natgillin/translations-raw huggingface dataset:
Studie G2306 var et åbent studie som skulle vurdere vedligeholdelsen af behandlingsresponset med dosisreduktion af canakinumab (2 mg/kg hver 4. uge) eller forlængelse af dosisinterval (4 mg/kg hver 8. uge) hos SJIA-patienter, som fik canakinumab 4 mg/kg hver 4. uge.
Study G2306 was an open-label study to assess maintenance of treatment response with canakinumab dose reduction (2 mg/kg every 4 weeks) or dose interval prolongation (4 mg/kg every 8 weeks) in SJIA patients who were receiving canakinumab 4 mg/kg every 4 weeks.
Behandling af urinsyregigt Canakinumab bør ikke administreres under en aktiv infektion.
Canakinumab should not be administered during an active infection.
Forventede steady state eksponeringsværdier (Cmin,ss, Cmax,ss, AUC,ss,8w) efter 150 mg subkutan administration (eller 2 mg/kg respektivt) hver 8. uge var lidt højere i vægtkategorien 40-70 kg (6,6 µg/ml; 24,3 µg/ml; 767 µg∙dag/ml) sammenlignet med vægtkategorierne <40 kg (4,0 µg/ml; 19,9 µg/ml; 566 µg∙dag/ml) og >70 kg (4,6 µg/ml; 17,8 µg/ml; 545 µg∙dag/ml).
Predicted steady-state exposure values (Cmin,ss, Cmax,ss, AUC,ss,8w) after 150 mg subcutaneous administration (or 2 mg/kg, respectively) every 8 weeks were slightly higher in the weight category 40-70 kg (6.6 µg/ml, 24.3 µg/ml, 767 µg*d/ml) compared to the weight categories < 40 kg (4.0 µg/ml, 19.9 µg/ml, 566 µg*d/ml) and > 70 kg (4.6 µg/ml, 17.8 µg/ml, 545 µg*d/ml).
Tumornekrosefaktor-receptor-associeret periodisk syndrom (TRAPS) Ilaris er indiceret til behandling af tumornekrosefaktor (TNF)-receptor-associeret periodisk syndrom (TRAPS).
Tumour necrosis factor receptor associated periodic syndrome (TRAPS) Ilaris is indicated for the treatment of tumour necrosis factor (TNF) receptor associated periodic syndrome (TRAPS).
Et 56-ugers åbent studie blev udført for at undersøge canakinumab virkning, sikkerhed og tolerabilitet hos CAPS-patienter ≤ 4 år.
A 56-week, open-label study was conducted to assess the efficacy, safety and tolerability of canakinumab in paediatric CAPS patients ≤ 4 years of age.
En yderligere dosis på 150 mg kan overvejes
Additional dose of 150 mg can be considered
Et murint anti-murin IL-1 beta-antistof havde ingen uønskede virkninger på fertiliteten hos han- og hunmus (se pkt.
A murine antimurine IL-1 beta antibody had no undesirable effects on fertility in male or female mice (see section 5.3).
Primært endepunkt (sygdomsopblussen) - Andel af patienter, som havde ophør af opblussen af indekssygdom ved dag 15 og ikke havde en ny opblussen i resten af behandlingsperioden på 16 uger FMF
Primary endpoint (disease flare) - Proportion of patients who had index disease flare resolution at day 15 and did not experience a new flare during the remainder of the 16-week treatment period FMF
Det primære effektendepunkt i den randomiserede behandlingsperiode (del II) var andelen af respondenter i hver kohorte, som havde ophør af opblussen af deres indekssygdom ved dag 15 og ikke havde en ny opblussen i resten af behandlingsperioden på 16 uger (defineret som komplet respons).
The primary efficacy endpoint of the randomised treatment period (Part II) was the proportion of responders within each cohort who had resolution of their index disease flare at Day 15 and did not experience a new flare during the remainder of the 16-week treatment period (defined as complete response).
Før kanylen hele vejen ned i hætteglasset, indtil den når bunden.
Insert the needle all the way into the vial until it reaches the bottom edge.
Den maksimale koncentration af canakinumab i serum (Cmax) indtraf ca. 7 dage efter enkelt subkutan administration af 150 mg hos voksne CAPS-patienter.
The peak serum canakinumab concentration (Cmax) occurred approximately 7 days following single subcutaneous administration of 150 mg in adult CAPS patients.
MedDRAOrganklassesystem
MedDRA System Organ Class
80 pædiatriske CAPS-patienter (2-17 år) blev behandlet med canakinumab i interventionsstudierne.
There were 80 paediatric CAPS patients (2-17 years of age) who received canakinumab in the interventional studies.
Rygsmerter eller muskelsmerter.
Pain in the back or muscles.
Stills sygdom hos voksne og systemisk juvenil idiopatisk artritis er alvorlige autoinflammatoriske sygdomme, der skyldes den medfødte immunitet og udløses af pro-inflammatoriske cytokiner, hvor IL-1-beta er en væsentlig faktor.
Adult-onset Still's disease and systemic juvenile idiopathic arthritis are severe autoinflammatory diseases, driven by innate immunity by means of pro-inflammatory cytokines, a key one being IL-1beta.
9/l) og forbigående fald i antal blodplader blev observeret med en hyppigere forekomst med canakinumab (12,7 %) versus komparator (7,7 %) i de aktiv-kontrollerede kliniske studier hos urinsyregigt-patienter.
9/l) and transient decreases in platelet counts were observed at a higher incidence (12.7%) with canakinumab in the active-controlled clinical studies versus the comparator (7.7%) in gouty arthritis patients.
Læs hele denne vejledning igennem, inden du tager indsprøjtningen.
Read all the way through these instructions before injecting.
Opløsningen skal være klar til opaliserende og fri for synlige partikler.
The solution should be clear to opalescent and free of visible particles.
Dette omfatter kulderystelser, forkølelse, utilpashed, appetitløshed, smerter i kroppen, typisk i forbindelse med pludselig sygdom, ondt i halsen eller mundsår, hoste, slim, brystsmerter, vejrtrækningsproblemer, øresmerter, langvarig hovedpine eller lokal rødme, varme eller hævelse i huden eller betændelse i bindevæv (cellulitis).
These include shivering, chills, malaise, loss of appetite, body aches, typically in connection with a sudden onset of illness, sore throat or mouth ulcers, cough, phlegm, chest pain, difficulty breathing, ear pain, prolonged headache or localised redness, warmth or swelling of your skin or inflammation of connective tissue (cellulitis).
Studie G2305 var et randomiseret, dobbelblindet, placebokontrolleret studie på 4 uger, der vurderede korttidseffekten af canakinumab hos 84 patienter randomiseret til at få en enkelt dosis på 4 mg/kg (op til 300 mg) canakinumab eller placebo.
Study G2305 was a randomised, double-blind, placebo-controlled, 4-week study assessing the shortterm efficacy of canakinumab in 84 patients randomised to receive a single dose of 4 mg/kg (up to 300 mg) canakinumab or placebo.
Kontrollér, at der er 1,0 ml vand i sprøjten, og træk så kanylen ud af hætteglasset.
Make sure 1.0 ml of water is in the syringe, then take the needle out of the vial.
Fortsæt straks med indsprøjtningen.
Immediately proceed to administering the injection.
Brug af canakinumab samtidig med tumornekrosefaktor (TNF)-hæmmere frarådes, da dette kan øge risikoen for alvorlige infektioner (se pkt.
Concomitant use of canakinumab with tumour necrosis factor (TNF) inhibitors is not recommended because this may increase the risk of serious infections (see section 4.5).
Rens gummiproppen fra hætteglasset, der indeholder Ilaris-opløsningen, med en ny spritserviet.
Clean the rubber stopper of the vial containing the Ilaris solution with a new alcohol swab.
Canakinumab binder sig med høj affinitet specifikt til human IL-1 beta og neutraliserer human IL-1 betas biologiske aktivitet ved at blokere dets interaktion med IL-1-receptorer.
Canakinumab binds with high affinity specifically to human IL-1 beta and neutralises the biological activity of human IL-1 beta by blocking its interaction with IL-1 receptors, thereby preventing IL-1 beta-induced gene activation and the production of inflammatory mediators.
Ilaris' sikkerhed og virkning hos CAPS-, TRAPS-, HIDS/MKD- og FMF-patienter under 2 år er ikke klarlagt.
The safety and efficacy of Ilaris in CAPS, TRAPS, HIDS/MKD and FMF patients under 2 years of age have not been established.
Maksimal koncentration af canakinumab indtraf 2 til 7 dage (Tmax) efter en enkelt subkutan administration af canakinumab 150 mg eller 2 mg/kg hos pædiatriske patienter i alderen 4 år og derover.
Peak concentrations of canakinumab occurred between 2 to 7 days (Tmax) following single subcutaneous administration of canakinumab 150 mg or 2 mg/kg in paediatric patients 4 years of age and older.
*Angiver statistisk signifikans (1-sidet) ved 0,025-niveauet baseret på Fisher's exact test. **Angiver statistisk signifikans (1-sidet) ved 0,025-niveauet baseret på den logistiske regressionsmodel med henholdsvis behandlingsgruppe og baseline-PGA, -CRP eller -SAA som forklarende variabler for hver kohorte.
TRAPS n=number of responders; N=number of evaluable patients * indicates statistical significance (one-sided) at the 0.025 level based on Fisher exact test **Indicates statistical significance (one-sided) at the 0.025 level based on the logistic regression model with treatment group and baseline PGA, CRP or SAA respectively, as explanatory variables for each cohort
Samtidig brug af canakinumab og TNF-hæmmere frarådes, da dette kan øge risikoen for alvorlige infektioner.
Use of canakinumab with TNF inhibitors is not recommended because this may increase the risk of serious infections.
Ilaris anvendes til behandling af symptomer ved hyppige anfald af urinsyregigt hos voksne, som ikke har haft tilstrækkelig virkning af anden behandling.
Ilaris is used in adults to treat the symptoms of frequent gouty arthritis attacks if other treatments have not worked well enough.
Rekonstituér hvert canakinumabhætteglas under aseptiske forhold ved stuetemperatur (typisk 15°C til 25°C) ved langsomt at injicere 1 ml vand til injektionsvæsker med en 1 ml sprøjte og en 18 G x 2 tommer (50 mm) kanyle.
Using aseptic technique, reconstitute each vial of canakinumab at room temperature (typically 15°C to 25°C) by slowly injecting 1 ml water for injections with a 1 ml syringe and an 18 G x 2 inch (50 mm) needle.
Træk langsomt sprøjtestemplet op til det rigtige mærke (mængden skal svare til lægens instrukser), så sprøjten fyldes med Ilaris-opløsning.
Slowly pull the syringe plunger up to the correct mark (amount to be given as per healthcare provider's instructions), filling the syringe with Ilaris solution.
Hvis barnet reagerer godt på denne dosis, kan behandlingen fortsættes med en dosis på 8 mg/kg hver 8. uge.
If the child responds well enough to this, treatment may be continued with a dose of 8 mg/kg every 8 weeks.
Langtidsbehandling havde ingen indflydelse på bivirkningernes type eller frekvens.
No impact on the type or frequency of adverse drug reactions was seen with longer-term treatment.
4De fleste repræsenterede forbigående antydning til 1+ positiv urinprotein ved urinsticks.
3 Based on estimated creatinine clearance, most were transient 4 Most represented transient trace to 1+ positive urinary protein by dipstick 5 See further information below
Det skal du vide, før du begynder at tage Ilaris
What you need to know before you use Ilaris
• 150 mg til patienter med legemsvægt >40 kg
• 150 mg for patients with body weight > 40 kg
Ilaris indsprøjtes hver 8. uge som en enkelt dosis.
Ilaris is injected every 8 weeks as a single dose.
Tabel 3 Opsummering af effekt i fase III-studiets pivotale, randomiserede, placebokontrollerede behandlingsperiode (del II)
Table 3 Tabulated summary of efficacy in Phase III trial, pivotal, randomised, placebocontrolled treatment period (Part II)
Ilaris anvendes til voksne, unge og børn til behandling af aktiv Stills sygdom, herunder Stills sygdom hos voksne (AOSD) og systemisk juvenil idiopatisk artritis (SJIA) hos patienter på 2 år og derover, som ikke har haft tilstrækkelig virkning af anden behandling.
Ilaris is used in adults, adolescents and children to treat active Still's disease including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older if other treatments have not worked well enough.
Opløsningen skal være farveløs eller kan have et svagt brun-gult skær.
The solution should be colourless or may have a slight brownish-yellow tint.
Almindelig Muskuloskeletale smerter
Musculoskeletal pain Back pain
Ved CAPS, TRAPS, HIDS/MKD, FMF og Stills sygdom bør behandlingen indledes og superviseres af en speciallæge, der har erfaring med diagnosticering og behandling af den relevante sygdom.
For CAPS, TRAPS, HIDS/MKD, FMF and Still's disease, the treatment should be initiated and supervised by a specialist physician experienced in the diagnosis and treatment of the relevant indication.
Den forventede akkumuleringsratio var 1,3 gange efter 6 måneders subkutan administration af 150 mg canakinumab hver 8. uge.
The expected accumulation ratio was 1.3-fold following 6 months of subcutaneous administration of 150 mg canakinumab every 8 weeks.
Ilaris er indiceret til behandling af aktiv Stills sygdom, herunder Stills sygdom hos voksne (AOSD) og systemisk juvenil idiopatisk artritis (SJIA) hos patienter på 2 år og ældre, der har reageret utilstrækkeligt på tidligere behandling med non-steroide antiinflammatoriske stoffer (NSAID) og systemiske kortikosteroider.
Ilaris is indicated for the treatment of active Still's disease including adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older who have responded inadequately to previous therapy with non-steroidal anti-inflammatory drugs (NSAIDs) and systemic corticosteroids.
150 mg eller 2 mg/kg
150 mg or 2 mg/kg
Hyperimmunglobulin D-syndrom (HIDS)/mevalonatkinasemangel (MKD) Ilaris er indiceret til behandling af hyperimmunglobulin D-syndrom (HIDS)/mevalonat-kinase-mangel (MKD).
Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) Ilaris is indicated for the treatment of hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD).
- Tumornekrosefaktor-receptor-associeret periodisk syndrom (TRAPS) - Hyperimmunglobulin D-syndrom (HIDS) også kendt som mevalonat-kinase-mangel (MKD) - Familiær middelhavsfeber (FMF): Ilaris anvendes til behandling af FMF.
- Tumour necrosis factor receptor associated periodic syndrome (TRAPS) - Hyperimmunoglobulin D syndrome (HIDS) also known as mevalonate kinase deficiency (MKD) - Familial Mediterranean fever (FMF): Ilaris is used to treat FMF.
Hvis du har glemt at tage Ilaris
If you forget to use Ilaris
Patienter i urat-sænkende behandling (ULT)
Patients on urate lowering therapy (ULT)
Injektionsvæsken må ikke anvendes, hvis den indeholder tydeligt synlige partikler, er uklar eller er tydeligt brun.
Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Vedligeholdelsesdosis: 150 mg hver 4. uge
Maintenance dose: 150 mg every 4 weeks
Din læge vil tale med dig om de mulige risici, der er ved at tage Ilaris, før du begynder at amme.
Your doctor will discuss with you the potential risks of taking Ilaris before breast-feeding.
Den anbefalede dosis Ilaris til patienter med Stills sygdom (AOSD eller SJIA), der vejer 7,5 kg eller derover, er 4 mg/kg (op til højst 300 mg).
The recommended dose of Ilaris for patients with Still's disease (AOSD or SJIA) with body weight of 7.5 kg and above is 4 mg/kg (up to a maximum of 300 mg).
Neonatalt multisystemisk inflammatorisk sygdom (NOMID)/kronisk infantilt neurologisk hudog ledsyndrom (CINCA),
• Neonatal-onset multisystem inflammatory disease (NOMID) / chronic infantile neurological,
Den forventede akkumulationsratio var 1,1 gange efter subkutan administration af 150 mg canakinumab hver 12. uge.
The expected accumulation ratio was 1.1-fold following subcutaneous administration of 150 mg canakinumab every 12 weeks.
Alle patienter skal informeres om at søge læge, hvis tegn eller symptomer, der tyder på tuberkulose (fx vedvarende hoste, vægttab, let feber) opstår under behandling med canakinumab.
All patients should be instructed to seek medical advice if signs or symptoms suggestive of tuberculosis (e.g. persistent cough, weight loss, subfebrile temperature) appear during canakinumab therapy.
Ilaris anvendes til behandling af følgende inflammatoriske sygdomme (betændelseslignende tilstande): - Periodiske febersyndromer:
What Ilaris is used for Ilaris is used for treatment of the following inflammatory diseases: - Periodic fever syndromes:
Smerter i den øvre del af abdomen
Upper abdominal pain.
• 150 mg til patienter, som vejer over 40 kg
• 150 mg for patients who weigh more than 40 kg
Canakinumab skal administreres så hurtigt som muligt efter frembrud af et urinsyregigt-anfald for at få maksimal virkning.
For maximum effect, canakinumab should be administered as soon as possible after the onset of a gouty arthritis attack.
Hold sprøjten vinkelret på huden, og skub med en enkelt, jævn bevægelse kanylen lige ned og helt ind i huden.
Hold the syringe at a 90-degree angle and in a single, smooth motion, push the needle straight down completely into the skin.
Pakningen indeholder ikke et hætteglas (eller ampul) med sterilt vand til injektionsvæsker (”vand”) (opbevares ved stuetemperatur) en 1,0 ml sprøjte en 18 G x 2 tommer (50 mm) kanyle til opløsning af pulveret (”overførselskanyle”) en 27 G x 0,5 tommer (13 mm) kanyle til indsprøjtning (”indsprøjtningskanyle”) spritservietter rene, tørre bomuldsservietter et hæfteplaster en passende affaldsbeholder til brugte kanyler, sprøjte og hætteglas (kanyleboks)
Not included in the pack one vial (or ampoule) of sterile water for injections (“water”) (at room temperature) one 1.0 ml syringe one 18 G x 2 inch (50 mm) needle for reconstituting the powder (“transfer needle”) one 27 G x 0.5 inch (13 mm) needle for injecting (“injection needle”) alcohol swabs clean, dry cotton swabs an adhesive plaster a proper disposal container for used needles, syringe and vials (sharps container)
Biotilgængeligheden er ikke blevet bestemt specifikt hos SJIA-patienter.
Bioavailability in SJIA patients has not been determined independently.
Hvis du ikke reagerer godt nok på den anden dosis, kan en tredje dosis Ilaris på 300 mg eller 4 mg/kg gives.
If you do not respond well enough to the second dose, a third dose of Ilaris at 300 mg or 4 mg/kg may be given.
Ilaris indeholder Aktivt stof: canakinumab.
The active substance is canakinumab.
Stills sygdom hos voksne (AOSD) og systemisk juvenil idiopatisk artritis (SJIA)
- Still's disease including adult onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis (SJIA) - Gouty arthritis
Laboratorieabnormiteter hos TRAPS-, HIDS/MKD- og FMF-patienter Neutrofiler
Laboratory abnormalities in TRAPS, HIDS/MKD and FMF patients Neutrophils
Udseende og pakningsstørrelser - Ilaris leveres som et pulver til injektionsvæske, opløsning (150 mg i et 6 ml hætteglas).
What Ilaris looks like and contents of the pack Ilaris is supplied as a powder for solution for injection (150 mg in a 6 ml glass vial).
CAPS, TRAPS, HIDS/MKD, FMF eller Stills sygdom (AOSD eller SJIA): Du skal fortsætte med at tage Ilaris, så længe lægen fortæller dig, at du skal.
CAPS, TRAPS, HIDS/MKD, FMF or Still's disease (AOSD or SJIA): You should continue using Ilaris for as long as the doctor tells you.
Den gennemsnitlige eksponerning hos en typisk urinsyregigtpatient (93 kg) efter en enkel subkutan 150 mg dosis (Cmax: 10,8 µg/ml og AUCinf: 495 µg*dag/ml) var lavere end hos en typisk 70 kg CAPS-patient (15,9 µg/ml og 708 µg*dag/ml).
Mean exposure in a typical gouty arthritis patient (93 kg) after a single subcutaneous 150 mg dose (Cmax: 10.8 µg/ml and AUCinf: 495 µg*d/ml) was lower than in a typical 70 kg CAPS patient (15.9 µg/ml and 708 µg*d/ml).
Eventuelle medicinrester skal kasseres efter, at lægemidlet er blevet indsprøjtet.
- Any unused medicine must be discarded after the dose has been injected.
Træk langsomt sprøjtestemplet op til det rigtige mærke (den mængde, der skal gives), så sprøjten fyldes med Ilaris-injektionsvæske.
Slowly pull the syringe plunger up to the correct mark (amount to be given), filling the syringe with Ilaris solution.
Læg sprøjten til side.
Set the syringe aside.
102 patienter med TRAPS, HIDS/MKD eller FMF (i alderen 2-17 år) fik canakinumab i et studie af 16 ugers varighed.
There were 102 TRAPS, HIDS/MKD and FMF patients (2-17 years of age) who received canakinumab in a 16-week study.
Hvis injektionsvæsken ikke anvendes straks, skal den opbevares i køleskab (2 C - 8 C) og anvendes indenfor 24 timer.
If not used immediately, the solution should be stored in the refrigerator (2°C - 8°C) and used within 24 hours.
Tumornekrosefaktor-receptor-associerede periodiske syndromer (TRAPS), hyperimmunglobulin Dsyndrom (HIDS)/mevalonat-kinase-mangel (MKD) og familiær middelhavsfeber (FMF) Den anbefalede startdosis er: Voksne og børn på 2 år og derover
Tumour necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) and familial Mediterranean fever (FMF) The recommended starting dose of Ilaris is: - Adults and children aged 2 years or more
Baseret på en populationsfarmakokinetisk modelleringsanalyse var canakinumabs farmakokinetik hos børn i alderen 2 til <4 år lig den hos patienter i alderen 4 år og ældre.
Based on the population pharmacokinetic modelling analysis, the pharmacokinetics of canakinumab in children aged 2 to < 4 years were similar to those in patients 4 years of age and older.
Undgå at berøre kanylerne og toppen af hætteglassene.
Avoid touching the needles and the tops of the vials.
Overordnet var der ingen klinisk relevant forskel mellem sikkerheds- og tolerabilitetsprofilen for canakinumab hos pædiatriske patienter sammenlignet med den samlede population.
Overall, there were no clinically meaningful differences in the safety and tolerability profile of canakinumab in paediatric patients compared to the overall population.
Vend hætteglas og sprøjte på hovedet, og hold dem op i øjenhøjde.
Turn the vial and syringe upside down and bring to eye level.
Effekten og sikkerheden af canakinumab hos unge SJIA-patienter i alderen 16 til 20 år var i overensstemmelse med effekten og sikkerheden observeret hos patienter under 16 år.
Efficacy and safety of canakinumab in young adult SJIA patients aged 16 to 20 years were consistent with the efficacy and safety observed for patients less than 16 years of age.
Hvis du kan se bobler i sprøjten, skal du fjerne boblerne som anvist af lægen, sygeplejersken eller apoteket.
If you see bubbles in the syringe, remove bubbles as instructed by your healthcare professional or pharmacist.
• Systemisk inflammatorisk sygdom med neonatal debut (NOMID) også kaldet kronisk infantil neurologisk hud- og ledsyndrom (CINCA),
• Neonatal-onset multisystem inflammatory disease (NOMID), also called chronic infantile neurological, cutaneous, articular syndrome (CINCA),
Fjern hætten fra hætteglasset med Ilaris og hætteglasset med vand.
Remove the caps from the Ilaris and water vials.
Den er farveløs til svagt brunlig-gul.
It is colourless to slightly brownish-yellow.
Blanding af Ilaris
Mixing Ilaris
- Del III: Patienter, der gennemførte 16 ugers behandling og blev klassificeret som respondenter, blev randomiseret igen til en dobbeltblind seponeringsperiode på 24 uger, hvor de fik canakinumab 150 mg (2 mg/kg for patienter ≤40 kg) s.c. eller placebo hver 8. uge.
- Part III: Patients who completed 16 weeks of treatment and were classified as responders were re-randomised into a 24-week, double-blind withdrawal period during which they received canakinumab 150 mg (2 mg/kg for patients ≤ 40 kg) s.c. or placebo every 8 weeks.
Vælg et indsprøjtningssted på det øverste af låret, maven, overarmen eller balden.
Choose an injection site on the upper thigh, abdomen, upper arm or buttocks.
• Hyperimmunglobulin D-syndrom (HIDS)/mevalonatkinase-mangel (MKD),
• Hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD),
Hvis du har CAPS, TRAPS, HIDS/MKD, FMF eller Stills sygdom (AOSD eller SJIA) og har glemt at indsprøjte en dosis Ilaris, skal du tage den næste indsprøjtning, så snart du kommer i tanke om det.
If you have CAPS, TRAPS, HIDS/MKD, FMF or Still's disease (AOSD or SJIA) and have forgotten to inject a dose of Ilaris, inject the next dose as soon as you remember.