FrancophonIA/ELRC3.0 huggingface dataset:
English: The distribution volume (Vss) of canakinumab varied according to body weight.
Danish: Canakinumabs fordelingsvolumen (Vss) varierede i forhold til legemsvægt.
English: Safety results showed an increased incidence of adverse events for canakinumab compared to triamcinolone acetonide, with 66% vs 53% of patients reporting any adverse event and 20% vs 10% of patients reporting an infection adverse event over 24 weeks.
Danish: Sikkerhedsresultaterne viste en øget forekomst af bivirkninger for canakinumab sammenlignet med triamcinolonacetonid med 66 % henholdsvis 53 % af patienterne, der rapporterede en hvilken som helst bivirkning, og 20 % henholdsvis 10 % af patienterne, der rapporterede en infektionsrelateret bivirkning i løbet af 24 uger.
English: Drop in level of white blood cells which help prevent infection (neutropenia).
Danish: Nedsat antal hvide blodlegemer, som forebygger infektioner (neutropeni).
English: Should vaccination with live vaccines be indicated after initiation of canakinumab treatment, the recommendation is to wait for at least 3 months after the last canakinumab injection and before the next one (see section 4.4).
Danish: Hvis vaccination med levende vacciner er indiceret efter initiering af canakinumab-behandling, anbefales det at vente mindst 3 måneder efter den sidste canakinumab-injektion og før den næste injektion (se pkt.
English: Secondary endpoints, all based on week 16 results (end of Part II), included the proportion of patients who achieved a PGA score of < 2, the proportion of patients with serological remission (defined as CRP ≤ 10 mg/l), and the proportion of patients with a normalised SAA level (defined as SAA ≤ 10 mg/l).
Danish: Sekundære endepunkter var alle baseret på resultater ved uge 16 (afslutningen af del II) og omfattede andelen af patienter, der opnåede PGA-score <2, andelen af patienter med serologisk remission (defineret som CRP ≤10 mg/l) og andelen af patienter med normaliseret SAA-niveau (defineret som SAA ≤10 mg/l).
English: Abnormal levels of triglycerides in your blood (lipid metabolism disorder).
Danish: Unormalt niveau af triglycerider i blodet (forstyrrelser i lipidstofskiftet).
English: The safety profile of canakinumab observed following long-term treatment in this setting was consistent with what has been observed in interventional studies in CAPS patients.
Danish: Sikkerhedsprofilen for canakinumab, der blev observeret efter langtidsbehandling under disse forhold, svarede til den sikkerhedsprofil der blev observeret i interventionsstudier i CAPS patienter.
English: Treatment with canakinumab induced a reduction of pain and reduced the risk of subsequent attacks in patients using ULT and unable to use both NSAIDs and colchicine, although the observed treatment difference compared to triamcinolone acetonide was less pronounced than with the overall study population.
Danish: Behandling med canakinumab inducerede en smertereduktion og reducerede risikoen for efterfølgende anfald hos patienter, der fik ULT, og som ikke kunne bruge hverken NSAID eller colchicin, selvom den observerede behandlingsforskel sammenlignet med triamcinolonacetonid var mindre udtalt end for den totale studiepopulation.
English: No dose adjustment is needed in patients with renal impairment.
Danish: Der er ikke behov for dosisjustering hos patienter med nedsat nyrefunktion.
English: It is not known whether Ilaris passes into human milk.
Danish: Det vides ikke, om Ilaris udskilles i mælken hos mennesker.
English: Let the vial stand unopened for 10 minutes to bring the contents to room temperature.
Danish: Lad hætteglasset stå uåbnet i 10 minutter, så indholdet kan opnå stuetemperatur.
English: In approximately 12% of CAPS patients tested with a PPD (purified protein derivative) skin test in clinical trials, follow-up testing yielded a positive test result while treated with canakinumab without clinical evidence of a latent or active tuberculosis infection.
Danish: Hos ca. 12 % af de CAPS-patienter, der blev testet med en tuberkulintest (purified protein derivative (PPD)) i kliniske forsøg, gav opfølgende test et positivt resultat under behandling med canakinumab uden klinisk evidens for en latent eller aktiv tuberkuloseinfektion.
English: In the pooled efficacy analysis for these two studies, 65.6% of patients who had not previously been treated with canakinumab achieved complete response at 150 mg or 2 mg/kg, while 85.2% of patients achieved complete response at any dose.
Danish: I en samlet effektanalyse af disse to studier opnåede 65,6 % af de patienter, der ikke tidligere var blevet behandlet med canakinumab, fuldt respons ved 150 mg eller 2 mg/kg, mens 85,2 % af patienterne opnåede fuldt respons ved en hvilken som helst dosis.
English: Part I: A complete clinical and biomarker response to canakinumab (defined as composite of physician's global assessment on autoinflammatory and on skin disease ≤ minimal and CRP or SAA values < 10 mg/litre) was observed in 97% of patients and appeared within 7 days of initiation of treatment.
Danish: Del I: Et fuldstændigt klinisk og biomarkørmæssigt respons på canakinumab (defineret som sammensætning af dels en samlet lægelig vurdering af autoinflammatorisk sygdom og dels af hudsygdom ≤ minimal og CRP- eller SAA-værdier <10 mg/liter) sås hos 97 % af patienterne og viste sig inden for 7 dage efter indledning af behandlingen.
English: Therefore, live vaccines should not be given concurrently with canakinumab unless the benefits clearly outweigh the risks.
Danish: Levende vacciner bør derfor ikke gives sideløbende med canakinumab, medmindre fordelene tydeligt opvejer risici.
English: Your doctor will discuss with you the potential risks of taking Ilaris during pregnancy.
Danish: Din læge vil tale med dig om de mulige risici, der er ved at tage Ilaris under graviditeten.
English: The reconstituted solution should ideally be used immediately, but can still be used for up to 24 hours if stored in a refrigerator.
Danish: Den rekonstituerede injektionsvæske bør anvendes straks, men kan anvendes inden for 24 timer, hvis den opbevares i køleskab.
English: Two non-randomised HIDS/MKD patients aged > 28 days but < 2 years were included in the study and received canakinumab.
Danish: To ikke-randomiserede HIDS/MKD-patienter i alderen >28 dage, men <2 år blev inkluderet i studiet og fik canakinumab.
English: Neutropenia (absolute neutrophil count [ANC] < 1.5 x 10
Danish: Neutropeni (absolut neutrofiltal [ANC] <1,5 x 10
English: This means that it is injected through a short needle into the fatty tissue just under the skin.
Danish: Det betyder, at det bliver sprøjtet ind i fedtvævet lige under huden med en kort kanyle.
English: Make sure all of the solution is in the bottom of the vial.
Danish: Kontrollér, at al opløsningen er i bunden af hætteglasset.
English: Based on the population pharmacokinetic modelling analysis, the expected exposures after a dose of 2 mg/kg were comparable across the CAPS paediatric age groups, but were approximately 40% lower in paediatric patients of very low body weight (e.g. 10 kg) than in adult patients (150 mg dose).
Danish: Baseret på en populationsfarmakokinetisk modelleringsanalyse var de forventede eksponeringer efter en dosis på 2 mg/kg sammenlignelige på tværs af CAPS-pædiatriske aldersgrupper, men var omkring 40 % lavere hos pædiatriske patienter med meget lav kropsvægt (fx 10 kg) end hos voksne patienter (150 mg dosis).
English: In clinical studies, canakinumab has been safely administered with ULT.
Danish: I kliniske studier er canakinumab blevet sikkert administreret sammen med ULT.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of crossreactivity, repeated dose toxicity, immunotoxicity, toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle undersøgelser af krydsreaktivitet, toksicitet efter gentagne doser, immunotoksicitet, reproduktions- og udviklingstoksicitet.
English: Significant improvements were seen in physician's clinical assessment of autoinflammatory disease activity: global assessment of autoinflammatory disease activity, assessment of skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, assessment of other related symptoms, and patient's assessment of symptoms.
Danish: Der sås signifikante forbedringer af den lægelige kliniske vurdering af autoinflammatorisk sygdomsaktivitet: samlet vurdering af autoinflammatorisk sygdomsaktivitet, vurdering af hudsygdom (urtikarielt hududslæt), artralgi, myalgi, hovedpine/migræne, konjunktivitis, træthed/utilpashed, vurdering af andre relaterede symptomer og af patientens vurdering af symptomer.
English: • Familial Mediterranean fever (FMF).
Danish: • Familiær middelhavsfeber (FMF).
English: In patients who respond and require re-treatment, there should be an interval of at least 12 weeks before a new dose of canakinumab may be administered (see section 5.2).
Danish: Hos patienter, hvor lægemiddelet virker, og som har behov for genbehandling, bør der være et interval på mindst 12 uger, inden en ny dosis canakinumab administreres (se pkt.
English: Sixty-three of the 100 patients entering Part II, whether assigned to placebo or canakinumab, did not experience a flare over the observation period (up to a maximum of 80 weeks).
Danish: 63 ud af de 100 patienter, der blev inkluderet i del II, og som fik enten placebo eller canakinumab, oplevede ikke udbrud i observationsperioden (op til maksimalt 80 uger).
English: Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:
Danish: Ilaris er indiceret til behandling af følgende autoinflammatoriske periodiske febersyndromer hos voksne, unge og børn på 2 år og derover:
English: Activation of macrophages and concomitant over-production of IL-1 beta results in an acute painful inflammatory response.
Danish: Aktivering af makrofager og samtidig overproduktion af IL-1 beta resulterer i et akut smertefuldt inflammatorisk respons.
English: In the long-term, open-label studies with dose escalation, events of infections (gastroenteritis, respiratory tract infection, upper respiratory tract infection), vomiting and dizziness were more frequently reported in the 600 mg or 8 mg/kg dose group than in other dose groups.
Danish: I længerevarende, open-label studier med dosisoptrapning blev infektioner (gastroenteritis, luftvejsinfektion, infektion i de øvre luftveje), opkastning og svimmelhed rapporteret hyppigere i gruppen med dosis på 600 mg eller 8 mg/kg sammenlignet med andre grupper.
English: Candida - vaginal yeast infection (vulvovaginal candidiasis).
Danish: Svampeinfektion i skeden (vulvovaginal candidiasis).
English: The efficacy and safety of canakinumab have been demonstrated in a total of 211 adult and paediatric patients with varying degrees of disease severity and different CAPS phenotypes (including FCAS/FCU, MWS, and NOMID/CINCA).
Danish: Canakinumab's effekt og sikkerhed er påvist hos i alt 211 voksne og pædiatriske patienter med varierende sygdomssværhedsgrader og forskellige CAPS-fænotyper (herunder FCAS/FCU, MWS og NOMID/CINCA).
English: You are advised to avoid being vaccinated with a type of vaccine called a live vaccine while being treated with Ilaris (see also “Other medicines and Ilaris”).
Danish: Det anbefales, at du undgår at blive vaccineret med en type vacciner, der kaldes levende vacciner, mens du bliver behandlet med Ilaris (se også ”Brug af anden medicin sammen med Ilaris”).
English: The most frequent adverse drug reactions were infections predominantly of the upper respiratory tract.
Danish: De hyppigste bivirkninger var infektioner, hovedsageligt i øvre luftveje.
English: This is administered every eight weeks as a single dose via subcutaneous injection.
Danish: Denne dosis administreres hver ottende uge som en enkelt dosis via subkutan injektion.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Danish: 6.6 for anvisninger i rekonstruktion af lægemidlet før administration.
English: Instructions for administration
Danish: Instruktioner vedrørende administration
English: Asymptomatic and mild elevations of serum bilirubin have been observed in CAPS patients treated with canakinumab without concomitant elevations of transaminases.
Danish: Asymptomatisk, let forhøjelse af bilirubin i serum er observeret hos CAPS-patienter, der blev behandlet med canakinumab, uden samtidig forhøjelse af niveauet af transaminaser.
English: Part II: In the withdrawal period of the pivotal study, the primary endpoint was defined as the proportion of patients with a disease relapse/flare: none (0%) of the patients randomised to canakinumab flared, compared with 81% of the patients randomised to placebo.
Danish: Del II: I det pivotale studies seponeringsperiode var det primære endepunkt andelen af patienter med sygdomstilbagefald/opblussen: ingen (0 %) af de patienter, der var randomiseret til canakinumab havde opblussen, sammenlignet med 81 % af de patienter, der var randomiseret til placebo.
English: Ilaris is available in packs containing one vial or multipacks comprising four intermediate packs, each containing one vial.
Danish: - Ilaris fås i pakninger med ét hætteglas eller multipakninger bestående af fire delpakninger, der hver indeholder et hætteglas.
English: Cryopyrin-associated periodic syndromes
Danish: Kryopyrin-associerede periodiske syndromer
English: The apparent clearance (CL/F) of canakinumab increases with body weight.
Danish: Canakinumabs tilsyneladende clearance (CL/F) stiger med stigende legemsvægt.
English: Higher proportions of patients had normalised SAA (≤ 10 mg/l) at week 16 with canakinumab treatment compared to placebo in all three cohorts, with a statistically significant difference observed in TRAPS patients (see Table 3 with study results below).
Danish: En større andel af patienter havde normaliseret SAA (≤10 mg/l) ved uge 16 med canakinumab-behandling sammenlignet med placebo i alle tre kohorter med en statistisk signifikant forskel observeret hos TRAPS-patienter (se tabel 3 med studieresultater nedenfor).
English: Your doctor may want to check your vaccination history and give you any vaccinations that you have missed before you start treatment with Ilaris.
Danish: Din læge vil muligvis kontrollere, hvilke vaccinationer du tidligere har fået og give dig de vaccinationer, du måtte mangle, inden din behandling med Ilaris begynder.
English: Without touching the rubber stopper, swirl (do not shake) the vial slowly at an angle of about 45 degrees for about 1 minute.
Danish: Sving langsomt hætteglasset rundt (det må ikke rystes), uden at berøre gummiproppen, i en vinkel på omkring 45 grader i ca. 1 minut.
English: Periodic fever syndromes Ilaris is used in adults and children aged 2 years and older to treat the following: - Cryopyrin-associated periodic syndromes (CAPS) - this is a group of auto-inflammatory diseases, which include:
Danish: Periodiske feber-syndromer Ilaris anvendes til voksne og børn på 2 år og derover til behandling af følgende: - Kryopyrin-associerede periodiske syndromer (CAPS) - dette er en gruppe af autoinflammatoriske sygdomme, der omfatter:
English: Patients enrolled were aged 2 to < 20 years (mean age of 8.5 years and mean disease duration of 3.5 years at baseline) and had active disease defined as ≥ 2 joints with active arthritis, fever and elevated CRP.
Danish: De inkluderede patienter var 2 til <20 år (gennemsnitsalderen var 8,5 år, og gennemsnitlig sygdomsvarighed var 3,5 år ved baseline) og havde aktiv sygdom defineret som ≥2 led med aktiv artritis, feber og forhøjet C-reaktivt protein.
English: Study G2301 was a randomised, double-blind, placebo-controlled withdrawal study of flare prevention by canakinumab.
Danish: Studie G2301 var et randomiseret, dobbelblindet, placebokontrolleret seponeringsstudie til forebyggelse af udbrud med canakinumab.
English: If you received canakinumab while you were pregnant, it is important that you inform the baby's doctor or nurse before any vaccinations are given to your baby.
Danish: Hvis du har været i behandling med canakinumab under din graviditet, er det vigtigt, at du informerer barnets læge eller sygeplejerske, før dit barn skal vaccineres.
English: Ilaris contains the active substance canakinumab, a monoclonal antibody that belongs to a group of medicines called interleukin inhibitors.
Danish: Ilaris indeholder det aktive stof canakinumab, et monoklonalt antistof, der tilhører en lægemiddelgruppe, der hedder interleukinhæmmere.
English: A total of 243 CAPS patients (85 paediatric patients aged ≥ 2 to ≤ 17 years and 158 adult patients aged ≥ 18 years) were treated with canakinumab in routine clinical practice in a long-term registry study (mean of 3.8 years of canakinumab exposure).
Danish: I alt blev 243 CAPS patienter (85 pædiatriske patienter i alderen ≥2 til ≤17 år og 158 voksne patienter i alderen ≥18 år) behandlet med canakinumab i henhold til rutine klinisk praksis i et langtidsregisterstudie (middeleksponeringstid for canakinumab var 3,8 år).
English: Exposure parameters (such as AUC and Cmax) increased in proportion to dose over the dose range of 0.30 to 10.0 mg/kg given as intravenous infusion or from 150 to 600 mg as subcutaneous injection.
Danish: Eksponeringsparametre (fx AUC og Cmax) steg i forhold til dosis i dosisintervallet 0,30 til 10,0 mg/kg, givet som intravenøs infusion, og fra 150 til 600 mg, givet som subkutan injektion.
English: A total of 225 patients were treated with subcutaneous canakinumab 150 mg and 229 patients were treated with intramuscular triamcinolone acetonide (TA) 40 mg at study entry, and when experiencing a new attack thereafter.
Danish: Totalt 225 patienter blev behandlet med canakinumab 150 mg subkutant, og 229 patienter blev behandlet med intramuskulært triamcinolonacetonid (TA) 40 mg ved studiestart og efterfølgende ved hvert nyt anfald.
English: Your doctor will monitor you for potential triggering factors of MAS that include infections and re-activation of the underlying Still's disease (flare).
Danish: Din læge vil overvåge dig for mulige faktorer, der kan udløse MAS, fx infektioner og reaktivering af Stills sygdom (udbrud).
English: Animal studies have shown that a murine anti-murine IL-1 beta antibody had no undesirable effects on development in nursing mouse pups and that the antibody was transferred to them (see section 5.3).
Danish: Dyrestudier har vist, at et murint anti-murin IL-1 beta-antistof ikke havde uønskede virkninger på diende museungers udvikling, og at antistoffet blev overført til dem (se pkt.
English: Tuberculosis screening
Danish: Tuberkulosescreening
English: Do not inject air into the liquid.
Danish: Der må ikke sprøjtes luft ned i væsken.
English: Triglycerides
Danish: Triglycerider
English: In the Phase I/II study, treatment with canakinumab had a rapid onset of action, with disappearance or clinically significant improvement of symptoms within one day after dosing.
Danish: I fase I/II-studiet satte virkningen af canakinumab-behandlingen hurtigt ind, således at symptomerne forsvandt eller bedredes klinisk signifikant inden for en dag efter dosering.
English: Of the patients in clinical remission who continued with further dose reduction (1 mg/kg every 4 weeks) or dose interval prolongation (4 mg/kg every 12 weeks), 93% (26/28) and 91% (30/33) of patients, respectively, were able to maintain inactive disease status for 6 months.
Danish: Hos patienter i klinisk remission, som fortsatte med yderligere dosisreduktion (1 mg/kg hver 4. uge), eller forlængelse af dosisinterval (4 mg/kg hver 12. uge), kunne henholdsvis 93 % (26/28) og 91 % (30/33) af patienterne opretholde inaktiv sygdomsstatus i 6 måneder.
English: However, the risk of severe hypersensitivity reactions, which is not uncommon for injectable proteins, cannot be excluded (see section 4.3).
Danish: Det kan dog ikke udelukkes, at der er risiko for alvorlige overfølsomhedsreaktioner, hvilket ikke er ualmindeligt for injicerbare proteiner (se pkt.
English: Clean the injection site with a new alcohol swab.
Danish: Rens indsprøjtningsstedet med en ny spritserviet.
English: The aim of the study was to assess efficacy, safety, and tolerability of canakinumab (150 mg or 2 mg/kg every 8 weeks) in patients with CAPS.
Danish: Formålet med studiet var at vurdere effekt, sikkerhed og tolerabilitet af canakinumab (150 mg eller 2 mg/kg hver 8. uge) hos patienter med CAPS.
English: Management of hyperuricaemia with appropriate urate lowering therapy (ULT) should be instituted or optimised.
Danish: Hyperurikæmi bør håndteres med påbegyndelse eller optimering af passende urat-sænkende behandling (ULT).
English: Drop in level of white blood cells (leukopenia).
Danish: Nedsat antal hvide blodlegemer (leukopeni).
English: No data are available on either the effects of live vaccination or the secondary transmission of infection by live vaccines in patients receiving canakinumab.
Danish: Der findes ingen tilgængelige data vedrørende effekten af levende vacciner eller sekundær overførsel af infektioner via levende vacciner hos patienter, der får canakinumab.
English: Find a clean place in which to prepare and administer the injection.
Danish: Find et rent sted, hvor du kan forberede og foretage indsprøjtningen.
English: Ilaris has not been studied in patients with hepatic impairment.
Danish: Ilaris er ikke undersøgt hos patienter med nedsat leverfunktion.
English: Formal carcinogenicity studies have not been conducted with canakinumab.
Danish: Der er ikke foretaget formelle karcinogenicitetsstudier med canakinumab.
English: For children given a starting dose of 4 mg/kg who have not responded well enough after 7 days, the doctor may give a second dose of 4 mg/kg.
Danish: Hos børn, der får en startdosis på 4 mg/kg, og hvor kroppen ikke har reageret godt nok efter 7 dage, kan lægen give endnu en dosis på 4 mg/kg.
English: A 6-year observational registry study was conducted to provide data on the long-term safety and effectiveness of canakinumab treatment in paediatric and adult CAPS patients in routine clinical practice.
Danish: Et 6 års observationelt registerstudie blev gennemført for at generere data for langtidssikkerhed ogeffektivitet for pædiatriske og voksne CAPS patienter i rutine klinisk praksis.
English: In another study, among patients who were starting on ULT, increases in uric acid were not observed.
Danish: I et andet studie blev der ikke observeret stigning i urinsyre blandt patienter, som startede på ULT.
English: Physicians should be attentive to symptoms of infection or worsening of Still's disease, as these are known triggers for MAS.
Danish: Læger skal være opmærksomme på symptomer på infektion eller forværring af Stills sygdom, da dette kan udløse MAS.
English: Experience from individual patients who achieved a complete response following dose escalation to 600 mg (8 mg/kg) every 8 weeks suggests that a higher dose may be beneficial in patients not achieving complete response or not maintaining complete response with the recommended doses (150 mg or 2 mg/kg for patients ≥ 15 kg and ≤ 40 kg).
Danish: Erfaringer fra individuelle patienter, der opnåede et fuldt respons efter dosisøgning til 600 mg (8 mg/kg) hver 8. uge, antyder, at højere dosis kan være en fordel for patienter, der ikke opnår fuldt respons eller ikke vedligeholder fuldt respons med den anbefalede dosis (150 mg eller 2 mg/kg for patienter ≥15 kg og ≤40 kg).
English: In clinical studies, CAPS, TRAPS, HIDS/MKD and FMF patients who have uncontrolled overproduction of IL-1 beta show a rapid and sustained response to therapy with canakinumab, i.e. laboratory parameters such as high C-reactive protein (CRP) and serum amyloid A (SAA), high neutrophil and platelet counts, and leukocytosis rapidly returned to normal.
Danish: I kliniske studier udviste CAPS-, TRAPS-, HIDS/MKD- og FMF -patienter med ukontrolleret overproduktion af IL-1 beta et hurtigt og vedvarende respons på behandling med canakinumab, dvs. laboratorieparametre såsom højt C-reaktivt protein (CRP)-niveau og højt serumamyloid A (SAA)niveau, højt neutrofil- og trombocyttal, samt leukocytose normaliseredes hurtigt.