natgillin/translations-raw huggingface dataset:
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).
Ophør af sygdomsopblussen blev opnået ved uge 5, og patienten havde ikke fået nogen ny opblussen ved afslutning af studiets del II (uge 16).
Resolution of disease flare was achieved by week 5 and the patient had not experienced any new flare at the end of Part II of the study (week 16).
Genbrug aldrig sprøjter eller kanyler.
Never re-use syringes or needles.
Hvert hætteglas er til engangsbrug og indeholder en enkelt dosis til én patient.
Each vial is for single use in a single patient, for a single dose.
Omkring 22% af patienterne der fik canakinumab krævede dosisjustering, men kun en lille procentdel (1,2%) ophørte med canakinumab på grund af manglende terapeutisk effekt.
Although approximately 22% of patients receiving canakinumab required dose adjustment, only a small percentage of patients (1.2%) discontinued canakinumab due to lack of therapeutic effect.
Beskadiget hud og områder med blå mærker eller udslæt bør undgås.
Broken skin and areas which are bruised or covered by a rash should be avoided.
Urinsyregigt: Ilaris frarådes til børn og unge under 18 år.
Gouty arthritis: Ilaris is not recommended for children or adolescents under 18 years of age.
Virkningen af canakinumab ved aktiv SJIA blev vurderet i to pivotale studier (G2305 og G2301).
The efficacy of canakinumab for the treatment of active SJIA was assessed in two pivotal studies (G2305 and G2301).
Ud fra en mikrobiologisk betragtning skal lægemidlet anvendes straks efter åbning.
From a microbiological point of view, the product should be used immediately after first opening.
Efter rekonstitution bør lægemidlet ud fra en mikrobiologisk betragtning anvendes straks.
After reconstitution, from a microbiological point of view, the product should be used immediately.
Læger bør udvise forsigtighed ved administration af canakinumab til patienter med aktuel infektion, anamnestiske oplysninger om tilbagevendende infektioner, eller underliggende tilstande, der kan prædisponere for infektioner.
Physicians should exercise caution when administering canakinumab to patients with infections, a history of recurring infections, or underlying conditions which may predispose them to infections.
Selvom der forekom reduktion i neutrofiltallet af ≥grad 2 hos 6,5 % af patienterne (almindelig) og reduktion af grad 1 hos 9,5 % af patienterne, er nedsat neutrofiltal generelt forbigående, og neutropeni-relateret infektion er ikke blevet identificeret som en bivirkning.
Although ≥ Grade 2 reductions in neutrophil count occurred in 6.5% of patients (common) and Grade 1 reductions occurred in 9.5% of patients, the reductions are generally transient and neutropenia-associated infection has not been identified as an adverse reaction.
AUCSS i de enkelte aldersgrupper var 692, 615, 707 og 742 µg*dag/ml for henholdsvis 2-3, 4-5, 6-11 og 12-19 år.
The AUCss4w in each age group was 692, 615, 707 and 742 µg*d/ml for 2-3, 4-5, 6-11, and 12-19 years old, respectively.
Du frarådes at blive gravid og skal anvende sikker prævention, mens du tager Ilaris og i mindst 3 måneder efter den sidste Ilaris-behandling.
You are advised to avoid becoming pregnant and must use adequate contraception while using Ilaris and for at least 3 months after the last Ilaris treatment.
Patienten, plejepersonen og lægen bør i fællesskab beslutte, hvem der skal indsprøjte Ilaris.
The patient or caregiver and the doctor should decide together who will administer the Ilaris injections.
Sygdomsaktiviten blev bedømt som fraværende eller mild/moderat for mere end 90% af patienterne for alle post-baseline tidspunkter i studiet, og medianen af serologiske markører for inflammation (CRP og SAA) var normal (<10 mg/l) for alle post-baseline tidspunkter.
Disease activity was rated as absent or mild/moderate in more than 90% of patients at all post-baseline time points in the study, and median serological markers of inflammation (CRP and SAA) were normal (< 10 mg/litre) at all post-baseline time points.
Disse krystaller forårsager overdreven produktion af IL-1 beta, som til gengæld kan medføre pludselig, kraftig smerte, rødme, varme og hævelse i et led (kendt som podagra).
These crystals cause excessive production of IL-1 beta, which in turn can lead to sudden, severe pain, redness, warmth and swelling in a joint (known as a gouty arthritis attack).
Tag hætteglasset ud af køleskabet og kontroller udløbsdatoen på hætteglasset.
After removing the vial from the refrigerator, check the expiry date on the vial.
Indehaveren af markedsføringstilladelsen har gennemført fire pædiatriske undersøgelsesprogrammer for Ilaris (for henholdsvis CAPS, SJIA, FMF - HIDS/MKD og TRAPS).
The Marketing Authorisation Holder has completed four Paediatric Investigation Plans for Ilaris (for CAPS, SJIA, FMF - HIDS/MKD and TRAPS respectively).
Canakinumab havde også en superior effekt sammenlignet med placebo på de sekundære endepunkter PGA <2 og CRP ≤10 mg/l i alle tre kohorter.
Canakinumab also demonstrated superior efficacy compared to placebo on the secondary endpoints of PGA < 2 and CRP ≤ 10 mg/l in all three cohorts.
1Ved SJIA.
1 In SJIA
Ilaris kan anvendes alene eller sammen med methotrexat.
Ilaris can be used alone or in combination with methotrexate.
Du må ikke prøve at opvarme hætteglasset.
Do not try to heat the vial.
Den mediane ændring i smertescore hos canakinumab-behandlede patienter var vedvarende på dag 29.
The mean change in pain score among canakinumab treated patients was consistent at day 29.
Der blev ikke observeret antistoffer mod Ilaris hos TRAPS-, HIDS/MKD- og FMF-patienter, som blev behandlet med doser på 150 mg og 300 mg over en 16 ugers behandlingsperiode.
There were no antibodies against Ilaris observed in TRAPS, HIDS/MKD and FMF patients treated with doses of 150 mg and 300 mg over 16 weeks of treatment.
Levende vacciner: Det anbefales, at du undgår at blive vaccineret med en type vacciner, der kaldes ”levende vacciner”, mens du bliver behandlet med Ilaris.
Live vaccines: You are advised to avoid being vaccinated with a type of vaccine called a live vaccine while you are being treated with Ilaris.
Dit barn må ikke få levende vacciner før mindst 16 uger efter, at du har fået din sidste dosis af canakunimab før fødslen.
Your baby should not receive live vaccines until at least 16 weeks after you received your last dose of canakinumab before giving birth.
SJIA hos unge patienter og AOSD
SJIA in young adults and AOSD
Se også punkt 3, ”Hvis du giver dig selv indsprøjtning af Ilaris eller giver en patient Ilaris”.
See also section 3, “Injecting Ilaris yourself or injecting a patient with Ilaris”.
I den totale studiepopulation havde patienter på ULT en mindre udtalt behandlingsforskel i både smertereduktion og reduktion af risikoen for efterfølgende urinsyregigt-anfald sammenlignet med patienter, der ikke var på ULT.
In the overall study population, patients on ULT had a less pronounced treatment difference in both pain reduction and reduction in the risk of subsequent gouty arthritis attacks compared to patients not on ULT.
Din læge vil muligvis kontrollere, om du har tuberkulose, ved brug af en specifik test. hvis du har symptomer på en leversygdom som fx gul hud og øjne, kvalme, appetitløshed, mørk urin og lys afføring.
Your doctor may check whether you have tuberculosis using a specific test. if you have signs of a liver disorder such as yellow skin and eyes, nausea, loss of appetite, darkcoloured urine and light-coloured stools.
Lægen eller sygeplejersken vil vise dig, hvordan indsprøjtninger med Ilaris skal gives.
The doctor or nurse will demonstrate how to administer Ilaris injections.
Familiær middelhavsfeber (FMF)
Familial Mediterranean fever (FMF)
En ny opblussen blev defineret som en PGA-score ≥ 2 (let, moderat eller svær sygdom) og CRP ≥30 mg/l.
A new flare was defined as a PGA score ≥ 2 (“mild, moderate, or severe disease”) and CRP ≥ 30 mg/l.
Canakinumabs fordelingsvolumen (Vss) varierede i forhold til legemsvægt.
The distribution volume (Vss) of canakinumab varied according to body weight.
Sikkerhedsresultaterne viste en øget forekomst af bivirkninger for canakinumab sammenlignet med triamcinolonacetonid med 66 % henholdsvis 53 % af patienterne, der rapporterede en hvilken som helst bivirkning, og 20 % henholdsvis 10 % af patienterne, der rapporterede en infektionsrelateret bivirkning i løbet af 24 uger.
Safety results showed an increased incidence of adverse events for canakinumab compared to triamcinolone acetonide, with 66% vs 53% of patients reporting any adverse event and 20% vs 10% of patients reporting an infection adverse event over 24 weeks.
Nedsat antal hvide blodlegemer, som forebygger infektioner (neutropeni).
Drop in level of white blood cells which help prevent infection (neutropenia).
Hvis vaccination med levende vacciner er indiceret efter initiering af canakinumab-behandling, anbefales det at vente mindst 3 måneder efter den sidste canakinumab-injektion og før den næste injektion (se pkt.
Should vaccination with live vaccines be indicated after initiation of canakinumab treatment, the recommendation is to wait for at least 3 months after the last canakinumab injection and before the next one (see section 4.4).
Sekundære endepunkter var alle baseret på resultater ved uge 16 (afslutningen af del II) og omfattede andelen af patienter, der opnåede PGA-score <2, andelen af patienter med serologisk remission (defineret som CRP ≤10 mg/l) og andelen af patienter med normaliseret SAA-niveau (defineret som SAA ≤10 mg/l).
Secondary endpoints, all based on week 16 results (end of Part II), included the proportion of patients who achieved a PGA score of < 2, the proportion of patients with serological remission (defined as CRP ≤ 10 mg/l), and the proportion of patients with a normalised SAA level (defined as SAA ≤ 10 mg/l).
Unormalt niveau af triglycerider i blodet (forstyrrelser i lipidstofskiftet).
Abnormal levels of triglycerides in your blood (lipid metabolism disorder).
Sikkerhedsprofilen for canakinumab, der blev observeret efter langtidsbehandling under disse forhold, svarede til den sikkerhedsprofil der blev observeret i interventionsstudier i CAPS patienter.
The safety profile of canakinumab observed following long-term treatment in this setting was consistent with what has been observed in interventional studies in CAPS patients.
Behandling med canakinumab inducerede en smertereduktion og reducerede risikoen for efterfølgende anfald hos patienter, der fik ULT, og som ikke kunne bruge hverken NSAID eller colchicin, selvom den observerede behandlingsforskel sammenlignet med triamcinolonacetonid var mindre udtalt end for den totale studiepopulation.
Treatment with canakinumab induced a reduction of pain and reduced the risk of subsequent attacks in patients using ULT and unable to use both NSAIDs and colchicine, although the observed treatment difference compared to triamcinolone acetonide was less pronounced than with the overall study population.
Der er ikke behov for dosisjustering hos patienter med nedsat nyrefunktion.
No dose adjustment is needed in patients with renal impairment.
Det vides ikke, om Ilaris udskilles i mælken hos mennesker.
It is not known whether Ilaris passes into human milk.
Lad hætteglasset stå uåbnet i 10 minutter, så indholdet kan opnå stuetemperatur.
Let the vial stand unopened for 10 minutes to bring the contents to room temperature.
Hos ca. 12 % af de CAPS-patienter, der blev testet med en tuberkulintest (purified protein derivative (PPD)) i kliniske forsøg, gav opfølgende test et positivt resultat under behandling med canakinumab uden klinisk evidens for en latent eller aktiv tuberkuloseinfektion.
In approximately 12% of CAPS patients tested with a PPD (purified protein derivative) skin test in clinical trials, follow-up testing yielded a positive test result while treated with canakinumab without clinical evidence of a latent or active tuberculosis infection.
I en samlet effektanalyse af disse to studier opnåede 65,6 % af de patienter, der ikke tidligere var blevet behandlet med canakinumab, fuldt respons ved 150 mg eller 2 mg/kg, mens 85,2 % af patienterne opnåede fuldt respons ved en hvilken som helst dosis.
In the pooled efficacy analysis for these two studies, 65.6% of patients who had not previously been treated with canakinumab achieved complete response at 150 mg or 2 mg/kg, while 85.2% of patients achieved complete response at any dose.
Del I: Et fuldstændigt klinisk og biomarkørmæssigt respons på canakinumab (defineret som sammensætning af dels en samlet lægelig vurdering af autoinflammatorisk sygdom og dels af hudsygdom ≤ minimal og CRP- eller SAA-værdier <10 mg/liter) sås hos 97 % af patienterne og viste sig inden for 7 dage efter indledning af behandlingen.
Part I: A complete clinical and biomarker response to canakinumab (defined as composite of physician's global assessment on autoinflammatory and on skin disease ≤ minimal and CRP or SAA values < 10 mg/litre) was observed in 97% of patients and appeared within 7 days of initiation of treatment.
Levende vacciner bør derfor ikke gives sideløbende med canakinumab, medmindre fordelene tydeligt opvejer risici.
Therefore, live vaccines should not be given concurrently with canakinumab unless the benefits clearly outweigh the risks.
Din læge vil tale med dig om de mulige risici, der er ved at tage Ilaris under graviditeten.
Your doctor will discuss with you the potential risks of taking Ilaris during pregnancy.
Den rekonstituerede injektionsvæske bør anvendes straks, men kan anvendes inden for 24 timer, hvis den opbevares i køleskab.
The reconstituted solution should ideally be used immediately, but can still be used for up to 24 hours if stored in a refrigerator.
To ikke-randomiserede HIDS/MKD-patienter i alderen >28 dage, men <2 år blev inkluderet i studiet og fik canakinumab.
Two non-randomised HIDS/MKD patients aged > 28 days but < 2 years were included in the study and received canakinumab.
Neutropeni (absolut neutrofiltal [ANC] <1,5 x 10
Neutropenia (absolute neutrophil count [ANC] < 1.5 x 10
Det betyder, at det bliver sprøjtet ind i fedtvævet lige under huden med en kort kanyle.
This means that it is injected through a short needle into the fatty tissue just under the skin.
Kontrollér, at al opløsningen er i bunden af hætteglasset.
Make sure all of the solution is in the bottom of the vial.
Baseret på en populationsfarmakokinetisk modelleringsanalyse var de forventede eksponeringer efter en dosis på 2 mg/kg sammenlignelige på tværs af CAPS-pædiatriske aldersgrupper, men var omkring 40 % lavere hos pædiatriske patienter med meget lav kropsvægt (fx 10 kg) end hos voksne patienter (150 mg dosis).
Based on the population pharmacokinetic modelling analysis, the expected exposures after a dose of 2 mg/kg were comparable across the CAPS paediatric age groups, but were approximately 40% lower in paediatric patients of very low body weight (e.g. 10 kg) than in adult patients (150 mg dose).
I kliniske studier er canakinumab blevet sikkert administreret sammen med ULT.
In clinical studies, canakinumab has been safely administered with ULT.
Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle undersøgelser af krydsreaktivitet, toksicitet efter gentagne doser, immunotoksicitet, reproduktions- og udviklingstoksicitet.
Non-clinical data reveal no special hazard for humans based on conventional studies of crossreactivity, repeated dose toxicity, immunotoxicity, toxicity to reproduction and development.
Der sås signifikante forbedringer af den lægelige kliniske vurdering af autoinflammatorisk sygdomsaktivitet: samlet vurdering af autoinflammatorisk sygdomsaktivitet, vurdering af hudsygdom (urtikarielt hududslæt), artralgi, myalgi, hovedpine/migræne, konjunktivitis, træthed/utilpashed, vurdering af andre relaterede symptomer og af patientens vurdering af symptomer.
Significant improvements were seen in physician's clinical assessment of autoinflammatory disease activity: global assessment of autoinflammatory disease activity, assessment of skin disease (urticarial skin rash), arthralgia, myalgia, headache/migraine, conjunctivitis, fatigue/malaise, assessment of other related symptoms, and patient's assessment of symptoms.
• Familiær middelhavsfeber (FMF).
• Familial Mediterranean fever (FMF).
Hos patienter, hvor lægemiddelet virker, og som har behov for genbehandling, bør der være et interval på mindst 12 uger, inden en ny dosis canakinumab administreres (se pkt.
In patients who respond and require re-treatment, there should be an interval of at least 12 weeks before a new dose of canakinumab may be administered (see section 5.2).
63 ud af de 100 patienter, der blev inkluderet i del II, og som fik enten placebo eller canakinumab, oplevede ikke udbrud i observationsperioden (op til maksimalt 80 uger).
Sixty-three of the 100 patients entering Part II, whether assigned to placebo or canakinumab, did not experience a flare over the observation period (up to a maximum of 80 weeks).
Ilaris er indiceret til behandling af følgende autoinflammatoriske periodiske febersyndromer hos voksne, unge og børn på 2 år og derover:
Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:
Aktivering af makrofager og samtidig overproduktion af IL-1 beta resulterer i et akut smertefuldt inflammatorisk respons.
Activation of macrophages and concomitant over-production of IL-1 beta results in an acute painful inflammatory response.
I længerevarende, open-label studier med dosisoptrapning blev infektioner (gastroenteritis, luftvejsinfektion, infektion i de øvre luftveje), opkastning og svimmelhed rapporteret hyppigere i gruppen med dosis på 600 mg eller 8 mg/kg sammenlignet med andre grupper.
In the long-term, open-label studies with dose escalation, events of infections (gastroenteritis, respiratory tract infection, upper respiratory tract infection), vomiting and dizziness were more frequently reported in the 600 mg or 8 mg/kg dose group than in other dose groups.
Svampeinfektion i skeden (vulvovaginal candidiasis).
Candida - vaginal yeast infection (vulvovaginal candidiasis).
Canakinumab's effekt og sikkerhed er påvist hos i alt 211 voksne og pædiatriske patienter med varierende sygdomssværhedsgrader og forskellige CAPS-fænotyper (herunder FCAS/FCU, MWS og NOMID/CINCA).
The efficacy and safety of canakinumab have been demonstrated in a total of 211 adult and paediatric patients with varying degrees of disease severity and different CAPS phenotypes (including FCAS/FCU, MWS, and NOMID/CINCA).
Det anbefales, at du undgår at blive vaccineret med en type vacciner, der kaldes levende vacciner, mens du bliver behandlet med Ilaris (se også ”Brug af anden medicin sammen med Ilaris”).
You are advised to avoid being vaccinated with a type of vaccine called a live vaccine while being treated with Ilaris (see also “Other medicines and Ilaris”).