natgillin/translations-raw huggingface dataset:
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.
Canakinumab er et humant monoklonalt anti-human interleukin-1 beta (IL-1 beta)-antistof af IgG1/κisotypen. 
Canakinumab is a human monoclonal anti-human interleukin-1 beta (IL-1 beta) antibody of the IgG1/κ isotype.
Sikkerhedsprofilen for canakinumab var den samme som hos patienterne på 2 år og derover. 
The safety profile of canakinumab appeared similar to that in patients aged 2 years and above.
CAPS-interventionsstudierne med canakinumab omfattede i alt 80 pædiatriske patienter i alderen 2 til 17 år (ca. halvdelen af dem behandlet ud fra mg/kg). 
The CAPS interventional trials with canakinumab included a total of 80 paediatric patients with an age range from 2 to 17 years (approximately half of them treated on an mg/kg basis).
Udtag omhyggeligt det nødvendige volumen, afhængig af hvilken dosis der skal administreres (0,1 ml til 1 ml), og injicér subkutant med en 27 G x 0,5 tomme (13 mm) kanyle. 
Carefully withdraw the required volume depending on the dose to be administered (0.1 ml to 1 ml) and subcutaneously inject using a 27 G x 0.5 inch (13 mm) needle.
Hvis det bløder, kan du lægge en ren, tør bomuldsserviet over området og trykke blidt i 1 til 2 minutter, eller indtil blødningen holder op. Sæt derefter hæfteplaster på. 
If bleeding occurs, apply a clean, dry cotton swab over the area, and press gently for 1 to 2 minutes, or until bleeding stops.
En type af medicin, der kaldes tumor-nekrose faktor (TNF)-hæmmere fx etanercept, adalimumab eller infliximab. 
Medicines called tumour necrosis factor (TNF) inhibitors, such as etanercept, adalimumab or infliximab.
Kvinder, som har været i behandling med canakinumab under graviditet, skal informeres om at oplyse dette til barnets sundhedsperson, før eventuelle vacciner gives til det nyfødte spædbarn. 
Women who received canakinumab during pregnancy should be instructed to inform the baby's healthcare professional before any vaccinations are given to their newborn infant.
Ekspression af hepatiske CYP-enzymer kan undertrykkes af de cytokiner, der stimulerer kronisk inflammation, som fx interleukin-1 beta (IL-1 beta). 
The expression of hepatic CYP450 enzymes may be suppressed by the cytokines that stimulate chronic inflammation, such as interleukin-1 beta (IL-1 beta).
Den overordnede forventede median (±SD) for Cmin,ss, Cmax,ss og AUC,ss4w var henholdsvis 14,7±8,8 μg/ml, 36,5 ± 14,9 μg/ml og 696,1 ± 326,5 μg*dag/ml. 
The overall predicted mean (±SD) for Cmin,ss, Cmax,ss and AUC,ss4w were 14.7±8.8 μg/ml, 36.5 ± 14.9 μg/ml and 696.1 ± 326.5 μg*d/ml, respectively.
Smerter i leddene (artralgi). 
Pain in joints (arthralgia).
Almindelige tegn på AOSD og SJIA inkluderer feber, udslæt, hepatosplenomegali, lymfadenopati, polyserositis og artritis. 
Common features of AOSD and SJIA include fever, rash, hepatosplenomegaly, lymphadenopathy, polyserositis and arthritis.
Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Ilaris i alle undergrupper af den pædiatriske population med urinsyregigt (se pkt. 
The European Medicines Agency has waived the obligation to submit the results of studies with Ilaris in all subsets of the paediatric population in gouty arthritis (see section 4.2 for information on paediatric use).
Du må ikke anvende denne medicin, hvis du bemærker, at injektionsvæsken ikke er klar til opaliserende, eller hvis den indeholder partikler. 
- Do not use this medicine if you notice that the solution is not clear to opalescent or contains particles.
Den anden patient fik en startdosis på 2 mg/kg canakinumab og en tillægsdosis på 2 mg/kg ved uge 3 og blev optitreret i uge 5 til at få en dosis på 4 mg/kg administreret hver 4. uge indtil afslutning af studiets del II. 
The second patient received a starting dose of canakinumab 2 mg/kg and an add-on dose of 2 mg/kg at week 3, and was up-titrated at week 5 to receive a dose of 4 mg/kg administered every 4 weeks until the end of Part II of the study.
Virkningen af canakinumab til behandling af akutte anfald af urinsyregigt blev påvist i to multicenter, randomiserede, dobbelt-blindede, aktiv-kontrollerede studier med patienter med hyppige anfald af urinsyregigt (≥3 anfald i de sidste 12 måneder), der ikke kunne anvende NSAID eller colchicin (på grund af kontraindikation, intolerance eller manglende virkning). 
The efficacy of canakinumab for the treatment of acute gouty arthritis attacks was demonstrated in two multicentre, randomised, double-blind, active-controlled studies in patients with frequent gouty arthritis (≥ 3 attacks in the previous 12 months) unable to use NSAIDs or colchicine (due to contraindication, intolerance or lack of efficacy).
I det samlede SJIA-program blev forbigående fald i antal hvide blodlegemer (WBC) til ≤0,8 x LLN indberettet hos 33 patienter (16,5 %). 
In the overall SJIA programme, transient decreased white blood cell (WBC) counts ≤ 0.8 x LLN were reported in 33 patients (16.5%).
I del I (open label) var 177 patienter inkluderet, som fik 4 mg/kg (op til 300 mg) canakinumab administreret hver 4. uge i op til 32 uger. 
In Part I (open label) 177 patients were enrolled and received 4 mg/kg (up to 300 mg) canakinumab administered every 4 weeks for up to 32 weeks.
Reaktioner på indsprøjtningsstedet (fx rødme, hævelse, varme og kløe). 
Injection site reaction (such as redness, swelling, warmth and itching).