natgillin/translations-raw huggingface dataset:
I uge 12 var der en statistisk signifikant forbedring i SPARCC-scoren (Spondyloarthritis Research Consortium of Canada) for SI-leddet målt ved hjælp af MR hos patienter, der fik Enbrel.
At week 12, there was a statistically significant improvement in the SPARCC (Spondyloarthritis Research Consortium of Canada) score for the sacroiliac joint (SIJ) as measured by MRI for patients receiving Enbrel.
Sikkerhed og effekt ved brug af Enbrel til patienter med immunosuppression er ikke blevet vurderet.
The safety and efficacy of Enbrel in patients with immunosuppression have not been evaluated.
• Fjern plastikhætten fra Enbrel-hætteglasset (se billede 1).
• Remove the plastic cap from the Enbrel vial (see Diagram 1).
Enbrel bør derfor ikke anvendes til behandling af patienter med alkoholisk hepatitis.
Consequently, Enbrel should not be used in patients for the treatment of alcoholic hepatitis.
Den korrigerede gennemsnitlige ændring fra baseline var 3,8 for patienter i Enbrel-armen (n=95) i forhold til 0,8 for patienter i placebo-armen (n=105) (p<0,001).
Adjusted mean change from baseline was 3.8 for Enbrel treated (n=95) versus 0.8 for placebo treated (n=105) patients (p<0.001).
Der er også rapporteret om alvorlige bivirkninger for Enbrel: TNF-antagonister som Enbrel påvirker immunsystemet, og brugen af dem kan påvirke kroppens forsvar mod infektioner og cancer.
TNF-antagonists, such as Enbrel, affect the immune system and their use may affect the body's defenses against infection and cancer.
Hvis du holder op med at tage Enbrel
If you stop using Enbrel
Enbrel, alene eller i kombination med methotrexat, er vist at reducere udviklingen af ledskader, målt ved hjælp af røntgen, og at forbedre den fysiske funktion.
Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
• hvis dit barn er allergisk over for etanercept eller nogle af de andre indholdsstoffer i Enbrel (angivet i afsnit 6).
• if the child you are caring for is allergic to etanercept or any of the other ingredients of Enbrel (listed in section 6).
Patienterne var mellem 18 og 70 år gamle og havde aktiv prosiasis artrit ( 3 svulne led og  3 ømme led) i mindst en af følgende former: (1) i distale interfalangeale led, (2) polyartikulær artrit (ingen reumatoide knuder og tilstedeværelse af psoriasis), (3) arthritis mutilans, (4) asymetrisk psoriasisartrit eller (5) spondylitis-lignende ankylose.
Patients were between 18 and 70 years of age and had active psoriatic arthritis (≥ 3 swollen joints and ≥ 3 tender joints) in at least one of the following forms: (1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
Der er indberetninger om reaktivering af hepatitis B hos patienter, som tidligere havde været inficeret med hepatitis B-virus (HBV), og som samtidig fik behandling med TNF-antagonister, herunder Enbrel.
Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including Enbrel, has been reported.
Uge 52 score Remission
Week 52 scoreb
Læger skal være forsigtige, når de overvejer brug af Enbrel til patienter, der har en anamnese med tilbagevendende eller kroniske infektioner eller med tilgrundliggende sygdomstilstande, som kan prædisponere patienterne til infektioner, for eksempel fremskreden eller dårligt kontrolleret diabetes.
Physicians should exercise caution when considering the use of Enbrel in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes.
I fase 3-forsøgene med reumatoid artrit, psoriasisartrit og ankyloserende spondylitis blev der ikke observeret nogen overordnede forskelle i bivirkninger, alvorlige bivirknnger og alvorlige infektioner hos patienter over 65 år, som fik Enbrel, sammenlignet med yngre patienter.
In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received Enbrel were observed compared with younger patients.
Den procentdel af patienter, som udviklede nye positive anti-dobbeltstrengede DNA-antistoffer, var også højere ved radioimmunbestemmelse (15 % af patienter, der blev behandlet med Enbrel, sammenlignet med 4 % af de patienter, der fik placebo) og ved Crithidia liciliae-bestemmelse (3 % af patienter, der blev behandlet med Enbrel sammenlignet med ingen af de patienter, der fik placebo).
The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with Enbrel compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with Enbrel compared to none of placebo-treated patients).
Hvis der kommer lidt blødning på injektionsstedet, kan du trykke et stykke vat eller gaze mod injektionsstedet i 10 sekunder.
If you notice a spot of blood at the injection site, you should press the cotton ball or gauze over the injection site for 10 seconds.
Enbrel må ikke anvendes, hvis ikke alt pulveret i glasset er opløst inden for 10 minutter.
Enbrel should not be used if all the powder in the vial is not dissolved within 10 minutes.
Tag pennen op og fjern den hvide nålehætte ved at trække den lige af (se billede 3).
Pick up the pen, and remove the white needle cap by pulling it straight off (see Diagram 3).
Der er i meget sjældne tilfælde rapporteret om Merkelcellekarcinom postmarketing hos patienter behandlet med Enbrel.
Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel.
I studie 3 opretholdt hovedparten af de patienter (77 %), som initialt blev randomiseret til 50 mg to gange om ugen og som fik nedsat deres Enbrel dosis til 25 mg to gange om ugen efter 12 uger, deres PASI 75respons til uge 36.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their Enbrel dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
Hvert 10 mg hætteglas Enbrel bør kun anvendes én gang til en enkelt patient og resterende indhold i hætteglasset bør bortkastes.
Each vial of Enbrel 10 mg should be used on a single occasion in a single patient, and the remainder of the vial should be discarded.
Ikke kendt (kan ikke estimeres ud fra forhåndenvær ende data)
(<1/10,000); not known (cannot be estimated from the available data).
Nedenstående vejledning forklarer, hvordan man tilbereder og injicerer Enbrel.
The following instructions explain how to prepare and inject Enbrel.
Trin 1: Forberedelse til injektion af Enbrel Trin 2: Valg af injektionssted Trin 3: Injektion af Enbrel-injektionsvæsken Trin 4: Bortskaffelse af den brugte MYCLIC pen
Step 1: Preparing for an Enbrel injection Step 2: Choosing an injection site Step 3: Injecting the Enbrel solution Step 4: Disposing of the used MYCLIC pen
Ca. 15 % af de forsøgspersoner, der fik Enbrel, opnåede ACR 70 respons ved måned 3 og måned 6 sammenlignet med færre end 5 % af forsøgspersonerne i placebo gruppen.
Approximately 15% of subjects who received Enbrel achieved an ACR 70 response at month 3 and month 6 compared to fewer than 5% of subjects in the placebo arm.
Forberedelse af Enbrel dosis til injektion d.
Preparing the Enbrel dose for injection d.
Hvis der ikke er nogen effekt af Enbrel-behandlingen efter 12 uger, fortæller lægen dig måske, at behandlingen skal stoppes.
If Enbrel has no effect on your condition after 12 weeks, your doctor may tell you to stop taking this medicine.
Nogle forekom i løbet af et par uger efter start af behandling med Enbrel hos patienter, som har tilgrundliggende sygdomsforhold (for eksempel diabetes, hjertestop, patienthistorie med aktive eller kroniske infektioner) ud over reumatoid artrit (se pkt.
Some have occurred within a few weeks after initiating treatment with Enbrel in patients who have underlying conditions (e.g., diabetes, congestive heart failure, history of active or chronic infections) in addition to their rheumatoid arthritis (see section 4.4).
Tag ikke Enbrel:
Do not use Enbrel
Den andel af patienter, der fik behandling med Enbrel, og som udviklede anticardiolipin-antistoffer, steg i samme omfang som for patienter, der fik placebo.
The proportion of patients treated with Enbrel who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients.
Blandt patienter, som gennemførte studiets 24 måneders behandling, var ikke-progressionsraterne henholdsvis 78 %, 70 % og 62 %.
Among patients who completed a full 24 months of therapy in the study, the non-progression rates were 78%, 70%, and 61%, respectively.
• Fjern plastichætten fra Enbrel-hætteglasset.
• Remove the plastic cap from the Enbrel vial.
Efter 24 uger havde 56 % af patienterne i den Enbrel behandlede gruppe opnået PASI 75 sammenlignet med 5 % i den placebo behandlede gruppe.
At 24 weeks, 56% of patients in the Enbrel-treated group had achieved the PASI 75 compared to 5% of placebotreated patients.
Behandling med Enbrel resulterede i forbedret fysisk funktion i den dobbeltblinde studieperiode, og denne bedring blev fastholdt i det forlængede studie på op til 2 år.
Enbrel treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years.
I den dobbeltblindede periode fik patienterne Enbrel 50 mg ugentligt eller placebo i 12 uger.
In the double-blind period, patients received Enbrel 50 mg weekly or placebo for 12 weeks.
ACR 20 og 50 respons var højere hos patienter, der blev behandlet med Enbrel, ved 3 og 6 måneder, end hos patienter behandlet med placebo (ACR 20: Enbrel 62 % og 59 %, placebo 23 % og 11 % ved henholdsvis 3 og 6 måneder; ACR 50: Enbrel 41 % og 40 %, placebo 8 % og 5 % ved henholdsvis 3 og 6 måneder; p<0,01 Enbrel versus placebo ved alle tidspunkter for både ACR 20 og ACR 50 respons.
ACR 20 and 50 responses were higher in patients treated with Enbrel at 3 and 6 months than in patients treated with placebo (ACR 20: Enbrel 62% and 59%, placebo 23% and 11% at 3 and 6 months respectively: ACR 50: Enbrel 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p<0.01 Enbrel vs placebo at all timepoints for both ACR 20 and ACR 50 responses).
Nogle børne- og teenage-patienter, som har fået Enbrel eller anden medicin, der virker på samme måde som Enbrel, har udviklet kræft, inkl.
Some children and teenage patients who have received Enbrel or other medicines that work the same way as Enbrel have developed cancers, including unusual types, which sometimes resulted in death.
Bevæg hætteglasset med cirkelformede bevægelser et par gange, således at pulveret opløses (se billede 6).
Gently move the vial in circles a few times, to dissolve the powder (see Diagram 6).
I et studie med 49 voksne patienter med reumatoid artrit, som blev behandlet med Enbrel, var der ingen tegn på nedsættelse af tardiv overfølsomhed, nedsættelse af immunoglobulinniveauer eller ændring i optællingen af effektorcellepopulationer.
In a study of 49 adult patients with rheumatoid arthritis treated with Enbrel, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations.
112 patienter blev randomiseret til at få 25 mg Enbrel (n = 57) eller placebo (n = 55) to gange om ugen i 24 uger.
One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of Enbrel (n=57) or placebo (n=55) twice a week for 24 weeks.
Patienter, der udvikler HBV-infektion, bør stoppe behandlingen med Enbrel og starte effektiv antiviral behandling med passende supportiv behandling.
In patients who develop HBV infection, Enbrel should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Generelt er anvendelse af Enbrel til børn under 6 år med plaque psoriasis ikke relevant.
There is generally no applicable use of Enbrel in children aged below 6 years in the indication plaque psoriasis.
Det er en alkoholserviet fra Enbrel-æsken eller et stykke gaze.
These include the alcohol swab from the Enbrel carton and a cotton ball or gauze.
Patienterne fik 0,8 mg/kg Enbrel (op til 50 mg) eller placebo en gang om ugen i 12 uger.
Patients received Enbrel 0.8 mg/kg (up to 50 mg) or placebo once weekly for 12 weeks.
Fortsat, varigt respons er set i op til 10 år i åbne, forlængede studier hos patienter, som fik Enbrel unden afbrydelse.
Continued durable responses have been seen for up to 10 years in open-label extension treatment trials when patients received Enbrel without interruption.
Forberedelse af Enbrel dosis til injektion
Preparing the Enbrel dose for injection
Sikkerhed og effekt ved brug af Enbrel til patienter med kroniske infektioner er ikke blevet vurderet.
The safety and efficacy of Enbrel in patients with chronic infections have not been evaluated.
Hvis du herved kommer til at presse væske tilbage i glasset, skal du langsomt trække stemplet ud for at trække væsken tilbage i sprøjten igen.
When you do this, if you accidentally push liquid back into the vial, slowly pull the plunger to draw the liquid back into the syringe.
Se venligst afsnit 5 vedrørende opbevaring af Enbrel.
Please see section 5 for instructions on how to store Enbrel.
• Lægen har ordineret Enbrel til et barn, som du har ansvar for.
• This medicine has been prescribed for a child in your care.
Tilsvarende blev også observeret signifikante fordele ved Enbrel monoterapi sammenlignet med methotrexat monoterapi efter 24 måneder.
Similarly, the significant advantages for Enbrel monotherapy compared with methotrexate monotherapy were also observed after 24 months.
Bemærk: Hvis du ikke kan injicere som beskrevet, skal du presse pennen fastere mod huden og trykke på den grå knap igen.
Note - If you are unable to start the injection as described, press the pen more firmly against your skin, then press the grey button again.
Inflammatorisk tarmsygdom (IBD) og uveitis hos patienter med juvenil idiopatisk artrit (JIA) Der har været rapporter om IBD og uveitis hos JIA-patienter, som behandles med Enbrel (se pkt.
Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA) There have been reports of IBD and uveitis in JIA patients being treated with Enbrel (see section 4.8).
Lægen kan beslutte at fortsætte med at kontrollere, om du eller barnet har infektioner, efter at du eller barnet er holdt op med at bruge Enbrel.
Your doctor may decide to continue to monitor you or the child for the presence of infections after you or the child stop using Enbrel.
I studier, hvor voksne patienter blev behandlet samtidig med Enbrel og anakinra, blev der observeret en større hyppighed af alvorlige infektioner sammenlignet med Enbrel alene, og 2 % af patienterne (3/139) udviklede neutropeni (absolut neutrofiltælling < 1000/mm
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count < 1000/mm3).
• Træk kanylen helt ud af hætteglasset.
• Pull the needle completely out of the vial.
Hos patienter med psoriasisartrit har Enbrel vist sig at forbedre den fysiske funktion og at reducere udviklingen af perifere ledskader, målt ved hjælp af røntgen, hos patienter med polyartikulære, symmetriske undertyper af sygdommen.
Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Hvis en eller flere af følgende reaktioner optræder, må du ikke injicere mere Enbrel.
If any of the following happen, do not inject more Enbrel.
I kontrollerede studier med patienter med plaque psoriasis-fik ca. 13.6 % af patienterne behandlet med Enbrel reaktioner på injektionsstedet i løbet af de første 12 ugers behandling sammenlignet med 3,4 % af patienterne behandlet med placebo.
In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with Enbrel developed injection site reactions compared with 3.4% of placebo-treated patients during the first 12 weeks of treatment.
• Placer Enbrel hætteglasset på en plan flade, f.eks. et bord, og stik kanylen lige ned igennem midten af hætteglassets grå prop (se billede 2).
• With the Enbrel vial upright on a flat surface, such as a table, insert the syringe needle straight down through the centre ring of the grey stopper of the vial (see Diagram 2).
Det vil hjælpe med til at reducere dannelse af luftbobler (se billede 5).
This will help reduce foaming (lots of bubbles) (see Diagram 5).
I løbet af en randomiseret aftrapningsperiode fik signifikant flere patienter, som var gen-randomiseret til placebo, sygdomstilbagefald (tab af PASI 75-respons) sammenlignet med patienter, som var genrandomiseret til Enbrel.
During a randomised withdrawal period, significantly more patients re-randomised to placebo experienced disease relapse (loss of PASI 75 response) compared with patients re-randomised to Enbrel.
Enbrel må normalt ikke bruges til behandling af polyartrit eller udvidet oligoartrit hos børn under 2 år, til behandling af børn med enthesitis-relateret artrit eller psoriatisartrit under 12 år, eller til behandling af psoriasis hos børn under 6 år.
Enbrel should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2 years, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12 years, or in children with psoriasis below the age of 6 years.
I det to-årige aktivt kontrollerede forsøg, hvor patienterne blev behandlet med enten Enbrel alene, methotrexat alene eller Enbrel i kombination med methotrexat, var antallet af alvorlige infektioner det samme i behandlingsgrupperne.
In the 2-year active-controlled study where patients were treated with either Enbrel alone, methotrexate alone or Enbrel in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
For patienter som fik 25 mg to gange om ugen igennem hele studiet, fortsatte PASI 75responset med at forbedres mellem uge 12 og 36.
For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
Desuden viste et studie, at barnet hyppigere havde medfødte misdannelser, når kvinden havde taget Enbrel under graviditeten, sammenlignet med kvinder, der ikke havde taget Enbrel eller andre tilsvarende lægemidler (TNF-antagonister) under graviditet.
In addition, one study found more birth defects when the mother had received Enbrel in pregnancy, compared with mothers who had not received Enbrel or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported.
Ved kombination af resultater fra kontrollerede kliniske forsøg blev der observeret flere tilfælde af NMSC hos patienter behandlet med Enbrel, specielt psoriasispatienter, sammenlignet med kontrolpatienterne.
Combining the results of controlled clinical trials, more cases of NMSC were observed in patients receiving Enbrel compared with control patients, particularly in patients with psoriasis.
Patientinformationskortet til patienter, der behandles med Enbrel, skal indeholde følgende hovedelementer:
The Patient's Alert Card should contain the following key elements for patients treated with Enbrel:
Efter den 12 uger lange dobbeltblinde behandlingsperiode fik alle patienter 0,8 mg/kg Enbrel (op til 50 mg) en gang om ugen i yderligere 24 uger.
After the 12-week double-blind treatment period, all patients received Enbrel 0.8 mg/kg (up to 50 mg) once weekly for additional 24 weeks.
I et studie af 48 ugers varighed med 211 børn i alderen 4 til 17 år med pædiatrisk plaque psoriasis var de indberettede bivirkninger de samme som dem, man havde set i tidligere studier hos voksne med plaque psoriasis.
In a 48-week study in 211 children aged 4 to 17 years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
Injektionen er færdig, når det andet klik lyder (eller efter at der er gået 10 sekunder) (se billede 6).
On hearing the second ‘click' (or, if you do not hear a second ‘click', after 10 seconds have passed), your injection will be complete (see Diagram 6).
Patienter i behandling med Enbrel bør få udleveret et eksemplar af 'Patientkort'.
Patients treated with Enbrel should be given the Patient Alert Card.
Se efter nålespidsen inde i propvinduet (se billede 3).
Look for the needle tip inside the stopper window (see Diagram 3).
Der har været sjældne rapporter om CNS-demyeliniseringslidelser hos patienter behandlet med Enbrel (se pkt.
There have been rare reports of CNS demyelinating disorders in patients treated with Enbrel (see section 4.8).
Lægen kan beslutte at fortsætte med at kontrollere, om barnet har infektioner, efter at barnet er holdt op med at bruge Enbrel.
Your doctor may decide to continue to monitor the child for the presence of infections after the child stops using Enbrel.
Effekten af Enbrel blev bedømt i et randomiseret, dobbeltblindt placebokontrolleret studie med 205 patienter med psoriasisartrit.
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
I kliniske studier af op til 12 måneders varighed med patienter i behandling med godkendte doser af etanercept var den kumulative incidens af anti-etanercept antistoffer ca. 6 % af patienterne med reumatoid artrit, 7,5 % af patienterne med psoriasisartrit, 2 % af patienterne med ankyloserende spondylitis, 7 % af patienterne med psoriasis, 9,7 % af patienterne med pædiatrisk psoriasis og 4,8 % af patienterne med juvenil, idiopatisk artrit.
In subjects treated with approved doses of etanercept in clinical trials for up to 12 months, cumulative rates of anti-etanercept antibodies were approximately 6% of subjects with rheumatoid arthritis, 7.5% of subjects with psoriatic arthritis, 2% of subjects with ankylosing spondylitis, 7% of subjects with psoriasis, 9.7% of subjects with paediatric psoriasis, and 4.8 % of subjects with juvenile idiopathic arthritis.
Antistoffer mod Enbrel
Antibodies to Enbrel
Behandling med Enbrel bør iværksættes og overvåges af specialister med erfaring i diagnosticering og behandling af reumatoid artrit, juvenil idiopatisk artrit, psoriasisartrit, ankyloserende spondylitis, nonradiografisk aksial spondylartrit, plaque psoriasis eller pædiatrisk plaque psoriasis.
Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.
Nedenstående vejledning forklarer, hvordan MYCLIC pennen bruges til injektion af Enbrel.
The instructions below explain how to use the MYCLIC pen to inject Enbrel.
Der er mulighed for, at TNF-antagonister, herunder Enbrel, kan påvirke patientens modstandsdygtighed over for infektioner og maligniteter, eftersom TNF formidler betændelse og modulerer celleimmunrespons.
The possibility exists for TNF-antagonists, including Enbrel, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.