FrancophonIA/ELRC3.0 huggingface dataset:
English: Part A of the trial was initiated in the winter months, while Part B was predominantly performed in the summer months.
Danish: Del A af undersøgelsen blev indledt i vintermånederne, mens Del B hovedsageligt blev udført i sommermånederne.
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Danish: I overensstemmelse med paragraf 114 i direktiv 2001/83/EF foretages den officielle batchfrigivelse af et statsligt laboratorium eller et laboratorium, der er udpeget til formålet.
English: The patients should be included in the Registry until both following conditions are met: 5 years recruitment period and 200 patients included.
Danish: Patienterne bør inkluderes i registret, indtil følgende 2 betingelser er opfyldt: 5-års rekrutteringsperiode og 200 patienter inkluderet.
English: This medicinal product has been authorised under “Exceptional Circumstances”.
Danish: Dette lægemiddel er godkendt under “særlige omstændigheder”.
English: Figure 13a (Adults)
Danish: Figur 13a (voksne)
English: This medicine has been given ‘conditional approval'.
Danish: Denne medicin har fået en ”betinget godkendelse”.
English: Do not inject a double dose to make up for the forgotten dose.
Danish: De må ikke injicere en dobbeltdosis som erstatning for den glemte dosis.
English: Do not touch this area again before injecting.
Danish: Rør ikke ved dette område igen før injicering.
English: • The possibility to include patients in the registry study to facilitate the collection of long term efficacy and safety data;
Danish: • Muligheden for at inkludere patienterne i registerstudiet, for at facilitere indsamlingen af data for virkning og sikkerhed på langt sigt;
English: You should tell your doctor if you have:
Danish: De bør fortælle det til Deres læge, hvis De har:
English: Vial 2 years.
Danish: Hætteglas 2 år.
English: Contents of the pack and other information
Danish: Indholdet i pakningen og andre oplysninger
English: Reduction from Baseline
Danish: Reduktion fra baseline
English: Your doctor may need to perform some tests and adjust the dose of such medicines.
Danish: Det kan være nødvendigt, at Deres læge udfører nogle tests og justerer dosen af denne type medicin.
English: This means that there is more evidence to come about this medicine.
Danish: Det betyder, at der kommer yderligere dokumentation vedrørende denne medicin.
English: None of these patients had serious infections associated with the neutropenia.
Danish: Ingen af disse patienter havde svære infektioner forbundet med neutropeni.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 to 8°C.
Danish: Hvis det ikke anvendes med det samme, er opbevaringstiderne under anvendelse og forhold før anvendelse brugerens ansvar, og bør ikke være længere end 24 timer ved 2 til 8°C.
English: • if you have an active, severe infection.
Danish: • hvis De har en aktiv, svær infektion.
English: Repeat step 7 until the powder is completely dissolved and the solution is clear.
Danish: Trin 7 gentages indtil pulveret er fuldstændigt opløst, og opløsningen er klar.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Danish: Dette er en tilladelse under særlige omstændigheder og ifølge paragraf 14(8) i EU-forordning nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme udføre følgende foranstaltninger:
English: Figure 13b (Small Children, Thin Patients)
Danish: Figur 13b (små børn, tynde patienter)
English: Proceed with the injection as described in Step 6 below.
Danish: Fortsæt med indsprøjtningen, som beskrevet i Trin 6 herunder.
English: In both cases your doctor will calculate the corresponding volume to inject.
Danish: I begge tilfælde vil Deres læge beregne det tilhørende injektionsvolumen.
English: In the clinical program for CAPS, 8 adolescents aged 12-17 were treated for up to 18 months.
Danish: I det kliniske program for CAPS, blev 8 unge i alderen 12-17 år behandlet i op til 18 måneder.
English: Women who are pregnant or who desire to become pregnant should therefore only be treated after a thorough benefit-risk evaluation.
Danish: Kvinder, som er gravide eller ønsker at blive gravide, bør derfor kun behandles efter er grundig evaluering af risk/benefit-forholdet.
English: This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
Danish: Denne indlægsseddel findes på alle EU/EØF-sprog på Det Europæiske Lægemiddelagenturs hjemmeside.
English: • The identified or potential risk of immunogenicity that might lead to immune-mediated symptoms;
Danish: • Den identificerede og potentielle risiko for immunogenicitet, der kan føre til immunmedierede symptomer;
English: Animal studies were conducted to assess reproductive toxicity.
Danish: Undersøgelser i dyr blev udført for at vurdere reproduktionstoksicitet.
English: When the container is about twothirds full, dispose of it as instructed by your doctor or pharmacist.
Danish: Når beholderen er omkring totredjedel fuld, skal den bortskaffes som anvist af Deres læge eller apoteket.
English: If you feel a spinning sensation, do not drive or operate any tools or machines until you are feeling normal again.
Danish: Hvis De oplever en snurrende fornemmelse, bør De ikke køre eller betjene værktøj eller maskiner, indtil De igen føler Dem normalt tilpas.
English: • The role and use of patient alert card.
Danish: • Rollen og anvendelsen af alarmeringskortet til patienter.
English: The maximum amount of product that can be safely administered has not been determined.
Danish: Den maksimale dosis lægemiddel, som det er sikkert at administrere, er ikke blevet bestemt.
English: Your doctor will tell you how much medicine to inject.
Danish: Lægen vil fortælle Dem, hvor meget medicin, der skal injiceres.
English: The expiry date refers to the last day of that month.
Danish: Udløbsdatoen henviser til sidste dag i den nævnte måned.
English: • The proper patient management as regards the interaction with vaccination;
Danish: • Korrekt håndtering af patienter angående interaktion ved vaccinationen;
English: • The need for Health Care Professionals to perform an annual clinical assessment of patients regarding a potential increased risk for the development of malignancies;
Danish: • Nødvendigheden af, at sundhedspersonalet udfører en årlig klinisk vurdering af patienterne, med hensyn til en mulig forhøjet risiko for udvikling af maligniteter;
English: Mutation in NLRP3 gene
Danish: Mutation in NLRP3-genet
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Danish: Hvis De er gravid, tror De kan være gravid, eller hvis De planlægger at blive gravid, skal De rådføre Dem med Deres læge, før De tager denne medicin.
English: Active Rilonacept Baseline Period (Weeks 13 to 15)
Danish: Aktiv rilonacept baseline-periode (Uge 13 til 15)
English: It is not intended for intravenous or intramuscular use.
Danish: Det er ikke beregnet til intravenøs eller intramuskulær anvendelse.
English: During the open-label extension, reductions in mean symptom scores, serum CRP, and serum SAA levels were maintained for up to one year.
Danish: Under open-label forlængelsesfasen, blev reduktionerne i gennemsnitlige symptomscoringer, serum CRP- og serum SAA-niveauerne opretholdt i op til et år.
English: With PSUR
Danish: Med PSUR
English: Put the following items on a clean flat surface (see Figure 1):
Danish: Sæt de følgende dele på en ren, plan overflade (se Figur 1):
English: Not applicable.
Danish: Ikke gældende.
English: Do not use the solution if it is discoloured or cloudy, or if it contains small particles (see Figure 8).
Danish: Opløsningen må ikke anvendes, hvis den er misfarvet eller uklar, eller hvis den indeholder små partikler (se Figur 8).
English: Adults who entered in Part A
Danish: Voksne, som indgik i Del A
English: Treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of CAPS.
Danish: Behandlingen bør påbegyndes og superviseres af en speciallæge med erfaring i diagnosticering og behandling af CAPS.
English: Reported ISRs were generally mild to moderate in severity.
Danish: De indberettede ISR'er var generelt af en mild til moderat sværhedsgrad.
English: Regeneron UK Limited 40 Bank Street E14 5DS London United Kingdom
Danish: Regeneron UK Limited 40 Bank Street E14 5DS London Storbritannien
English: The changes in mean symptom scores for the randomised parallel-group period (Part A) and the randomised withdrawal period (Part B) of the study are shown in Table 3.
Danish: Ændringerne i de gennemsnitlige symptomscoringer for den randomiserede parallel-gruppe-periode (Del A) og den randomiserede tilbagetrækningsperiode (Del B) af undersøgelsen er vist i Tabel 3.
English: Decreases in β-estradiol levels were seen in the treated groups, the significance of this finding is unknown.
Danish: Reduktioner i niveauerne af β-østradiol blev set i de behandlede grupper, men betydningen af dette resultat er ikke kendt.
English: Read these instructions all the way through before beginning.
Danish: Læs hele denne vejledning grundigt før start.
English: Age (26-78 years old) and body weight (50-120 kg) did not appear to have a significant effect on trough rilonacept concentrations.
Danish: Alder (26-78 år) og kropsvægt (50-120 kg) havde ikke en signifikant effekt på dalværdierne af rilonacept.
English: If the powder has not completely dissolved, shake the vial quickly back and forth for 30 seconds more.
Danish: Hvis pulveret ikke er fuldstændigt opløst, rystes hætteglasset hurtigt frem og tilbage i endnu 30 sekunder.
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil gennemgå nye oplysninger om denne medicin mindst hvert år, og denne indlægsseddel vil blive opdateret efter behov.
English: The fact that a limited number of paediatric patients were included in the clinical studies combined with the lack of data on the effect of long term IL-1ß suppression is a concern in view of the orphan nature of the condition.
Danish: Det faktum, at et begrænset antal pædiatriske patienter blev inkluderet i de kliniske studier, sammen med mangel på data over effekten af langvarig undertrykkelse af IL-1ß, er en bekymring, givet tilstandens 'orphanagtige natur'.
English: Contains:
Danish: Indeholder:
English: The results for the adults who entered the study in Part A are provided separately from the results of the adults who entered directly into the open label extension; the results for the four adolescents who entered directly into the open label extension are provided individually.
Danish: Resultaterne for de voksne, som indgik i undersøgelsens Del A, angives separat fra resultaterne for de voksne, som indgik direkte i open-label forlængelsen; resultaterne for de fire unge, som indgik direkte i open-label forlængelsen, gives enkeltvis.
English: The experience in children is limited.
Danish: Erfaring med behandling af børn er begrænset.
English: However, clinical experience in such patients is limited.
Danish: Klinisk erfaring hos sådanne patienter er dog begrænset.
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret denne medicin udelukkende til Dem.
English: The following information is intended for medical or healthcare professionals only and is provided as a tear-off leaflet:
Danish: Følgende oplysninger er kun tiltænkt læger og sundhedspersonale og leveres som en indlægsseddel, der kan rives af:
English: Begin at the centre of the site and move outward.
Danish: Begynd midt på stedet og bevæge udad.
English: The risk for the foetus/mother is unknown.
Danish: Risikoen for fosteret/moderen kendes ikke.
English: Where to inject Inject in a different place each time in order to keep your skin healthy.
Danish: Injektionssted De bør foretage indsprøjtningerne på et nyt sted hver gang for at holde Deres hud sund.
English: After the addition of solvent, the vial contents should be reconstituted by shaking the vial for approximately one minute and then allowing it to sit for one minute.
Danish: Efter tilsætning af solvensen, skal indholdet i hætteglasset rekonstitueres ved at ryste hætteglasset i ca. et minut, og derefter lade det stå i et minut.
English: As with other large proteins elimination of rilonacept is expected to be via proteolytic catabolism and target mediated clearance.
Danish: Som for andre store proteiner, forventes elimineringen af rilonacept at ske gennem proteolytisk katabolisme og målrettet clearance.
English: Hold the syringe in one hand like you would hold a pencil.
Danish: Hold sprøjten i den ene hånd, som De ville holde på en blyant.
English: Available data indicate that dose modification is not required based on advanced age.
Danish: De foreliggende data indikerer, at dosisjustering på grund af fremskreden alder ikke er nødvendig.
English: This is clinically relevant for CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin).
Danish: Dette er klinisk relevant for CYP450-substrater med et snævert terapeutisk indeks, hvor dosis justeres individuelt (f.eks. warfarin).
English: Further PK steady state exposure data (AUC, Cmax, Cmin during steady state) especially for paediatric subjects is required.
Danish: Yderligere farmakokinetiske steady state eksponeringsdata er påkrævet (AUC, Cmax, Cmin under steady state), specielt for pædiatriske forsøgspersoner.
English: If a patient becomes neutropenic the ANC should be monitored closely and treatment discontinuation should be considered.
Danish: Hvis en patient bliver neutropen, bør ANC nøje monitoreres, og det bør overvejes at afbryde behandlingen.
English: Week 24 Mean KSS
Danish: Uge 24 Gennemsnitlig KSS
English: • Other medicines that block interleukin-1, such as anakinra or canakinumab.
Danish: • Anden medicin, der blokerer interleukin-1, som anakinra eller canakinumab.
English: HR3 5PG Hereford United Kingdom
Danish: HR3 5PG Hereford Storbritannien
English: Cholesterol and lipid levels may be reduced in patients with chronic inflammation.
Danish: Kolesterol- og lipidniveauer kan være reduceret hos patienter med kronisk inflammation.
English: • Inflammation of the eye (iritis)
Danish: • Betændelse i øjet (iritis)
English: The efficacy portion of the study included 47 patients, 44 of whom had a diagnosis of FCAS and 3 with a diagnosis of MWS.
Danish: Den del af undersøgelsen, som undersøgte virkning, inkluderede 47 patienter, hvoraf 44 havde en diagnose på FCAS og 3 havde en diagnose på MWS.
English: Paediatric population (up to 12 years old)
Danish: Pædiatrisk population (op til 12 år)
English: • The risk of acute injection-related reactions;
Danish: • Risikoen for akutte injektionsrelaterede reaktioner;
English: Ask your doctor, nurse or pharmacist for advice before taking any medicine.
Danish: Spørg Deres læge, sygeplejerske eller apoteket til råds, før De tager nogen form for medicin.
English: Endpoint Period (Weeks 22 to 24)
Danish: Endepunktsperioden (Uge 22 til 24)
English: Changes in lipid parameters
Danish: Ændringer i lipidparametre
English: Each vial should be used for a single dose only.
Danish: Hvert hætteglas må kun anvendes til en enkelt dosis.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated-dose toxicity.
Danish: De prækliniske data indikerer ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi og toksicitet efter gentagne doser.
English: • The need to monitor patients for changes in their lipid profiles;
Danish: • Behovet for at overvåge ændringer i patienternes lipidprofiler;
English: Physicians should monitor the lipid profiles of their patients (for example after 2-3 months) and consider lipid-lowering therapies as needed based upon cardiovascular risk factors and current guidelines.
Danish: Lægerne bør overvåge patienternes lipidprofiler (for eksempel efter 2-3 måneder) og overveje de nødvendige lipidsænkende behandlinger, baseret på kardiovaskulære risikofaktorer og aktuelle retningslinjer.
English: Let the vial sit for about 1 minute.
Danish: Lad hætteglasset hvile i omkring 1 minut.
English: Rilonacept also led to a significant decrease in serum amyloid A (SAA) versus baseline to levels within the normal range.
Danish: Rilonacept førte også til en signifikant reduktion i serum amyloid A (SAA) versus baseline, til niveauer inden for normalområdet.
English: Elderly (65 years old or older)
Danish: Ældre (65 år og derover)
English: The physician information should contain the following key messages:
Danish: Informationen til læger bør indeholde essentielle oplysninger om følgende:
English: No study was conducted to evaluate the effect of age, gender, or body weight on rilonacept exposure.
Danish: Ingen undersøgelser er blevet udført for at undersøge effekten af alder, køn eller kropsvægt på eksponering med rilonacept.
English: Bioavailability of rilonacept after a subcutaneous injection is estimated to be approximately 50%.
Danish: Rilonacepts biotilgængelighed efter en subkutan injektion er estimeret til at være ca. 50 %.
English: Changes in your blood cholesterol levels or in your blood counts may also occur.
Danish: Der kan også forekomme ændringer i blodets kolesterolniveau eller Deres blodtal.
English: • The unknown safety of Rilonacept Regeneron in pregnant and lactating women, thus the need for physicians to discuss this risk with patients if they become or plan to become pregnant;
Danish: • Den ukendte sikkerhed af Rilonacept Regeneron hos gravide og ammende kvinder, som dermed medfører, at lægerne skal diskutere denne risiko med patienterne, hvis de bliver gravide eller hvis de planlægger at blive gravide;
English: Do not touch the needle with your hands or allow it to come into contact with any surfaces.
Danish: Kanylen må ikke berøres med hænderne, og den må ikke få kontakt med nogen overflader.
English: Diagnosis
Danish: Diagnose
English: This includes any possible side effects not listed in this leaflet.
Danish: Det gælder også eventuelle bivirkninger, som ikke er nævnt her.
English: Due to the small patient population, an ADR reported in 2 or more patients is classified as “common.”
Danish: På grund af den lille patientpopulation, klassificeres en bivirkning, som indberettes hos 2 eller flere patienter som “almindelig”.
English: No patients withdrew from the study due to ISRs.
Danish: Ingen patienter trak sig ud af undersøgelsen pga. ISR'er.
English: Based on limited data obtained from the clinical study, steady-state trough concentrations were similar between male and female patients.
Danish: Baseret på begrænsede data fra den kliniske undersøgelse var dalværdierne af steady state-koncentrationerne sammenlignelige mellem mandlige og kvindelige patienter.
English: You or your caregiver will receive adequate training on how to mix the powder (dissolve to make a solution), prepare the dose, and administer the injection.
Danish: De eller Deres plejer vil modtage tilstrækkelig træning i at blande pulveret (opløse det for at lave en opløsning), klargøre dosen, og administrere injektionen.
English: Talk with your doctor before making any dose adjustments.
Danish: Tal med Deres læge, før der foretages justeringer af dosis.
English: • Areas where you may inject Rilonacept Regeneron include the left and right sides of the abdomen, and left and right thighs.
Danish: • Områderne, hvor De kan injicere Rilonacept Regeneron, omfatter venstre og højre side af maven, og venstre og højre lår.
English: *p< 0.0001, comparison of rilonacept vs. placebo **p< 0.001, comparison of rilonacept vs. placebo, NS = not significant
Danish: *p< 0,0001, sammenligning af rilonacept versus placebo **p< 0,001, sammenligning af rilonacept versus placebo, NS = ikke signifikant
English: If someone else is giving you the injection, the upper arms may also be used for injection (see Figure 12): (Do not inject within a 5-cm area around the navel.)
Danish: Hvis andre giver Dem injektionen, kan overarmene også anvendes til injektion (se Figur 12): (Må ikke injiceres i et område på 5 cm rundt om navlen)
English: Pre-treatment Baseline Period (Weeks -3 to 0)
Danish: Baselineperioden før behandling (Uge -3 til 0)
English: Adults who entered in OLE
Danish: Voksne, som indgik i OLE
English: The MAH is requested to provide regular safety and efficacy data from the Global Registry for both adults and children.
Danish: Indehaveren af markedsføringstilladelsen bedes om at levere regelmæssige data for sikkerhed og virkning fra det globale register, både for voksne og børn.
English: In patients with CAPS, the body produces excessive amounts of IL-1 beta.
Danish: Hos patienter med CAPS producerer kroppen et overskud af IL-1 beta.
English: Of the 19 patients, 7 tested positive at the last assessment (Week 18 or 24 of the open-label extension period), and 5 patients tested positive for neutralising antibodies on at least one occasion.
Danish: Ud af de 19 patienter testede 7 positive ved den sidste vurdering (Uge 18 eller 24 i open-label forlængelsesperioden), og 5 patienter testede positive for neutraliserende antistoffer mindst én gang.
English: Used alcohol wipes can be thrown away in the household rubbish.
Danish: Brugte vådservietter med alkohol kan smides i skraldespanden.
English: Intravenous administration of Rilonacept Regeneron at doses of up to 2000 mg monthly in another patient population for up to six months was generally well-tolerated.
Danish: Intravenøs administration af Rilonacept Regeneron i doser på op til 2000 mg om måneden i op til seks måneder hos en anden patientpopulation var generelt veltolereret.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 October 2009
Danish: Dato for første markedsføringstilladelse: 23. oktober 2009 Dato for seneste fornyelse:
English: • Tiredness (fatigue)
Danish: • Træthed (fatigue)
English: Using a daily diary questionnaire, patients rated the following five signs and symptoms of CAPS: joint pain, rash, feeling of fever/chills, eye redness/pain, and fatigue, each on a scale of 0 (none, no severity) to 10 (very severe).
Danish: Ved hjælp af et spørgeskema i dagbogsform, bedømte patienterne følgende fem tegn og symptomer på CAPS: ledsmerter, udslæt, feberfølelse/kuldegysninger, røde øjne/øjensmerter og træthed, hver på en skala fra 0 (ingen, ingen sværhedsgrad) til 10 (meget svære).
English: The formation of CYP450 enzymes is suppressed by increased levels of cytokines during chronic inflammation.
Danish: Dannelsen af CYP450-enzymer undertrykkes af forhøjede niveauer af cytokiner under kronisk inflammation.
English: A study of embryo-foetal development was conducted with rilonacept in monkeys at doses up to approximately 4 times the human dose.
Danish: En undersøgelse af embryoføtal udvikling i aber blev udført med rilonacept i doser på op til ca. 4 gange den humane dosis.
English: Paediatric population (12 to 17 years old)
Danish: Pædiatrisk population (12 til 17 år)
English: 1 Based on population PK modelling 2 Derived values are presented.
Danish: Baseret på populationsmodellering af farmakokinetik 2 Afledte værdier angivet.
English: • The need to instruct patients on proper techniques for self-administration when the patient is willing and capable to do so, and guidance for Health Care Professionals on how to report administration errors;
Danish: • Behovet for at instruere patienter i den korrekte teknik til selvadministration, når patienten indvilliger i og er i stand til at gøre dette, og vejledning af sundhedspersonale i indberetning af administrationsfejl;
English: Endpoint Period (Weeks 4 to 6)
Danish: Endepunktsperioden (Uge 4 til 6)