
English: Do not inject more Kineret.
Danish: De må ikke tage mere Kineret.
English: Kineret must be injected under your skin (subcutaneous) daily.
Danish: Kineret skal indgives under huden (subkutan injektion) dagligt.
English: Symptoms of infection might include a fever or a sore throat.
Danish: Symptomer på infektion kan inkludere feber eller ondt i halsen.
English: Patients with Still's disease have an increased risk of spontaneous development of MAS.
Danish: Patienter med Stills sygdom har en øget risiko for at udvikle MAS spontant.
English: Kineret can be given as monotherapy or in combination with other anti-inflammatory drugs and disease-modifying antirheumatic drugs (DMARDs).
Danish: Kineret kan gives som monoterapi eller i kombination med andre anti-inflammatorika og sygdomsmodificerende antireumatiske lægemidler (disease-modifying antirheumatic drugs, DMARD'er).
English: A clinical response to anakinra generally appeared within 2 weeks of initiation of treatment and was sustained with continued administration of anakinra.
Danish: Klinisk respons på anakinra sås som regel i løbet af 2 uger efter behandlingen var påbegyndt, og var vedvarende ved fortsat behandling med anakinra.
English: The role of IL-1 in the pathogenesis of Still's disease has been demonstrated by ex vivo and gene expression studies.
Danish: IL-1's rolle i patogenesen af Stills sygdom er blevet vist i ex vivo- og genekspressionsstudier.
English: • That it is not recommended to start treatment with Kineret in patients with an ongoing infection
Danish: • At det ikke anbefales at starte behandlingen med Kineret hos patienter med en aktuel infektion
English: The safety and efficacy of anakinra in combination with methotrexate have been demonstrated in 1,790 RA patients ≥ 18 years of age with varying degrees of disease severity.
Danish: Anakinras sikkerhed og virkning i kombination med methotrexat er blevet påvist hos 1.790 RApatienter ≥18 år med forskellig sværhedsgrad af sygdom.
English: Pharmacokinetic data in children < 4 years are lacking, but clinical experience is available from 8 months of age, and when started at the recommended daily dose of 1-2 mg/kg, no safety concerns have been identified.
Danish: Der mangler farmakokinetiske data for børn <4 år, men der er kliniske erfaring fra en alder af 8 måneder, og der er ikke blevet identificeret nogen sikkerhedsproblemer ved behandlingsstart med den anbefalede daglige dosis på 1-2 mg/kg.
English: Infections have been noted in all organ systems and have been reported in patients receiving Kineret alone or in combination with immunosuppressive agents.
Danish: Infektioner er blevet observeret i alle organsystemer og er blevet rapporteret hos patienter, som udelukkende behandles med Kineret, eller som får kombinationsbehandling med immunsuppressiva.
English: The activated inflammasome results in proteolytic maturation and secretion of IL-1β, which has a broad range of effects including systemic inflammation.
Danish: Det aktiverede inflammasom resulterer i proteolytisk modning og udskillelse af IL-1β, som har en bred vifte af virkninger herunder systemisk inflammation.
English: 17 patients completed the open-label extension phase (Week 52), of which 7 of 14 Kineret-treated patients, and 2 of 3 patients on DMARDs, were in remission at that time point.
Danish: 17 patienter gennemførte open-label forlængelsesfasen (uge 52), hvoraf 7 ud af 14 patienter i behandling med Kineret, og 2 ud af 3 patienter i behandling med DMARD'er var i remission på dette tidspunkt.
English: Any unused medicine must be discarded.
Danish: Ikke anvendt lægemiddel skal bortskaffes.
English: Do not use it if the date has passed the last day of the month shown.
Danish: Anvend ikke den fyldte injektionssprøjte, hvis den sidste dato i den angivne måned er passeret.