natgillin/translations-raw huggingface dataset:
De hyppigste bivirkninger var infektioner, hovedsageligt i øvre luftveje.
The most frequent adverse drug reactions were infections predominantly of the upper respiratory tract.
Denne dosis administreres hver ottende uge som en enkelt dosis via subkutan injektion.
This is administered every eight weeks as a single dose via subcutaneous injection.
6.6 for anvisninger i rekonstruktion af lægemidlet før administration.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Instruktioner vedrørende administration
Instructions for administration
Asymptomatisk, let forhøjelse af bilirubin i serum er observeret hos CAPS-patienter, der blev behandlet med canakinumab, uden samtidig forhøjelse af niveauet af transaminaser.
Asymptomatic and mild elevations of serum bilirubin have been observed in CAPS patients treated with canakinumab without concomitant elevations of transaminases.
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.
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.
- Ilaris fås i pakninger med ét hætteglas eller multipakninger bestående af fire delpakninger, der hver indeholder et hætteglas.
Ilaris is available in packs containing one vial or multipacks comprising four intermediate packs, each containing one vial.
Kryopyrin-associerede periodiske syndromer
Cryopyrin-associated periodic syndromes
Canakinumabs tilsyneladende clearance (CL/F) stiger med stigende legemsvægt.
The apparent clearance (CL/F) of canakinumab increases with body weight.
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).
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).
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.
Your doctor may want to check your vaccination history and give you any vaccinations that you have missed before you start treatment with Ilaris.
Sving langsomt hætteglasset rundt (det må ikke rystes), uden at berøre gummiproppen, i en vinkel på omkring 45 grader i ca. 1 minut.
Without touching the rubber stopper, swirl (do not shake) the vial slowly at an angle of about 45 degrees for about 1 minute.
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:
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:
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.
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.
Studie G2301 var et randomiseret, dobbelblindet, placebokontrolleret seponeringsstudie til forebyggelse af udbrud med canakinumab.
Study G2301 was a randomised, double-blind, placebo-controlled withdrawal study of flare prevention by canakinumab.
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.
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.
Ilaris indeholder det aktive stof canakinumab, et monoklonalt antistof, der tilhører en lægemiddelgruppe, der hedder interleukinhæmmere.
Ilaris contains the active substance canakinumab, a monoclonal antibody that belongs to a group of medicines called interleukin inhibitors.
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).
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).
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.
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.
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.
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.
Din læge vil overvåge dig for mulige faktorer, der kan udløse MAS, fx infektioner og reaktivering af Stills sygdom (udbrud).
Your doctor will monitor you for potential triggering factors of MAS that include infections and re-activation of the underlying Still's disease (flare).
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.
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).
Tuberkulosescreening
Tuberculosis screening
Der må ikke sprøjtes luft ned i væsken.
Do not inject air into the liquid.
Triglycerider
Triglycerides
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.
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.
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.
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.
Det kan dog ikke udelukkes, at der er risiko for alvorlige overfølsomhedsreaktioner, hvilket ikke er ualmindeligt for injicerbare proteiner (se pkt.
However, the risk of severe hypersensitivity reactions, which is not uncommon for injectable proteins, cannot be excluded (see section 4.3).
Rens indsprøjtningsstedet med en ny spritserviet.
Clean the injection site with a new alcohol swab.
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.
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.
Hyperurikæmi bør håndteres med påbegyndelse eller optimering af passende urat-sænkende behandling (ULT).
Management of hyperuricaemia with appropriate urate lowering therapy (ULT) should be instituted or optimised.
Nedsat antal hvide blodlegemer (leukopeni).
Drop in level of white blood cells (leukopenia).
Der findes ingen tilgængelige data vedrørende effekten af levende vacciner eller sekundær overførsel af infektioner via levende vacciner hos patienter, der får canakinumab.
No data are available on either the effects of live vaccination or the secondary transmission of infection by live vaccines in patients receiving canakinumab.
Find et rent sted, hvor du kan forberede og foretage indsprøjtningen.
Find a clean place in which to prepare and administer the injection.
Ilaris er ikke undersøgt hos patienter med nedsat leverfunktion.
Ilaris has not been studied in patients with hepatic impairment.
Der er ikke foretaget formelle karcinogenicitetsstudier med canakinumab.
Formal carcinogenicity studies have not been conducted with canakinumab.
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.
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.
Et 6 års observationelt registerstudie blev gennemført for at generere data for langtidssikkerhed ogeffektivitet for pædiatriske og voksne CAPS patienter i rutine klinisk praksis.
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.
I et andet studie blev der ikke observeret stigning i urinsyre blandt patienter, som startede på ULT.
In another study, among patients who were starting on ULT, increases in uric acid were not observed.
Læger skal være opmærksomme på symptomer på infektion eller forværring af Stills sygdom, da dette kan udløse MAS.
Physicians should be attentive to symptoms of infection or worsening of Still's disease, as these are known triggers for MAS.
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).
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).
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.
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.
Ilaris' sikkerhed og virkning hos SJIA-patienter under 2 år er ikke klarlagt.
The safety and efficacy of Ilaris in SJIA patients under 2 years of age have not been established.
Der er ingen tilgængelige data om risikoen for sekundær overførsel af infektion fra levende (svækkede) vacciner hos patienter, der får canakinumab.
No data are available on the risk of secondary transmission of infection by live (attenuated) vaccines in patients receiving canakinumab.
Selvom der forekom reduktion i trombocyttallet (≥grad 2) hos 0,6 % af patienterne, er blødning ikke blevet identificeret som en bivirkning.
Although reductions in platelet count (≥ Grade 2) occurred in 0.6% of patients, bleeding has not been identified as an adverse reaction.
Unormale prøveresultater for nyrefunktionen (nedsat kreatininclearance, proteinuri).
Abnormal kidney function test results (creatinine renal clearance decreased, proteinuria).
Ilaris kan gives som monoterapi eller i kombination med methotrexat.
Ilaris can be given as monotherapy or in combination with methotrexate.
Dette kan forårsage feber, hovedpine, træthed, hududslæt eller led- og muskelsmerter.
This may cause fever, headache, fatigue, skin rash, or painful joints and muscles.
*humant monoklonalt antistof fremstillet i Sp2/0-myelomceller fra mus ved rekombinant DNAteknologi
* human monoclonal antibody produced in mouse myeloma Sp2/0 cells by recombinant DNA technology
Behandling med canakinumab resulterede i en hurtig og vedvarende bedring af både artikulære og systemiske tegn på SJIA med signifikant reduktion af antallet af betændte led, hurtig normalisering af temperatur og reduktion af akutfasereaktanter hos størstedelen af patienterne (se ”Klinisk virkning og sikkerhed”).
Treatment with canakinumab resulted in a rapid and sustained improvement of both the articular and the systemic features of SJIA with significant reduction of the number of inflamed joints, prompt resolution of fever and reduction of acute phase reactants in the majority of patients (see Clinical efficacy and safety).
Ved TRAPS, HIDS/MKD og FMF var eksponeringsparametrene (laveste koncentration) sammenlignelige på tværs af aldersgrupper fra 2 til <20 år efter subkutan administration af canakinumab 2 mg/kg hver 4. uge.
In TRAPS, HIDS/MKD and FMF, exposure parameters (trough concentrations) were comparable across age groups from 2 to < 20 years old following subcutaneous administration of canakinumab 2 mg/kg every 4 weeks.
Forekomsten af patienter med triglycerid-stigning >5x øvre normalgrænse (ULN) var 2,4 % med canakinumab og 0,7 % med triamcinolonacetonid.
The incidence of patients with triglyceride elevations > 5 x upper limit of normal (ULN) was 2.4% with canakinumab and 0.7% with triamcinolone acetonide.
Lad være med at gnide på indsprøjtningsstedet.
Do not rub the injection area.
Langtidsdata og laboratorieanomalier hos CAPS-patienter I kliniske studier med canakinumab hos CAPS-patienter steg middelværdierne for hæmoglobin, og middelværdierne for hvide blodlegemer, neutrofile og blodplader faldt.
Long-term data and laboratory abnormalities in CAPS patients During clinical trials with canakinumab in CAPS patients mean values for haemoglobin increased and those for white blood cell, neutrophils and platelets decreased.
Der blev ikke set en tydelig sammenhæng mellem udvikling af antistoffer og klinisk respons eller bivirkninger.
No apparent correlation of antibody development to clinical response or adverse events was observed.
I det samlede SJIA-program blev forhøjet ALAT og/eller ASAT >3 x øvre normalgrænse (ULN) indberettet hos 19 patienter (9,5 %).
In the overall SJIA programme, high ALT and/or AST > 3 x upper limit of normal (ULN) were reported in 19 patients (9.5%).
Må ikke anvendes, hvis der er partikler i opløsningen.
Do not use if particles are present in the solution.
Der blev indberettet statistisk signifikante forbedringer i Child Health spørgeskema PF50-score for canakinumab versus placebo i studie G2305 (fysisk p=0,0012; psykologisk trivsel p=0,0017).
Statistically significant improvements in the Child Health Questionnaire-PF50 scores were reported for canakinumab vs placebo in study G2305 (physical p=0.0012; psychosocial well-being p=0.0017).
Sørg for, at vandet dækker overførselskanylens spids, og træk langsomt sprøjtestemplet tilbage og en anelse forbi 1,0 ml-mærket.
Make sure the tip of the transfer needle is covered by the water and slowly pull the syringe plunger down to slightly past the 1.0 ml mark.
Tabel 1 Tabel over bivirkninger
Table 1 Tabulated list of adverse reactions
Effektresultaterne i en undergruppe af patienter, der var ude af stand til at anvende både NSAID og colchicin, og som var på ULT, eller hvor ULT var mislykkedes, eller som havde kontraindikationer mod ULT (N=101), var i overensstemmelse med den totale studiepopulation med en statistisk signifikant forskel versus triamcinolonacetonid i smerteintensitet ved 72 timer (-10,2 mm, p=0,0208) og i reduktion af risiko for efterfølgende anfald (hazard ratio 0,39; p=0,0047 ved 24 uger).
Efficacy results in a subgroup of patients unable to use both NSAIDs and colchicine and who were on ULT, failed ULT or had a contraindication to ULT (N=101) were consistent with the overall study population with a statistically significant difference compared to triamcinolone acetonide in pain intensity at 72 hours (-10.2 mm, p=0.0208) and in reduction of risk of subsequent attacks (Hazard ratio 0.39, p=0.0047 at 24 weeks).
TRAPS, HIDS/MKD og FMF Canakinumab's effekt og sikkerhed ved behandling af TRAPS, HIDS/MKD og FMF blev påvist i et enkelt firdelt pivotalt fase III-studie (N2301), der omfattede tre særskilte sygdomskohorter.
TRAPS, HIDS/MKD and FMF The efficacy and safety of canakinumab for the treatment of TRAPS, HIDS/MKD and FMF were demonstrated in a single, pivotal, phase III, 4-part study (N2301) consisting of three separate disease cohorts.
Ilaris bør gives i kombination med colchicin, såfremt dette er hensigtsmæssigt.
Ilaris should be given in combination with colchicine, if appropriate.
Makrofag-aktiveringssyndrom hos patienter med Stills sygdom
Macrophage activation syndrome in patients with Still's disease
Efter gentagen subkutan administration af 150 mg hver 4. uge blev minimumkoncentrationen (Cmin) af canakinumab ved uge 16 estimeret til at være 15,4 ± 6,6 g/ml.
After repeated subcutaneous administration of 150 mg every 4 weeks, canakinumab minimal concentration at week 16 (Cmin) was estimated to be 15.4 ± 6.6 g/ml.
Behandling med canakinumab forbedrede alle pædiatriske ACR-responsscorer sammenlignet med placebo på dag 15 og 29 (Tabel 4).
Canakinumab treatment improved all paediatric ACR response scores as compared to placebo at days 15 and 29 (Table 4).
Stills sygdom, herunder AOSD og SJIA, er en inflammatorisk (betændelseslignende) sygdom, der forårsager smerte, hævelse og inflammation i et eller flere led, samt udslæt og feber.
Still's disease including AOSD and SJIA is an inflammatory disease that can cause pain, swelling and inflammation of one or more joints, as well as rash and fever.
CAPS hos voksne og børn ≥4 år ≥15 kg
CAPS in adults and children  4 years of age  15 kg
Det anbefales ikke at administrere levende vacciner til nyfødte spædbørn, som har været eksponeret for canakunimab in utero, de første 16 uger efter moderens sidste dosis af canakinumab før fødslen.
However, administration of live vaccines to newborn infants exposed to canakinumab in utero is not recommended for 16 weeks following the mother's last dose of canakinumab before childbirth.
Kontrollér udløbsdatoen på hætteglasset og sprøjterne.
Check the expiry dates on the vial and syringes.
I dette studie reducerede 25 patienter, der havde højt ACR-respons i mindst 5 måneder, deres canakinumab-dosis til 2 mg/kg hver 4. uge og opretholdt et pædiatrisk ACR100-respons i hele den periode, hvor den reducerede dosis blev givet (median 32 uger, 8-124 uger).
In this study, 25 patients who had a strong ACR response for a minimum of 5 months reduced their canakinumab dose to 2 mg/kg every 4 weeks and maintained a paediatric ACR100 response throughout the time the reduced dose was given (median 32 weeks, 8-124 weeks).
Hyppigheden af bivirkninger hos begge behandlingsarme var sammenlignelig med hyppigheden set hos patienter behandlet med canakinumab 4 mg/kg hver 4. uge.
The rate of adverse events in both treatment arms was similar to the rate seen in patients treated with canakinumab 4 mg/kg every 4 weeks.
Den mediane ændring i smertescore (0-100 mm visuel analog skala) på dag 15 var -50,0 mm for canakinumab (N=43) sammenlignet med +4,5 mm for placebo (N=25).
The mean change in patient pain score (0-100 mm visual analogue scale) at day 15 was -50.0 mm for canakinumab (N=43), as compared to +4.5 mm for placebo (N=25).
Forhøjet urinsyre blev ikke observeret i kliniske studier hos populationer, der ikke havde urinsyregigt (se pkt.
Uric acid increases were not observed in clinical trials in non-gouty arthritis populations (see section 5.1).
Fortsat behandling med canakinumab hos patienter uden klinisk bedring skal revurderes af den behandlende læge.
Continued treatment with canakinumab in patients without clinical improvement should be reconsidered by the treating physician.
Ilaris kan anvendes sammen med colchicin, hvis det er relevant.
Ilaris can be used together with colchicine, if appropriate.
Unormale resultater af blodprøver for leverfunktionen (forhøjede aminotransferaser) eller højt indhold af galdefarvestof i blodet, med eller uden gulfarvning af hud og øjne (hyperbilirubinæmi).
Abnormal liver function test results (transaminases increased) or high level of bilirubin in the blood, with or without yellow skin and eyes (hyperbilirubinaemia).
I aktiv-kontrollerede studier med urinsyregigt var der en gennemsnitlig stigning i triglycerider på 33,5 mg/dl hos canakinumab-behandlede patienter sammenlignet med en beskedent fald på -3,1 mg/dl ved triamcinolonacetonid.
In active-controlled gouty arthritis trials, there was a mean increase in triglycerides of 33.5 mg/dl in canakinumab-treated patients compared with a modest decrease of -3.1 mg/dl with triamcinolone acetonide.
Urinsyregigt: Hvis du har et anfald af urinsyregigt, vil du få en enkelt dosis Ilaris.
Gouty arthritis: If you have a gouty arthritis attack, you will be given a single dose of Ilaris.
Giv slip på huden, og træk kanylen lige ud.
Release the pinched skin and pull the needle straight out.
Patienter, der tog canakinumab i del II, havde 64 % reduceret risiko for udbrud sammenlignet med placebogruppen (hazard ratio 0,36; 95 % konfidensinterval: 0,17 til 0,75; p=0,0032).
Patients taking canakinumab in Part II had a 64% reduced risk of a flare event as compared to the placebo group (hazard ratio of 0.36; 95% CI: 0.17 to 0.75; p=0.0032).
Ikke i stand til at bruge hverken NSAID eller colchicin; på ULT N=62 Behandling af urinsyregigt-anfald målt på smerteintensitet (VAS) ved 72 timer Forskel fra triamcinolonacetonid estimeret ved mindste kvadraters metode CI p-værdi, 1-sidet p < 0,0001*
Unable to use both NSAIDs and colchicine; on ULT N=62 Treatment of gouty arthritis attacks as measured by pain intensity (VAS) at 72 h Least Squares mean estimated difference to triamcinolone acetonide CI p-value, 1-sided p < 0.0001*
Efter 24 uger var 71 % (27/38) af patienterne, som fik reduceret dosis (2 mg/kg hver 4. uge), og 84 % (31/37) af patienterne som fik forlænget dosisinterval (4 mg/kg hver 8. uge) i stand til at opretholde inaktiv sygdomsstatus i 6 måneder.
After 24 weeks, 71% (27/38) of patients who received the reduced dose (2 mg/kg every 4 weeks) and 84% (31/37) of patients who received the prolonged dosing interval (4 mg/kg every 8 weeks) were able to maintain inactive disease status for 6 months.
Samlet kunne 33 % (25/75) af patienterne, randomiseret til armene dosisreduktion eller forlængelse af dosisinterval, seponere behandlingen med canakinumab og opretholde inaktiv sygdomsstatus i 6 måneder.
Overall, 33% (25/75) of patients randomised to dose reduction or dose interval prolongation arms were able to discontinue treatment with canakinumab and maintain inactive disease status for 6 months.