FrancophonIA/ELRC3.0 huggingface dataset:
English: The results of a study in healthy adult subjects demonstrated that a single dose of Ilaris 300 mg did not affect the induction and persistence of antibody responses after vaccination with influenza or glycosylated protein based meningococcus vaccines.
Danish: Resultaterne af et studie hos raske voksne forsøgspersoner viste, at en enkelt dosis Ilaris 300 mg ikke påvirkede induktion og persistens af antistofrespons efter vaccination med influenzavaccine eller med meningokokvaccine baseret på glykolyseret protein.
English: 9/l) and leukopenia have been observed with medicinal products that inhibit IL-1, including canakinumab.
Danish: 9/L) og leukopeni er observeret ved lægemidler, der hæmmer IL-1, inklusive canakinumab.
English: Ilaris should be injected by a healthcare professional only.
Danish: Ilaris må kun indsprøjtes af sundhedspersonale.
English: There is a limited amount of data from the use of canakinumab in pregnant women.
Danish: Der foreligger kun begrænsede data om brug af canakinumab hos gravide kvinder.
English: Although limited, evidence from the clinical trials suggests that patients not responding to tocilizumab or anakinra may respond to canakinumab.
Danish: Om end begrænset indikerer evidensen fra kliniske studier, at patienter, der ikke reagerer på tocilizumab eller anakinra, kan reagere på canakinumab.
English: Do not try to administer an injection yourself if you have not been properly trained or if you are not sure how to do it.
Danish: Forsøg ikke selv at give indsprøjtninger, hvis du ikke har fået grundig undervisning i det, eller hvis du er i tvivl om, hvordan du skal gøre.
English: An increased incidence of serious infections has been associated with administration of another IL-1 blocker in combination with TNF inhibitors.
Danish: Øget incidens af alvorlige infektioner er blevet sat i forbindelse med administration af en anden IL-1blokker i kombination med TNF-hæmmere.
English: Patients who do not respond to initial treatment should not be re-treated with canakinumab.
Danish: Patienter, som ikke reagerer på den initiale behandling, bør ikke genbehandles med canakinumab.
English: These data showed similar improvements from baseline to week 12 in the adapted paediatric ACR responses and its components to those observed in the placebo controlled study (G2305).
Danish: Disse data viste lignende forbedringer fra baseline til uge 12 i de tilpassede pædiatriske ACR-respons og komponenter, der blev observeret i det placebokontrollerede studie (G2305).
English: For gouty arthritis, the physician should be experienced in the use of biologics and Ilaris should be administered by a healthcare professional.
Danish: Ved urinsyregigt bør lægen have erfaring med brug af biologiske lægemidler, og Ilaris bør administreres af en sundhedsfaglig person.
English: - Do not use this medicine after the expiry date which is stated on the label and carton.
Danish: Anvend ikke medicinen efter den udløbsdato, der er anført på etiketten og æsken.
English: The apparent volume of distribution (V/F) was 4.96 l at body weight of 55 kg.
Danish: Det tilsyneladende fordelingsvolumen (V/F) var 4,96 l ved en legemsvægt på 55 kg.
English: Gouty arthritis is caused by the formation of urate crystals.
Danish: Urinsyregigt er forårsaget af dannelse af uratkrystaller.
English: NOTE: The required amount depends on the dose to be administered.
Danish: BEMÆRK: Den nødvendige mængde afhænger af, hvilken dosis der skal indsprøjtes.
English: Animal studies indicate that canakinumab crosses the placenta and is detectable in the foetus.
Danish: Dyrestudier indikerer, at canakinumab passerer placenta og kan detekteres hos fostret.
English: Talk to your doctor before using Ilaris if any of the following applies to you: if you currently have an infection or if you have had repeated infections or a condition such as a known low level of white blood cells which makes you more likely to get infections.
Danish: Kontakt lægen, før du tager Ilaris, hvis noget af nedenstående gælder for dig: hvis du i øjeblikket har en infektion eller tidligere har haft tilbagevendende infektioner, eller hvis du fx har et nedsat antal hvide blodlegemer, hvilket gør dig mere modtagelig for infektioner.
English: The causal relationship of canakinumab to these events cannot be excluded.
Danish: Den kausale sammenhæng mellem canakinumab og disse tilfælde kan ikke udelukkes.
English: Primary endpoint (flare) Proportion of patients with disease flare in Part II
Danish: Primært endepunkt (opblussen) Andelen af patienter med sygdomsopblussen i del II
English: If you experience a new attack, your doctor may consider giving you a new dose of Ilaris but not earlier than 12 weeks from the previous dose.
Danish: Hvis du får et nyt anfald, kan din læge overveje at give dig en ny dosis Ilaris, men ikke tidligere end 12 uger efter sidste behandling.
English: Formal studies of the potential effect of canakinumab on human fertility have not been conducted.
Danish: Der er ikke udført formelle undersøgelser af den potentielle virkning af canakinumab på human fertilitet.
English: Periodic fever syndromes
Danish: Periodiske febersyndromer
English: Patients who maintained inactive disease status for 6 additional months at this lowest dose regimen were allowed to discontinue canakinumab.
Danish: Patienter som opretholdte inaktiv sygdomsstatus i yderligere 6 måneder ved den laveste dosis fik lov til at seponere canakinumab.
English: The results of a 56-week, open label study in CAPS patients aged 4 years and younger demonstrated that all patients who received non-live, standard of care childhood vaccinations developed protective antibody levels.
Danish: Resultaterne af et 56 ugers åbent studie hos CAPS-patienter i alderen 4 år og yngre viste, at alle patienter, der fik ikke-levende, standard børnevacciner udviklede beskyttende antistofniveauer.
English: It is unknown whether the use of interleukin-1 (IL-1) inhibitors such as canakinumab increases the risk of reactivation of tuberculosis.
Danish: Det vides ikke, om interleukin-1- (IL-1) hæmmere som fx canakinumab øger risikoen for reaktivering af tuberkulose.
English: If a patient becomes neutropenic or leukopenic, the WBC counts should be monitored closely and treatment discontinuation should be considered.
Danish: Hvis en patient bliver neutropen eller leukopen, skal WBC monitoreres tæt og seponering overvejes.
English: There was no indication of accelerated clearance or time-dependent change in the pharmacokinetic properties of canakinumab following repeated administration.
Danish: Der var intet, der tydede på accelereret clearance eller tidsafhængig ændring i canakinumabs farmakokinetiske egenskaber efter gentagen administration.
English: Based on clinical trial experience, canakinumab does not appear to increase the incidence of MAS in SJIA patients, but no definitive conclusion can be made.
Danish: Baseret på erfaring fra kliniske forsøg påvirker canakinumab tilsyneladende ikke incidencen af MAS hos SJIA-patienter, men en endelig konklusion kan ikke drages.
English: Treatment with canakinumab should not be initiated in patients with neutropenia or leukopenia.
Danish: Behandling med canakinumab bør ikke initieres hos patienter med neutropeni eller leukopeni.
English: Appropriate screening tests (e.g. tuberculin skin test, interferon gamma release assay or chest X-ray) should be performed in all patients (local recommendations may apply).
Danish: Relevante screeningstest (fx tuberkulin hudtest, interferon gamma frigivelsestest eller røntgen af thorax) skal udføres hos alle patienter (lokale anbefalinger kan være gældende).
English: At week 12, the adapted paediatric ACR30, 50, 70, 90 and 100 responses were: 70%, 69%, 61%, 49% and 30%, respectively and 28% of patients had inactive disease (N=178).
Danish: Ved uge 12 var de tilpassede pædiatriske ACR30-, 50-, 70-, 90- og 100-respons henholdsvis 70 %, 69 %, 61 %, 49 % og 30 %, og 28 % af patienterne havde inaktiv sygdom (N=178).
English: Data from the first 12 weeks of canakinumab treatment from studies G2305, G2301 and the extension study were pooled to assess maintenance of efficacy.
Danish: Data fra de første 12 ugers canakinumab-behandling fra studierne G2305 og G2301 og forlængelsesstudiet blev samlet for at vurdere, hvorvidt effekten blev opretholdt.
English: Corticosteroid dose tapering:
Danish: Reduktion af kortikosteroiddosis:
English: The majority of paediatric patients achieved improvement in clinical symptoms and objective markers of inflammation (e.g. SAA and CRP).
Danish: Størstedelen af de pædiatriske patienter opnåede forbedring i kliniske symptomer og objektive inflammationsmarkører (fx SAA og CRP).
English: Part III: Patients treated with placebo in Part II who flared regained and maintained clinical and serological response following entry into the open-label canakinumab extension.
Danish: Del III: Patienter, der blev behandlet med placebo i del II, og som havde opblussen, genvandt og opretholdt klinisk og serologisk respons efter indtræden i den åbne studieudvidelse med canakinumab.
English: This is clinically relevant for CYP450 substrates with a narrow therapeutic index where the dose is individually adjusted.
Danish: Dette er klinisk relevant for CYP-substrater med et snævert terapeutisk vindue, hvor dosis justeres individuelt.
English: Ilaris is intended for subcutaneous use.
Danish: Ilaris er beregnet til subkutan anvendelse.
English: The co-primary endpoints were: (i) gouty arthritis pain intensity (visual analogue scale, VAS) at 72 hours post-dose, and (ii) time to first new gouty arthritis attack.
Danish: Det sammensatte primære endepunkt var: (I) urinsyregigt-smerteintensitet (visual analogue scale, VAS) 72 timer efter indtagelse, og (II) tid til første nye anfald af urinsyregigt.
English: The other was an open-label study with canakinumab to evaluate the efficacy and safety in Japanese CAPS patients for 24 weeks, with an extension phase up to 48 weeks.
Danish: Det andet studie var et open-label studie med canakinumab for at vurdere effekten og sikkerheden hos japanske CAPS-patienter i 24 uger, med en ekstensionsfase op til 48 uger.
English: Canakinumab had no effect on male fertility parameters in marmosets (C. jacchus).
Danish: Canakinumab havde ingen effekt på de mandlige fertilitetsparametre hos egernaber (C. jacchus).
English: (There may be solution remaining in the vial.)
Danish: (Der kan være opløsning tilbage i hætteglasset).
English: Isolated cases of unusual or opportunistic infections (including aspergillosis, atypical mycobacterial infections, herpes zoster) have been reported during canakinumab treatment.
Danish: Isolerede tilfælde af usædvanlige eller opportunistiske infektioner (inklusive aspergillose, atypiske mycopakterielle infektioner, herpes zoster) er rapporteret under behandling med canakinumab.
English: Fifty-seven (62%) of the 92 patients who attempted to taper were able to successfully taper their corticosteroid dose and 42 (46%) discontinued corticosteroids.
Danish: 57 (62 %) af de 92 patienter, der forsøgte steroidreduktion, var i stand til successfuldt at reducere deres kortikosteroiddosis, og 42 (46 %) stoppede med kortikosteroider.
English: For the overall study population, pain intensity was statistically significantly lower for canakinumab 150 mg compared with triamcinolone acetonide at 72 hours.
Danish: For den totale studiepopulation var smerteintensiteten statistisk signifikant lavere for canakinumab 150 mg sammenlignet med triamcinolonacetonid ved 72 timer.
English: Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with rheumatic conditions, in particular Still's disease.
Danish: Makrofag-aktiveringssyndrom (MAS) er en kendt, livstruende tilstand, der kan udvikles hos patienter med reumatiske lidelser, specielt Stills sygdom.
English: For the primary efficacy endpoint, canakinumab was superior to placebo for all three disease cohorts.
Danish: Hvad angik det primære effektendepunkt, var canakinumab superior i forhold til placebo for alle tre sygdomskohorter.
English: Approximately one-third of the patients enrolled (76 [33.8%] in the canakinumab group and 84 [36.7%] in the triamcinolone acetonide group) had documented inability (intolerance, contraindication or lack of response) to use both NSAIDs and colchicine.
Danish: Omkring en tredjedel af de inkluderede patienter (76 [33,8 %] i canakinumab-gruppen og 84 [36,7 %] i triamcinolonacetonid-gruppen) var dokumenteret ikke i stand (intolerance, kontraindikationer eller manglende respons) til at bruge hverken NSAID eller colchicin.
English: Seventeen patients (including 6 patients under the age of 2 years) were evaluated, using weight-based starting doses of 2-8 mg/kg.
Danish: 17 patienter (inklusive 6 patienter under 2 år) blev evalueret; vægtbaserede startdoser var 2-8 mg/kg.
English: It was estimated to be 6.2 litres in a CAPS patient of body weight 70 kg.
Danish: Det blev estimeret til 6,2 liter hos en CAPS-patient med en legemsvægt på 70 kg.
English: It is recommended to select a different injection site each time the product is injected to avoid soreness.
Danish: Det anbefales at vælge et nyt injektionssted ved hver injektion for at undgå ømhed.
English: The needle should not be in the liquid at this point.
Danish: Nålen skal ikke være nede i injektionsvæsken på dette tidspunkt.
English: The pivotal study consisted of a 48-week three-part multicentre study, i.e. an 8-week open-label period (Part I), a 24-week randomised, double-blind, placebo-controlled withdrawal period (Part II), followed by a 16-week open-label period (Part III).
Danish: Det pivotale studie bestod af et tredelt multicenterstudie på 48 uger, dvs. en åben periode på 8 uger (del I), en randomiseret, dobbeltblindet, placebokontrolleret seponeringsperiode på 24 uger (del II), efterfulgt af en åben periode på 16 uger (del III).
English: This patient presented at study entry with a history of immune thrombocytopenic purpura and an active medical condition of abnormal hepatic function.
Danish: Denne patient indtrådte i studiet med immun trombocytopenisk purpura i anamnesen og en aktiv klinisk tilstand med anormal leverfunktion.
English: Laboratory parameters such as high CRP and SAA, high neutrophils and platelet counts normalised rapidly within days of canakinumab injection.
Danish: Laboratorieparametre, såsom højt niveau af CRP og SAA, høje neutrofil- og trombocyttal, normaliseredes hurtigt inden for nogle dage efter injektion af canakinumab.
English: - Part IV: All Part III patients treated with canakinumab were eligible to enter into a 72-week open-label treatment extension period.
Danish: - Del IV: Alle patienter fra del III, der blev behandlet med canakinumab, var egnede til at indtræde i en forlænget åben behandlingsperiode på 72 uger.
English: Stopping your treatment with Ilaris may cause your condition to get worse.
Danish: Hvis du stopper behandlingen med Ilaris, kan din tilstand forværres.
English: Still's disease (AOSD and SJIA)
Danish: Stills sygdom (AOSD og SJIA)
English: In patients with periodic fever syndromes (CAPS, TRAPS, HIDS/MKD and FMF), the body produces too much IL-1 beta.
Danish: Hos patienter med periodiske febersyndromer (CAPS, TRAPS, HIDS/MKD og FMF) danner kroppen for meget IL-1 beta.
English: It is unknown whether canakinumab is excreted in human milk.
Danish: Det vides ikke, om canakinumab udskilles i human mælk.
English: Prior to initiation of canakinumab therapy it is recommended that adult and paediatric patients receive all vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine (see section 4.5).
Danish: Inden initiering af canakinumab-behandling anbefales det, at voksne og pædiatriske patienter får alle hensigtsmæssige vaccinationer, herunder også pneumokokvaccine og inaktiveret influenzavaccine (se pkt.
English: Resolution of disease flare was achieved by week 5 and the patient had not experienced any new flare at the end of Part II of the study (week 16).
Danish: Ophør af sygdomsopblussen blev opnået ved uge 5, og patienten havde ikke fået nogen ny opblussen ved afslutning af studiets del II (uge 16).
English: Never re-use syringes or needles.
Danish: Genbrug aldrig sprøjter eller kanyler.
English: Each vial is for single use in a single patient, for a single dose.
Danish: Hvert hætteglas er til engangsbrug og indeholder en enkelt dosis til én patient.
English: Although approximately 22% of patients receiving canakinumab required dose adjustment, only a small percentage of patients (1.2%) discontinued canakinumab due to lack of therapeutic effect.
Danish: Omkring 22% af patienterne der fik canakinumab krævede dosisjustering, men kun en lille procentdel (1,2%) ophørte med canakinumab på grund af manglende terapeutisk effekt.
English: Broken skin and areas which are bruised or covered by a rash should be avoided.
Danish: Beskadiget hud og områder med blå mærker eller udslæt bør undgås.
English: Gouty arthritis: Ilaris is not recommended for children or adolescents under 18 years of age.
Danish: Urinsyregigt: Ilaris frarådes til børn og unge under 18 år.
English: The efficacy of canakinumab for the treatment of active SJIA was assessed in two pivotal studies (G2305 and G2301).
Danish: Virkningen af canakinumab ved aktiv SJIA blev vurderet i to pivotale studier (G2305 og G2301).
English: From a microbiological point of view, the product should be used immediately after first opening.
Danish: Ud fra en mikrobiologisk betragtning skal lægemidlet anvendes straks efter åbning.
English: After reconstitution, from a microbiological point of view, the product should be used immediately.
Danish: Efter rekonstitution bør lægemidlet ud fra en mikrobiologisk betragtning anvendes straks.
English: Physicians should exercise caution when administering canakinumab to patients with infections, a history of recurring infections, or underlying conditions which may predispose them to infections.
Danish: Læger bør udvise forsigtighed ved administration af canakinumab til patienter med aktuel infektion, anamnestiske oplysninger om tilbagevendende infektioner, eller underliggende tilstande, der kan prædisponere for infektioner.
English: Although ≥ Grade 2 reductions in neutrophil count occurred in 6.5% of patients (common) and Grade 1 reductions occurred in 9.5% of patients, the reductions are generally transient and neutropenia-associated infection has not been identified as an adverse reaction.
Danish: Selvom der forekom reduktion i neutrofiltallet af ≥grad 2 hos 6,5 % af patienterne (almindelig) og reduktion af grad 1 hos 9,5 % af patienterne, er nedsat neutrofiltal generelt forbigående, og neutropeni-relateret infektion er ikke blevet identificeret som en bivirkning.
English: The AUCss4w in each age group was 692, 615, 707 and 742 µg*d/ml for 2-3, 4-5, 6-11, and 12-19 years old, respectively.
Danish: AUCSS i de enkelte aldersgrupper var 692, 615, 707 og 742 µg*dag/ml for henholdsvis 2-3, 4-5, 6-11 og 12-19 år.
English: You are advised to avoid becoming pregnant and must use adequate contraception while using Ilaris and for at least 3 months after the last Ilaris treatment.
Danish: Du frarådes at blive gravid og skal anvende sikker prævention, mens du tager Ilaris og i mindst 3 måneder efter den sidste Ilaris-behandling.
English: The patient or caregiver and the doctor should decide together who will administer the Ilaris injections.
Danish: Patienten, plejepersonen og lægen bør i fællesskab beslutte, hvem der skal indsprøjte Ilaris.
English: Disease activity was rated as absent or mild/moderate in more than 90% of patients at all post-baseline time points in the study, and median serological markers of inflammation (CRP and SAA) were normal (< 10 mg/litre) at all post-baseline time points.
Danish: Sygdomsaktiviten blev bedømt som fraværende eller mild/moderat for mere end 90% af patienterne for alle post-baseline tidspunkter i studiet, og medianen af serologiske markører for inflammation (CRP og SAA) var normal (<10 mg/l) for alle post-baseline tidspunkter.
English: These crystals cause excessive production of IL-1 beta, which in turn can lead to sudden, severe pain, redness, warmth and swelling in a joint (known as a gouty arthritis attack).
Danish: Disse krystaller forårsager overdreven produktion af IL-1 beta, som til gengæld kan medføre pludselig, kraftig smerte, rødme, varme og hævelse i et led (kendt som podagra).
English: After removing the vial from the refrigerator, check the expiry date on the vial.
Danish: Tag hætteglasset ud af køleskabet og kontroller udløbsdatoen på hætteglasset.
English: The Marketing Authorisation Holder has completed four Paediatric Investigation Plans for Ilaris (for CAPS, SJIA, FMF - HIDS/MKD and TRAPS respectively).
Danish: Indehaveren af markedsføringstilladelsen har gennemført fire pædiatriske undersøgelsesprogrammer for Ilaris (for henholdsvis CAPS, SJIA, FMF - HIDS/MKD og TRAPS).
English: Canakinumab also demonstrated superior efficacy compared to placebo on the secondary endpoints of PGA < 2 and CRP ≤ 10 mg/l in all three cohorts.
Danish: Canakinumab havde også en superior effekt sammenlignet med placebo på de sekundære endepunkter PGA <2 og CRP ≤10 mg/l i alle tre kohorter.
English: 1 In SJIA
Danish: 1Ved SJIA.
English: Ilaris can be used alone or in combination with methotrexate.
Danish: Ilaris kan anvendes alene eller sammen med methotrexat.
English: Do not try to heat the vial.
Danish: Du må ikke prøve at opvarme hætteglasset.
English: The mean change in pain score among canakinumab treated patients was consistent at day 29.
Danish: Den mediane ændring i smertescore hos canakinumab-behandlede patienter var vedvarende på dag 29.
English: There were no antibodies against Ilaris observed in TRAPS, HIDS/MKD and FMF patients treated with doses of 150 mg and 300 mg over 16 weeks of treatment.
Danish: Der blev ikke observeret antistoffer mod Ilaris hos TRAPS-, HIDS/MKD- og FMF-patienter, som blev behandlet med doser på 150 mg og 300 mg over en 16 ugers behandlingsperiode.
English: Live vaccines: You are advised to avoid being vaccinated with a type of vaccine called a live vaccine while you are being treated with Ilaris.
Danish: Levende vacciner: Det anbefales, at du undgår at blive vaccineret med en type vacciner, der kaldes ”levende vacciner”, mens du bliver behandlet med Ilaris.
English: Your baby should not receive live vaccines until at least 16 weeks after you received your last dose of canakinumab before giving birth.
Danish: Dit barn må ikke få levende vacciner før mindst 16 uger efter, at du har fået din sidste dosis af canakunimab før fødslen.
English: SJIA in young adults and AOSD
Danish: SJIA hos unge patienter og AOSD
English: See also section 3, “Injecting Ilaris yourself or injecting a patient with Ilaris”.
Danish: Se også punkt 3, ”Hvis du giver dig selv indsprøjtning af Ilaris eller giver en patient Ilaris”.
English: In the overall study population, patients on ULT had a less pronounced treatment difference in both pain reduction and reduction in the risk of subsequent gouty arthritis attacks compared to patients not on ULT.
Danish: I den totale studiepopulation havde patienter på ULT en mindre udtalt behandlingsforskel i både smertereduktion og reduktion af risikoen for efterfølgende urinsyregigt-anfald sammenlignet med patienter, der ikke var på ULT.
English: Your doctor may check whether you have tuberculosis using a specific test. if you have signs of a liver disorder such as yellow skin and eyes, nausea, loss of appetite, darkcoloured urine and light-coloured stools.
Danish: Din læge vil muligvis kontrollere, om du har tuberkulose, ved brug af en specifik test. hvis du har symptomer på en leversygdom som fx gul hud og øjne, kvalme, appetitløshed, mørk urin og lys afføring.
English: The doctor or nurse will demonstrate how to administer Ilaris injections.
Danish: Lægen eller sygeplejersken vil vise dig, hvordan indsprøjtninger med Ilaris skal gives.
English: Familial Mediterranean fever (FMF)
Danish: Familiær middelhavsfeber (FMF)
English: A new flare was defined as a PGA score ≥ 2 (“mild, moderate, or severe disease”) and CRP ≥ 30 mg/l.
Danish: En ny opblussen blev defineret som en PGA-score ≥ 2 (let, moderat eller svær sygdom) og CRP ≥30 mg/l.