natgillin/translations-raw huggingface dataset:
Den absolutte biotilgængelighed af subkutant administreret canakinumab blev vurderet til 66 %. 
The absolute bioavailability of subcutaneously administered canakinumab was estimated to be 66%.
C-reaktivt protein ≤10 mg/l 
C-reactive protein ≤ 10 mg/l
Behandling med canakinumab resulterede i klinisk relevant forbedring i patienternes fysiske funktion og livskvalitet. 
Treatment with canakinumab resulted in clinically relevant improvements in patients' physical function and quality of life.
• Muckle-Wells syndrom (MWS), 
• Muckle-Wells syndrome (MWS),
Der blev ikke observeret nogen forskel i sikkerhed eller virkning hos patienter under 2 år sammenlignet med patienter på 2 år og derover. 
No differences in safety or efficacy were observed in patients under the age of 2 years compared with patients aged 2 years and above.
Der foreligger ingen humane data, men da canakinumab er et klasse G-immunglobulin (IgG1), forventes human transplancental overførsel. 
No human data are available, but as canakinumab is an immunoglobulin of the G class (IgG1), human transplacental transfer is expected.
Den kliniske erfaring hos CAPS-patienter uden en bekræftet mutation i NLRP3-genet er begrænset. 
Clinical experience in CAPS patients without a confirmed mutation in the NLRP3 gene is limited.
Risikoen for udvikling af malignitet ved anti-interleukin (IL)-1-behandling er ukendt. 
The risk for the development of malignancies with anti-interleukin (IL)-1 therapy is unknown.
Af de patienter, der blev behandlet med 600 mg eller 8 mg/kg (eller højere), opnåede 43,8 % fuldt respons. 
Of the patients treated with 600 mg or 8 mg/kg (or even higher), 43.8% achieved complete response.
Find et rent sted, hvor du kan forberede og give dig selv indsprøjtningen. 
Find a clean place in which to prepare and give yourself the injection.
Kvinder bør anvende effektiv prævention under behandling med canakinumab og i op til 3 måneder efter den sidste dosis. 
Women should use effective contraceptives during treatment with canakinumab and for up to 3 months after the last dose.
Studiet undersøgte også canakinumabs indflydelse på udvikling af antistoffer på standard børnevacciner. 
The study also evaluated the effect of canakinumab on the development of antibodies to standard childhood vaccines.
Hvis du har urinsyregigt, vil din behandling blive overvåget af en læge med specialviden. 
If you have gouty arthritis, your treatment will be overseen by a doctor with specialist training.
Farmakoterapeutisk klassifikation: Immunsuppressiva, interleukinhæmmere, ATC-kode: L04AC08 
Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC08
Tag ikke Ilaris hvis du er allergisk over for canakinumab eller et af de øvrige indholdsstoffer (angivet i punkt 6). 
Do not use Ilaris - if you are allergic to canakinumab or any of the other ingredients of this medicine (listed in section 6).
Under den kliniske udvikling af Ilaris hos over 2.600 patienter blev ingen anafylaktoide eller anafylaktiske reaktioner rapporteret. 
During clinical development of Ilaris in over 2,600 patients, no anaphylactoid or anaphylactic reactions were reported.
Patienter med Stills sygdom kan udvikle en tilstand, der kaldes makrofag-aktiverings-syndrom (MAS), som kan være livstruende. 
Patients with Still's disease may develop a condition called macrophage activation syndrome (MAS), which can be life-threatening.
Hvis du har behov for yderligere behandling med Ilaris og fik lindring ved den sidste dosis, skal du vente mindst 12 uger inden næste dosis. 
If you need another treatment with Ilaris, and got relief from the last dose, you must wait at least 12 weeks before the next dose.
Fortæl det straks til din læge, hvis du oplever nogen af disse bivirkninger: 
Tell your doctor immediately, if you notice any of the side effects below:
Din læge vil tale med dig om behovet for at starte eller justere en urat-sænkende behandling for at sænke urinsyreniveauet i din krop. 
Your doctor will discuss with you the need to start or adjust a urate lowering therapy to lower the uric acid level in your blood.
Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger med hensyn til reproduktionstoksicitet (se pkt. 
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Table 5 Virkning i den totale studiepopulation og i en undergruppe af patienter, der aktuelt får ULT, og som ikke er i stand til at bruge hverken NSAID eller colchicin 
Table 5 Efficacy for the overall study population and in a subgroup of patients currently using ULT and unable to use both NSAIDs and colchicine
Det gennemsnitlige antal urinsyregigtanfald i de foregående 12 måneder var 6,5. 
The mean number of gouty arthritis attacks in the previous 12 months was 6.5.
Forhøjede niveauer af transaminaser er i sjældne tilfælde set hos CAPS-patienter. 
Elevations of transaminases have been observed rarely in CAPS patients.
Hvis lægemidlet ikke anvendes straks, er opbevaringstider og -betingelser inden anvendelse brugerens eget ansvar og bør normalt ikke være mere end 24 timer ved 2 °C - 8 °C. 
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C.
Effektresultaterne i en mere stringent undergruppe begrænset til patienter i aktuel ULT (N=62) er vist i Tabel 5. 
Efficacy results for a more stringent subgroup limited to current users of ULT (N=62) are presented in Table 5.
Infektioner i de øvre luftveje var den hyppigst indberettede infektion. 
Infections of the upper respiratory tract were the most frequently reported infection events.
Kvinder i den fertile alder / Kontraception til mænd og kvinder 
Women of childbearing potential / Contraception in males and females
Desuden blev 6 pædiatriske patienter under 2 år undersøgt i et mindre åbent studie. 
Additionally, 6 paediatric patients under the age of 2 years were evaluated in a small open-label clinical study.
Canakinumab er forbundet med øget incidens af alvorlige infektioner. 
Canakinumab is associated with an increased incidence of serious infections.
Canakinumab bindes til serum IL-1 beta. 
Canakinumab binds to serum IL-1 beta.
Det estimerede steady state-AUCtau var 636,7 ± 260,2 μg∙dag/ml. 
The estimated steady state AUCtau was 636.7 ± 260.2 μg*d/ml.
Der blev ikke set signifikante forskelle i sikkerhedsprofilen hos patienter ≥65 år. 
There is no significant difference in safety profile observed in patients ≥ 65 years of age.
I alt har 324 SJIA-patienter i alderen 2 til <20 år fået Ilaris i interventionskliniske studier, herunder 293 patienter i alderen 2 til <16 år, 21 patienter i alderen 16 til <18 år og 10 patienter i alderen 18 til <20 år. 
A total of 324 SJIA patients aged 2 to < 20 years have received Ilaris in interventional clinical trials, including 293 patients aged 2 to < 16 years old, 21 patients aged 16 to < 18 years old and 10 patients aged 18 to < 20 years old.
I alt blev 185 patienter i alderen 28 dage og derover inkluderet, og i alt blev 181 patienter i alderen 2 år og derover randomiseret i studiets del II. 
A total of 185 patients aged 28 days and above were enrolled and a total of 181 patients aged 2 years and above were randomised in part II of the study.
Multipakning: 4 (4x1) hætteglas. 
Multipack: 4 (4x1) vials.
Derfor var Tmax kortere (3,6 dage) hos yngre SJIA-patienter (2-3 år) sammenlignet med ældre SJIA-patienter (12-19 år; Tmax 6 dage). 
Accordingly, Tmax was shorter (3.6 days) in younger SJIA patients (2-3 years) compared to older SJIA patients (12-19 years; Tmax 6 days).
Den kliniske erfaring med dosering i intervaller på mindre end 4 uger eller med doser over 600 mg eller 8 mg/kg er begrænset. 
Clinical experience with dosing at intervals of less than 4 weeks or at doses above 600 mg or 8 mg/kg is limited.
Antistoffer mod Ilaris er set hos ca. 1,5 %, 3 % og 2 % af patienterne behandlet med Ilaris for henholdsvis CAPS, SJIA og urinsyregigt. 
Antibodies against Ilaris were observed in approximately 1.5%, 3% and 2% of the patients treated with Ilaris for CAPS, SJIA and gouty arthritis, respectively.
Injektion i arvæv bør undgås, da det kan medføre utilstrækkelig eksponering af canakinumab. 
Injection into scar tissue should be avoided as this may result in insufficient exposure to canakinumab.
Samtidig behandling med ULT blev rapporteret for 42 % af patienterne ved inklusionen. 
Concomitant treatment with ULTs was reported by 42% of patients at entry.
I tidlige kliniske studier, fik patienter og raske frivillige doser så højt som 10 mg/kg, administreret intravenøst eller subkutant, uden tegn på akut toksicitet. 
In early clinical trials, patients and healthy volunteers received doses as high as 10 mg/kg, administered intravenously or subcutaneously, without evidence of acute toxicity.
Af i alt 128 patienter, der blev inkluderet i del I og tog kortikosteroider, forsøgte 92 steroidreduktion. 
Of the total 128 patients who entered Part I taking corticosteroids, 92 attempted corticosteroid tapering.
- Del I: Patienter i hver sygdomskohorte i alderen 2 år og derover indtrådte i en screeningsperiode på 12 uger, hvor de blev evalueret for indtræden af sygdomsopblussen. 
- Part I: Patients in each disease cohort aged 2 years and older entered a 12-week screening period during which they were evaluated for the onset of disease flare.
Resultaterne af et studie hos raske voksne forsøgspersoner viste, at en enkelt dosis Ilaris 300 mg ikke påvirkede induktion og persistens af antistofrespons efter vaccination med influenzavaccine eller med meningokokvaccine baseret på glykolyseret protein. 
The results of a study in healthy adult subjects demonstrated that a single dose of Ilaris 300 mg did not affect the induction and persistence of antibody responses after vaccination with influenza or glycosylated protein based meningococcus vaccines.
9/L) og leukopeni er observeret ved lægemidler, der hæmmer IL-1, inklusive canakinumab. 
9/l) and leukopenia have been observed with medicinal products that inhibit IL-1, including canakinumab.
Ilaris må kun indsprøjtes af sundhedspersonale. 
Ilaris should be injected by a healthcare professional only.
Der foreligger kun begrænsede data om brug af canakinumab hos gravide kvinder. 
There is a limited amount of data from the use of canakinumab in pregnant women.
Om end begrænset indikerer evidensen fra kliniske studier, at patienter, der ikke reagerer på tocilizumab eller anakinra, kan reagere på canakinumab. 
Although limited, evidence from the clinical trials suggests that patients not responding to tocilizumab or anakinra may respond to canakinumab.
Forsøg ikke selv at give indsprøjtninger, hvis du ikke har fået grundig undervisning i det, eller hvis du er i tvivl om, hvordan du skal gøre. 
Do not try to administer an injection yourself if you have not been properly trained or if you are not sure how to do it.
Øget incidens af alvorlige infektioner er blevet sat i forbindelse med administration af en anden IL-1blokker i kombination med TNF-hæmmere. 
An increased incidence of serious infections has been associated with administration of another IL-1 blocker in combination with TNF inhibitors.
Patienter, som ikke reagerer på den initiale behandling, bør ikke genbehandles med canakinumab. 
Patients who do not respond to initial treatment should not be re-treated with canakinumab.
Disse data viste lignende forbedringer fra baseline til uge 12 i de tilpassede pædiatriske ACR-respons og komponenter, der blev observeret i det placebokontrollerede studie (G2305). 
These data showed similar improvements from baseline to week 12 in the adapted paediatric ACR responses and its components to those observed in the placebo controlled study (G2305).
Ved urinsyregigt bør lægen have erfaring med brug af biologiske lægemidler, og Ilaris bør administreres af en sundhedsfaglig person. 
For gouty arthritis, the physician should be experienced in the use of biologics and Ilaris should be administered by a healthcare professional.
Anvend ikke medicinen efter den udløbsdato, der er anført på etiketten og æsken. 
- Do not use this medicine after the expiry date which is stated on the label and carton.
Det tilsyneladende fordelingsvolumen (V/F) var 4,96 l ved en legemsvægt på 55 kg. 
The apparent volume of distribution (V/F) was 4.96 l at body weight of 55 kg.
Urinsyregigt er forårsaget af dannelse af uratkrystaller. 
Gouty arthritis is caused by the formation of urate crystals.
BEMÆRK: Den nødvendige mængde afhænger af, hvilken dosis der skal indsprøjtes. 
NOTE: The required amount depends on the dose to be administered.
Dyrestudier indikerer, at canakinumab passerer placenta og kan detekteres hos fostret. 
Animal studies indicate that canakinumab crosses the placenta and is detectable in the foetus.
Kontakt lægen, før du tager Ilaris, hvis noget af nedenstående gælder for dig: hvis du i øjeblikket har en infektion eller tidligere har haft tilbagevendende infektioner, eller hvis du fx har et nedsat antal hvide blodlegemer, hvilket gør dig mere modtagelig for infektioner. 
Talk to your doctor before using Ilaris if any of the following applies to you: if you currently have an infection or if you have had repeated infections or a condition such as a known low level of white blood cells which makes you more likely to get infections.
Den kausale sammenhæng mellem canakinumab og disse tilfælde kan ikke udelukkes. 
The causal relationship of canakinumab to these events cannot be excluded.
Primært endepunkt (opblussen) Andelen af patienter med sygdomsopblussen i del II 
Primary endpoint (flare) Proportion of patients with disease flare in Part II
Hvis du får et nyt anfald, kan din læge overveje at give dig en ny dosis Ilaris, men ikke tidligere end 12 uger efter sidste behandling. 
If you experience a new attack, your doctor may consider giving you a new dose of Ilaris but not earlier than 12 weeks from the previous dose.
Der er ikke udført formelle undersøgelser af den potentielle virkning af canakinumab på human fertilitet. 
Formal studies of the potential effect of canakinumab on human fertility have not been conducted.
Periodiske febersyndromer 
Periodic fever syndromes
Patienter som opretholdte inaktiv sygdomsstatus i yderligere 6 måneder ved den laveste dosis fik lov til at seponere canakinumab. 
Patients who maintained inactive disease status for 6 additional months at this lowest dose regimen were allowed to discontinue canakinumab.
Resultaterne af et 56 ugers åbent studie hos CAPS-patienter i alderen 4 år og yngre viste, at alle patienter, der fik ikke-levende, standard børnevacciner udviklede beskyttende antistofniveauer. 
The results of a 56-week, open label study in CAPS patients aged 4 years and younger demonstrated that all patients who received non-live, standard of care childhood vaccinations developed protective antibody levels.
Det vides ikke, om interleukin-1- (IL-1) hæmmere som fx canakinumab øger risikoen for reaktivering af tuberkulose. 
It is unknown whether the use of interleukin-1 (IL-1) inhibitors such as canakinumab increases the risk of reactivation of tuberculosis.
Hvis en patient bliver neutropen eller leukopen, skal WBC monitoreres tæt og seponering overvejes. 
If a patient becomes neutropenic or leukopenic, the WBC counts should be monitored closely and treatment discontinuation should be considered.
Der var intet, der tydede på accelereret clearance eller tidsafhængig ændring i canakinumabs farmakokinetiske egenskaber efter gentagen administration. 
There was no indication of accelerated clearance or time-dependent change in the pharmacokinetic properties of canakinumab following repeated administration.
Baseret på erfaring fra kliniske forsøg påvirker canakinumab tilsyneladende ikke incidencen af MAS hos SJIA-patienter, men en endelig konklusion kan ikke drages. 
Based on clinical trial experience, canakinumab does not appear to increase the incidence of MAS in SJIA patients, but no definitive conclusion can be made.
Behandling med canakinumab bør ikke initieres hos patienter med neutropeni eller leukopeni. 
Treatment with canakinumab should not be initiated in patients with neutropenia or leukopenia.
Relevante screeningstest (fx tuberkulin hudtest, interferon gamma frigivelsestest eller røntgen af thorax) skal udføres hos alle patienter (lokale anbefalinger kan være gældende). 
Appropriate screening tests (e.g. tuberculin skin test, interferon gamma release assay or chest X-ray) should be performed in all patients (local recommendations may apply).
Ved uge 12 var de tilpassede pædiatriske ACR30-, 50-, 70-, 90- og 100-respons henholdsvis 70 %, 69 %, 61 %, 49 % og 30 %, og 28 % af patienterne havde inaktiv sygdom (N=178). 
At week 12, the adapted paediatric ACR30, 50, 70, 90 and 100 responses were: 70%, 69%, 61%, 49% and 30%, respectively and 28% of patients had inactive disease (N=178).
Data fra de første 12 ugers canakinumab-behandling fra studierne G2305 og G2301 og forlængelsesstudiet blev samlet for at vurdere, hvorvidt effekten blev opretholdt. 
Data from the first 12 weeks of canakinumab treatment from studies G2305, G2301 and the extension study were pooled to assess maintenance of efficacy.
Reduktion af kortikosteroiddosis: 
Corticosteroid dose tapering:
Størstedelen af de pædiatriske patienter opnåede forbedring i kliniske symptomer og objektive inflammationsmarkører (fx SAA og CRP). 
The majority of paediatric patients achieved improvement in clinical symptoms and objective markers of inflammation (e.g. SAA and CRP).
Del III: Patienter, der blev behandlet med placebo i del II, og som havde opblussen, genvandt og opretholdt klinisk og serologisk respons efter indtræden i den åbne studieudvidelse med canakinumab. 
Part III: Patients treated with placebo in Part II who flared regained and maintained clinical and serological response following entry into the open-label canakinumab extension.
Dette er klinisk relevant for CYP-substrater med et snævert terapeutisk vindue, hvor dosis justeres individuelt. 
This is clinically relevant for CYP450 substrates with a narrow therapeutic index where the dose is individually adjusted.
Ilaris er beregnet til subkutan anvendelse. 
Ilaris is intended for subcutaneous use.
Det sammensatte primære endepunkt var: (I) urinsyregigt-smerteintensitet (visual analogue scale, VAS) 72 timer efter indtagelse, og (II) tid til første nye anfald af urinsyregigt. 
The co-primary endpoints were: (i) gouty arthritis pain intensity (visual analogue scale, VAS) at 72 hours post-dose, and (ii) time to first new gouty arthritis attack.
Det andet studie var et open-label studie med canakinumab for at vurdere effekten og sikkerheden hos japanske CAPS-patienter i 24 uger, med en ekstensionsfase op til 48 uger. 
The other was an open-label study with canakinumab to evaluate the efficacy and safety in Japanese CAPS patients for 24 weeks, with an extension phase up to 48 weeks.
Canakinumab havde ingen effekt på de mandlige fertilitetsparametre hos egernaber (C. jacchus). 
Canakinumab had no effect on male fertility parameters in marmosets (C. jacchus).
(Der kan være opløsning tilbage i hætteglasset). 
(There may be solution remaining in the vial.)
Isolerede tilfælde af usædvanlige eller opportunistiske infektioner (inklusive aspergillose, atypiske mycopakterielle infektioner, herpes zoster) er rapporteret under behandling med canakinumab. 
Isolated cases of unusual or opportunistic infections (including aspergillosis, atypical mycobacterial infections, herpes zoster) have been reported during canakinumab treatment.
57 (62 %) af de 92 patienter, der forsøgte steroidreduktion, var i stand til successfuldt at reducere deres kortikosteroiddosis, og 42 (46 %) stoppede med kortikosteroider. 
Fifty-seven (62%) of the 92 patients who attempted to taper were able to successfully taper their corticosteroid dose and 42 (46%) discontinued corticosteroids.
For den totale studiepopulation var smerteintensiteten statistisk signifikant lavere for canakinumab 150 mg sammenlignet med triamcinolonacetonid ved 72 timer. 
For the overall study population, pain intensity was statistically significantly lower for canakinumab 150 mg compared with triamcinolone acetonide at 72 hours.
Makrofag-aktiveringssyndrom (MAS) er en kendt, livstruende tilstand, der kan udvikles hos patienter med reumatiske lidelser, specielt Stills sygdom. 
Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with rheumatic conditions, in particular Still's disease.
Hvad angik det primære effektendepunkt, var canakinumab superior i forhold til placebo for alle tre sygdomskohorter. 
For the primary efficacy endpoint, canakinumab was superior to placebo for all three disease cohorts.
Omkring en tredjedel af de inkluderede patienter (76 [33,8 %] i canakinumab-gruppen og 84 [36,7 %] i triamcinolonacetonid-gruppen) var dokumenteret ikke i stand (intolerance, kontraindikationer eller manglende respons) til at bruge hverken NSAID eller colchicin. 
Approximately one-third of the patients enrolled (76 [33.8%] in the canakinumab group and 84 [36.7%] in the triamcinolone acetonide group) had documented inability (intolerance, contraindication or lack of response) to use both NSAIDs and colchicine.
17 patienter (inklusive 6 patienter under 2 år) blev evalueret; vægtbaserede startdoser var 2-8 mg/kg. 
Seventeen patients (including 6 patients under the age of 2 years) were evaluated, using weight-based starting doses of 2-8 mg/kg.
Det blev estimeret til 6,2 liter hos en CAPS-patient med en legemsvægt på 70 kg. 
It was estimated to be 6.2 litres in a CAPS patient of body weight 70 kg.
Det anbefales at vælge et nyt injektionssted ved hver injektion for at undgå ømhed. 
It is recommended to select a different injection site each time the product is injected to avoid soreness.
Nålen skal ikke være nede i injektionsvæsken på dette tidspunkt. 
The needle should not be in the liquid at this point.
Det pivotale studie bestod af et tredelt multicenterstudie på 48 uger, dvs. en åben periode på 8 uger (del I), en randomiseret, dobbeltblindet, placebokontrolleret seponeringsperiode på 24 uger (del II), efterfulgt af en åben periode på 16 uger (del III). 
The pivotal study consisted of a 48-week three-part multicentre study, i.e. an 8-week open-label period (Part I), a 24-week randomised, double-blind, placebo-controlled withdrawal period (Part II), followed by a 16-week open-label period (Part III).
Denne patient indtrådte i studiet med immun trombocytopenisk purpura i anamnesen og en aktiv klinisk tilstand med anormal leverfunktion. 
This patient presented at study entry with a history of immune thrombocytopenic purpura and an active medical condition of abnormal hepatic function.
Laboratorieparametre, såsom højt niveau af CRP og SAA, høje neutrofil- og trombocyttal, normaliseredes hurtigt inden for nogle dage efter injektion af canakinumab. 
Laboratory parameters such as high CRP and SAA, high neutrophils and platelet counts normalised rapidly within days of canakinumab injection.
- Del IV: Alle patienter fra del III, der blev behandlet med canakinumab, var egnede til at indtræde i en forlænget åben behandlingsperiode på 72 uger. 
- Part IV: All Part III patients treated with canakinumab were eligible to enter into a 72-week open-label treatment extension period.
Hvis du stopper behandlingen med Ilaris, kan din tilstand forværres. 
Stopping your treatment with Ilaris may cause your condition to get worse.
Stills sygdom (AOSD og SJIA) 
Still's disease (AOSD and SJIA)
Hos patienter med periodiske febersyndromer (CAPS, TRAPS, HIDS/MKD og FMF) danner kroppen for meget IL-1 beta. 
In patients with periodic fever syndromes (CAPS, TRAPS, HIDS/MKD and FMF), the body produces too much IL-1 beta.
Det vides ikke, om canakinumab udskilles i human mælk. 
It is unknown whether canakinumab is excreted in human milk.
Inden initiering af canakinumab-behandling anbefales det, at voksne og pædiatriske patienter får alle hensigtsmæssige vaccinationer, herunder også pneumokokvaccine og inaktiveret influenzavaccine (se pkt. 
Prior to initiation of canakinumab therapy it is recommended that adult and paediatric patients receive all vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine (see section 4.5).