FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that white blood cell (WBC) counts including neutrophil counts be assessed prior to initiating treatment and again after 1 to 2 months.
Danish: Det anbefales, at antal hvide blodlegemer (WBC) inklusive neutrofiltal vurderes før initiering af behandling og igen efter 1 til 2 måneder.
English: The median improvement from baseline to end of Part I of study G2301 was 0.88 (79%).
Danish: Den mediane forbedring fra baseline til slutning af del I af studie G2301 var 0,88 (79 %).
English: More information on each of these diseases is given below.
Danish: Du kan se mere information om de enkelte sygdomme nedenfor.
English: Table 4 Paediatric ACR response and disease status at days 15 and 29
Danish: Tabel 4 Pædiatrisk ACR-respons og sygdomsstatus på dag 15 og 29
English: Results for the components of the adapted paediatric ACR which included systemic and arthritic components, were consistent with the overall ACR response results.
Danish: Resultater for de komponenter af den tilpassede pædiatriske ACR, som inkluderer systemiske og artikulære komponenter, stemte overens med de overordnede ACR-respons-resultater.
English: Treatment difference for all ACR scores was significant (p ≤ 0.0001)
Danish: Behandlingsforskel for alle ACR-scorer var signifikant (p ≤ 0,0001)
English: The primary objective was the proportion of patients at day 15 who achieved a minimum 30% improvement in the paediatric American College of Rheumatology (ACR) response criterion adapted to include absence of fever.
Danish: Det primære mål var antallet af patienter på dag 15, der havde opnået mindst 30 % forbedring i det pædiatriske American College of Rheumatology (ACR) responskriterium tilpasset til at inkludere fravær af feber.
English: if you need to have any vaccinations.
Danish: hvis du skal vaccineres.
English: Secondary endpoints (disease and inflammatory markers)
Danish: Sekundære endepunkter (sygdomsrelaterede og inflammatoriske markører)
English: The majority of these events were mild in severity.
Danish: Størstedelen af disse tilfælde var lette.
English: Fewer patients aged 2 to < 4 years achieved complete response (57.1%) than older paediatric and adult patients.
Danish: Færre patienter i alderen 2 til <4 år opnåede fuldt respons (57,1 %) sammenlignet med ældre pædiatriske og voksne patienter.
English: Women who are pregnant or who desire to become pregnant should therefore only be treated after a thorough benefit-risk evaluation.
Danish: Kvinder, der er gravide eller ønsker at blive gravide, bør derfor kun behandles efter grundig vurdering af fordele/risici.
English: If the solution has a distinctly brown discolouration it should not be used.
Danish: Hvis opløsningen har en tydelig brun misfarvning må den ikke anvendes.
English: Time to flare:
Danish: Tid til udbrud:
English: Adverse reactions are listed according to MedDRA system organ class.
Danish: Bivirkninger er listet i henhold til MedDRA-organklassesystem.
English: Frequency categories are defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
Danish: Hyppigheden er defineret i henhold til følgende konvention: meget almindelig (1/10); almindelig (1/100 til <1/10); ikke almindelig (1/1.000 til <1/100), sjælden (1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: In the event of conversion from a negative to a positive PPD test, especially in high-risk patients, alternative means of screening for a tuberculosis infection should be considered.
Danish: I tilfælde af konversion fra negativ til positiv tuberkulintest bør man, især hos højrisikopatienter, overveje alternative metoder til screening for tuberkuloseinfektion.
English: * Denotes significant p-value ≤ 0.025
Danish: * Betegner signifikant p-værdi ≤ 0,025
English: The efficacy observed in the studies G2305 and G2301 was maintained in the ongoing, open-label long-term extension study (data available through median of 49 weeks of follow-up).
Danish: Den observerede effekt i studierne G2305 og G2301 var opretholdt i det igangværende, open-label langtidsforlængelsesstudie (data tilgængelige for gennemsnitligt 49 ugers opfølgning).
English: The clinical impact of this is unknown.
Danish: Den kliniske effekt af dette er ukendt.
English: Mild (< LLN and > 75 x 10
Danish: Let (<LLN og >75 x 10
English: 9/l were reported in 2% of patients in the comparative trials.
Danish: 9/l blev indberettet hos 2 % af patienterne i sammenligningsstudierne.
English: This product information has been updated to include the results of studies with Ilaris in the paediatric population.
Danish: Denne produktinformation er blevet ajourført til at omfatte resultaterne fra studier med Ilaris hos den pædiatriske population.
English: The study included 243 CAPS patients (including 85 patients less than 18 years of age).
Danish: Studiet inkluderede 243 CAPS patienter (inklusive 85 patienter under 18 år).
English: Ilaris has minor influence on the ability to drive and use machines.
Danish: Ilaris påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Danish: KARTON FOR DELPAKNING AF MULTIPAKNING (UDEN BLUE BOX)
English: The risk for the foetus/mother is unknown.
Danish: Risikoen for fostret/moderen kendes ikke.
English: No gender or age-related pharmacokinetic differences were observed after correction for body weight.
Danish: Der blev ikke observeret nogen kønseller aldersrelaterede farmakokinetiske forskelle efter korrektion for legemsvægt.
English: Patients who experience such symptoms during Ilaris treatment should wait for this to resolve completely before driving or operating machines.
Danish: Patienter, der oplever disse symptomer under behandling med Ilaris, bør vente til de er fuldstændig forsvundet, før de fører motorkøretøj eller betjener maskiner.
English: Wash your hands with soap and water, then dry them on a clean towel.
Danish: Vask hænderne med vand og sæbe, og tør dem med et rent håndklæde.
English: Other side effects of Ilaris include: Very common (may affect more than 1 in 10 people): Infections of any kind.
Danish: Andre bivirkninger for Ilaris omfatter: Meget almindelige (kan forekomme hos flere end 1 ud af 10 patienter): Enhver form for infektion.
English: For chronic or repeated therapies, it is also recommended to assess WBC counts periodically during treatment.
Danish: Ved kronisk eller gentagen behandling anbefales det at vurdere WBC periodisk under behandlingen.
English: Inactive disease
Danish: Inaktiv sygdom
English: Mutation in NLRP3 gene in CAPS patients
Danish: Mutation i NLRP3-genet hos CAPS-patienter
English: A live vaccine should normally be given 3 months after your last injection of Ilaris and 3 months before the next one.
Danish: Levende vacciner bør normalt gives 3 måneder efter din sidste injektion med Ilaris og 3 måneder før den næste.
English: Feeling weak or very tired (fatigue, asthenia).
Danish: Føle sig afkræftet eller meget træt (energiløshed, kraftesløshed).
English: No neutralising antibodies were detected.
Danish: Ingen neutraliserende antistoffer blev målt.
English: Isolated cases of ANC counts < 0.5 x 10
Danish: Isolerede tilfælde af ANC <0,5 x 10
English: Always use new, unopened needles and syringes.
Danish: Brug altid nye, uåbnede kanyler og sprøjter.
English: All patients who received non-live, standard of care childhood vaccinations (N=7) developed protective antibody levels.
Danish: Alle patienter, der fik ikke-levende, standard børnevacciner (N=7), udviklede beskyttende antistofniveauer.
English: On initiation of canakinumab in patients being treated with this type of medicinal product, therapeutic monitoring of the effect or of the active substance concentration should be performed and the individual dose of the medicinal product adjusted as necessary.
Danish: Ved initiering af canakinumab-behandling hos patienter, der er i behandling med denne type medicin, bør terapeutisk monitorering af effekten eller af koncentrationen af den aktive substans foretages, og den individuelle dosis af lægemidlet bør justeres som nødvendigt.
English: An increased dose was administered more frequently to patients aged 2 to < 4 years and to patients with NOMID/CINCA symptoms compared with FCAS or MWS.
Danish: En øget dosis blev administreret oftere til patienter i alderen 2 til < 4 år og til patienter med NOMID/CINCA-symptomer sammenlignet med FCAS eller MWS.
English: Health-related and quality of life outcomes in studies G2305 and G2301
Danish: Resultater med hensyn til helbred og livskvalitet i studierne G2305 og G2301
English: - It is important not to try to inject yourself until you have been trained by your healthcare professional.
Danish: Det er vigtigt, at du ikke prøver at give dig selv en indsprøjtning, før du har fået grundig undervisning af sundhedspersonalet.
English: Swirl the vial slowly at an angle of about 45° for approximately 1 minute and allow to stand for about 5 minutes.
Danish: Sving hætteglasset langsomt rundt i en vinkel på omkring 45° i ca. 1 minut og lad det stå i ca. 5 minutter.
English: This is consistent with the observed increase in CL/F with body weight.
Danish: Dette er i overensstemmelse med den observerede stigning i CL/F ved højere legemsvægt.
English: This is consistent with the observations of higher exposure in higher body weight groups in CAPS patients.
Danish: Dette er i overensstemmelse med observationerne af højere eksponering i grupper med CAPS-patienter med højere kropsvægt.
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe/use Ilaris are provided with a physician information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal inden lanceringen sikre, at alle læger, som forventes at ordinere/anvende Ilaris, er forsynet med en lægeinformationspakke indeholdende følgende:
English: Only patients with confirmed NLRP3 mutation were included in the pivotal study.
Danish: Kun patienter med bekræftet NLRP3-mutation blev inkluderet i det pivotale studie.
English: Within each system organ class, the adverse reactions are ranked by frequency category with the most common first.
Danish: Inden for hver organklassesystem er bivirkningerne ordnet efter hyppighed med den hyppigste først.
English: Patients > 28 days but < 2 years of age were allowed to enter the study directly into an open-arm of Part II as nonrandomised patients (and were excluded from the primary efficacy analysis).
Danish: I studiet var det tilladt, at patienter >28 dage, men <2 år indtrådte direkte i den åbne arm af del II, som ikkerandomiserede patienter (og de blev ikke medtaget i den primære effektanalyse).
English: No change in pharmacokinetic parameters based on clearance or volume of distribution were observed between elderly patients and adult patients < 65 years of age.
Danish: Der blev ikke observeret nogen ændringer i farmakokinetiske parametre baseret på clearance og fordelingsvolumen mellem ældre patienter og voksne patienter <65 år.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørger din læge eller apotekspersonalet til råds, før du tager dette lægemiddel.
English: Interactions between canakinumab and other medicinal products have not been investigated in formal studies.
Danish: Interaktioner mellem canakinumab og andre lægemidler er ikke undersøgt i formelle studier.
English: These symptoms could be due to a serious infection, an unusual infection (opportunistic infection) or be related to low levels of white blood cells (called leukopenia or neutropenia).
Danish: Disse symptomer kan skyldes en alvorlig infektion, en usædvanlig infektion (opportunistisk infektion) eller kan skyldes et lavt antal hvide blodlegemer (kaldet leukopeni eller neutropeni).
English: Over 85% of patients had comorbidity, including hypertension (60%), diabetes (15%), ischaemic heart disease (12%), and stage ≥ 3 chronic kidney disease (25%).
Danish: Over 85 % af patienterne havde komorbiditet inklusive hypertension (60 %), diabetes (15 %), iskæmisk hjertesygdom (12 %) og kronisk nyresygdom stadie ≥3 (25 %).
English: If possible, avoid touching the rubber stopper with your fingers.
Danish: Undgå så vidt muligt at berøre gummiproppen med fingrene.
English: The terminal half-life ranged from 22.9 to 25.7 days, similar to the pharmacokinetic properties observed in adults.
Danish: Den terminale halveringstid lå i intervallet 22,9 til 25,7 dage, svarende til de farmakokinetiske egenskaber, der sås hos voksne.
English: Neutropenia and leukopenia
Danish: Neutropeni og leukopeni
English: Inflammatory markers* C-reactive protein, mg/l Serum amyloid A, mg/l * mean (median) change from beginning of Part II
Danish: Inflammatoriske markører* C-reaktivt protein, mg/l Serumamyloid A, mg/l * gennemsnitlig (medianværdi) ændring fra begyndelsen af del II
English: Ilaris is indicated for the treatment of Familial Mediterranean Fever (FMF).
Danish: Ilaris er indiceret til behandling af familiær middelhavsfeber (FMF).
English: If you accidentally inject more Ilaris than the recommended dose, it is unlikely to be serious, but you should inform your doctor, pharmacist or nurse as soon as possible.
Danish: Hvis du kommer til at indsprøjte mere Ilaris end den anbefalede dosis, er det sandsynligvis ikke alvorligt, men du bør hurtigst muligt fortælle det til lægen, på apoteket eller til sundhedspersonalet.
English: They should not be used with Ilaris because this may increase the risk of infections.
Danish: De må ikke tages sammen med Ilaris, da dette kan øge risikoen for infektioner.
English: The absolute bioavailability of subcutaneously administered canakinumab was estimated to be 66%.
Danish: Den absolutte biotilgængelighed af subkutant administreret canakinumab blev vurderet til 66 %.
English: C-reactive protein ≤ 10 mg/l
Danish: C-reaktivt protein ≤10 mg/l
English: Treatment with canakinumab resulted in clinically relevant improvements in patients' physical function and quality of life.
Danish: Behandling med canakinumab resulterede i klinisk relevant forbedring i patienternes fysiske funktion og livskvalitet.
English: • Muckle-Wells syndrome (MWS),
Danish: • Muckle-Wells syndrom (MWS),
English: No differences in safety or efficacy were observed in patients under the age of 2 years compared with patients aged 2 years and above.
Danish: Der blev ikke observeret nogen forskel i sikkerhed eller virkning hos patienter under 2 år sammenlignet med patienter på 2 år og derover.
English: No human data are available, but as canakinumab is an immunoglobulin of the G class (IgG1), human transplacental transfer is expected.
Danish: Der foreligger ingen humane data, men da canakinumab er et klasse G-immunglobulin (IgG1), forventes human transplancental overførsel.
English: Clinical experience in CAPS patients without a confirmed mutation in the NLRP3 gene is limited.
Danish: Den kliniske erfaring hos CAPS-patienter uden en bekræftet mutation i NLRP3-genet er begrænset.
English: The risk for the development of malignancies with anti-interleukin (IL)-1 therapy is unknown.
Danish: Risikoen for udvikling af malignitet ved anti-interleukin (IL)-1-behandling er ukendt.
English: Of the patients treated with 600 mg or 8 mg/kg (or even higher), 43.8% achieved complete response.
Danish: Af de patienter, der blev behandlet med 600 mg eller 8 mg/kg (eller højere), opnåede 43,8 % fuldt respons.
English: Find a clean place in which to prepare and give yourself the injection.
Danish: Find et rent sted, hvor du kan forberede og give dig selv indsprøjtningen.
English: Women should use effective contraceptives during treatment with canakinumab and for up to 3 months after the last dose.
Danish: Kvinder bør anvende effektiv prævention under behandling med canakinumab og i op til 3 måneder efter den sidste dosis.
English: The study also evaluated the effect of canakinumab on the development of antibodies to standard childhood vaccines.
Danish: Studiet undersøgte også canakinumabs indflydelse på udvikling af antistoffer på standard børnevacciner.
English: If you have gouty arthritis, your treatment will be overseen by a doctor with specialist training.
Danish: Hvis du har urinsyregigt, vil din behandling blive overvåget af en læge med specialviden.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC08
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, interleukinhæmmere, ATC-kode: L04AC08
English: Do not use Ilaris - if you are allergic to canakinumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Ilaris hvis du er allergisk over for canakinumab eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: During clinical development of Ilaris in over 2,600 patients, no anaphylactoid or anaphylactic reactions were reported.
Danish: Under den kliniske udvikling af Ilaris hos over 2.600 patienter blev ingen anafylaktoide eller anafylaktiske reaktioner rapporteret.
English: Patients with Still's disease may develop a condition called macrophage activation syndrome (MAS), which can be life-threatening.
Danish: Patienter med Stills sygdom kan udvikle en tilstand, der kaldes makrofag-aktiverings-syndrom (MAS), som kan være livstruende.
English: If you need another treatment with Ilaris, and got relief from the last dose, you must wait at least 12 weeks before the next dose.
Danish: Hvis du har behov for yderligere behandling med Ilaris og fik lindring ved den sidste dosis, skal du vente mindst 12 uger inden næste dosis.
English: Tell your doctor immediately, if you notice any of the side effects below:
Danish: Fortæl det straks til din læge, hvis du oplever nogen af disse bivirkninger:
English: Your doctor will discuss with you the need to start or adjust a urate lowering therapy to lower the uric acid level in your blood.
Danish: Din læge vil tale med dig om behovet for at starte eller justere en urat-sænkende behandling for at sænke urinsyreniveauet i din krop.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Danish: Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger med hensyn til reproduktionstoksicitet (se pkt.
English: Table 5 Efficacy for the overall study population and in a subgroup of patients currently using ULT and unable to use both NSAIDs and colchicine
Danish: Table 5 Virkning i den totale studiepopulation og i en undergruppe af patienter, der aktuelt får ULT, og som ikke er i stand til at bruge hverken NSAID eller colchicin
English: The mean number of gouty arthritis attacks in the previous 12 months was 6.5.
Danish: Det gennemsnitlige antal urinsyregigtanfald i de foregående 12 måneder var 6,5.
English: Elevations of transaminases have been observed rarely in CAPS patients.
Danish: Forhøjede niveauer af transaminaser er i sjældne tilfælde set hos CAPS-patienter.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Danish: Hvis lægemidlet ikke anvendes straks, er opbevaringstider og -betingelser inden anvendelse brugerens eget ansvar og bør normalt ikke være mere end 24 timer ved 2 °C - 8 °C.
English: Efficacy results for a more stringent subgroup limited to current users of ULT (N=62) are presented in Table 5.
Danish: Effektresultaterne i en mere stringent undergruppe begrænset til patienter i aktuel ULT (N=62) er vist i Tabel 5.
English: Infections of the upper respiratory tract were the most frequently reported infection events.
Danish: Infektioner i de øvre luftveje var den hyppigst indberettede infektion.
English: Women of childbearing potential / Contraception in males and females
Danish: Kvinder i den fertile alder / Kontraception til mænd og kvinder
English: Additionally, 6 paediatric patients under the age of 2 years were evaluated in a small open-label clinical study.
Danish: Desuden blev 6 pædiatriske patienter under 2 år undersøgt i et mindre åbent studie.
English: Canakinumab is associated with an increased incidence of serious infections.
Danish: Canakinumab er forbundet med øget incidens af alvorlige infektioner.
English: Canakinumab binds to serum IL-1 beta.
Danish: Canakinumab bindes til serum IL-1 beta.
English: The estimated steady state AUCtau was 636.7 ± 260.2 μg*d/ml.
Danish: Det estimerede steady state-AUCtau var 636,7 ± 260,2 μg∙dag/ml.
English: There is no significant difference in safety profile observed in patients ≥ 65 years of age.
Danish: Der blev ikke set signifikante forskelle i sikkerhedsprofilen hos patienter ≥65 år.
English: A total of 324 SJIA patients aged 2 to < 20 years have received Ilaris in interventional clinical trials, including 293 patients aged 2 to < 16 years old, 21 patients aged 16 to < 18 years old and 10 patients aged 18 to < 20 years old.
Danish: I alt har 324 SJIA-patienter i alderen 2 til <20 år fået Ilaris i interventionskliniske studier, herunder 293 patienter i alderen 2 til <16 år, 21 patienter i alderen 16 til <18 år og 10 patienter i alderen 18 til <20 år.
English: A total of 185 patients aged 28 days and above were enrolled and a total of 181 patients aged 2 years and above were randomised in part II of the study.
Danish: I alt blev 185 patienter i alderen 28 dage og derover inkluderet, og i alt blev 181 patienter i alderen 2 år og derover randomiseret i studiets del II.
English: Multipack: 4 (4x1) vials.
Danish: Multipakning: 4 (4x1) hætteglas.
English: Accordingly, Tmax was shorter (3.6 days) in younger SJIA patients (2-3 years) compared to older SJIA patients (12-19 years; Tmax 6 days).
Danish: Derfor var Tmax kortere (3,6 dage) hos yngre SJIA-patienter (2-3 år) sammenlignet med ældre SJIA-patienter (12-19 år; Tmax 6 dage).
English: Clinical experience with dosing at intervals of less than 4 weeks or at doses above 600 mg or 8 mg/kg is limited.
Danish: Den kliniske erfaring med dosering i intervaller på mindre end 4 uger eller med doser over 600 mg eller 8 mg/kg er begrænset.
English: Antibodies against Ilaris were observed in approximately 1.5%, 3% and 2% of the patients treated with Ilaris for CAPS, SJIA and gouty arthritis, respectively.
Danish: Antistoffer mod Ilaris er set hos ca. 1,5 %, 3 % og 2 % af patienterne behandlet med Ilaris for henholdsvis CAPS, SJIA og urinsyregigt.
English: Injection into scar tissue should be avoided as this may result in insufficient exposure to canakinumab.
Danish: Injektion i arvæv bør undgås, da det kan medføre utilstrækkelig eksponering af canakinumab.
English: Concomitant treatment with ULTs was reported by 42% of patients at entry.
Danish: Samtidig behandling med ULT blev rapporteret for 42 % af patienterne ved inklusionen.
English: In early clinical trials, patients and healthy volunteers received doses as high as 10 mg/kg, administered intravenously or subcutaneously, without evidence of acute toxicity.
Danish: I tidlige kliniske studier, fik patienter og raske frivillige doser så højt som 10 mg/kg, administreret intravenøst eller subkutant, uden tegn på akut toksicitet.
English: Of the total 128 patients who entered Part I taking corticosteroids, 92 attempted corticosteroid tapering.
Danish: Af i alt 128 patienter, der blev inkluderet i del I og tog kortikosteroider, forsøgte 92 steroidreduktion.
English: - Part I: Patients in each disease cohort aged 2 years and older entered a 12-week screening period during which they were evaluated for the onset of disease flare.
Danish: - Del I: Patienter i hver sygdomskohorte i alderen 2 år og derover indtrådte i en screeningsperiode på 12 uger, hvor de blev evalueret for indtræden af sygdomsopblussen.