natgillin/translations-raw huggingface dataset:
I den behandlingsfrie periode vendte symptomerne på psoriasis gradvist tilbage med en mediantid til sygdoms relapse på 3 måneder.
During the withdrawal period, symptoms of psoriasis gradually returned with a median time to disease relapse of 3 months.
Dannelse af autoantistof Behandling med LIFMIOR kan resultere i dannelse af autoimmunantistoffer (se pkt.
Autoantibody formation Treatment with LIFMIOR may result in the formation of autoimmune antibodies (see section 4.8).
• Du skal vælge et nyt sted for hver ny injektion.
• A different site should be used for each new injection.
Etanercept passerer placenta og er påvist i serum hos spædbørn født af kvinder, der er blevet behandlet med LIFMIOR under graviditeten.
Etanercept crosses the placenta and has been detected in the serum of infants born to female patients treated with LIFMIOR during pregnancy.
Autoimmun hepatitis*
Autoimmune hepatitis*
LIFMIOR skal anvendes med forsigtighed til patienter med en anamnese med hepatitis C.
LIFMIOR should be used with caution in patients with a history of hepatitis C.
Etanercept er et humant tumornekrosefaktorreceptor p75 Fc-fusionsprotein, som er fremstillet ved rekombinant dna-teknologi i et mammalt ekspressionssystem fra kinesiske hamstres ovarier (CHO).
Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian expression system.
Ankyloserende spondylitis Respons
Ankylosing Spondylitis Response
• Efter at have ventet ca. 15-30 minutter på at injektionsvæsken i pennen har opnået stuetemperatur, skal du vaske hænder med vand og sæbe.
After waiting approximately 15-30 minutes for the solution in the pen to warm to room temperature, wash your hands with soap and water.
Voksne patienter fik testet serumprøver for autoantistoffer på flere tidspunkter.
Adult patients had serum samples tested for autoantibodies at multiple timepoints.
For at undgå at nålen i pennen bliver beskadiget, må den hvide nålehætte ikke bøjes eller vrides, når den tages af, og du må ikke sætte den på igen, når først den er taget af.
To avoid damaging the needle inside the pen, do not bend the white needle cap while you are removing it, and do not re-attach it once it has been removed.
Da immunglobuliner lige som mange andre lægemidler kan udskilles i human mælk, skal der tages en beslutning om, hvorvidt amning skal ophøre, eller brugen af LIFMIOR skal ophøre under amning, idet fordelen ved amning for barnet og fordelen ved behandlingen af kvinden tages i betragtning.
Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision must be made whether to discontinue breast-feeding or to discontinue LIFMIOR therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Alle underområder i SHT'et blev forbedret hos patienter, der var behandlet med LIFMIOR, ved 3 og 6 måneder sammenlignet med kontrolpersonerne.
All subdomains of the HAQ were improved in patients treated with LIFMIOR compared to controls at 3 and 6 months.
Denne kombination har ikke vist øget klinisk udbytte.
This combination has not demonstrated increased clinical benefit.
En lille hulning vil kunne ses i huden (se billede 4).
A slight depression in the skin will be seen (see Diagram 4).
• Fjern papirbagsiden fra adapteræsken.
• Remove the paper backing from the vial adaptor package.
Behandling af voksne med svær nonradiografisk aksial spondylartrit med objektive tegn på inflammation indikeret ved forhøjet C-reaktivt protein (CRP) og/eller magnetisk resonans scanning (MRI), der har vist utilstrækkeligt respons på nonsteroide antiinflammatoriske lægemidler (NSAID).
Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs).
I kliniske studier resulterede samtidig administration af abatacept og LIFMIOR i et øget antal tilfælde af alvorlige bivirkninger.
In clinical studies, concurrent administration of abatacept and LIFMIOR resulted in increased incidences of serious adverse events.
Der er ikke foretaget studier om indflydelsen på evnen til at føre motorkøretøj eller betjene maskiner.
No studies on the effects on the ability to drive and use machines have been performed.
Patienter, som ”ikke responderer” er defineret ved utilstrækkeligt respons (PASI<50 eller PGA mindre end god) eller forværring af sygdommen under behandling med mindst én af de tre systemiske behandlinger i tilstrækkelige doser og af tilstrækkelig varighed for at opnå respons.
Patients who “failed to respond to” in the target population is defined by insufficient response (PASI<50 or PGA less than good), or worsening of the disease while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the three major systemic therapies as available.
Hvis LIFMIOR ikke har nogen virkning på barnets tilstand efter 12 uger, kan lægen fortælle dig, at behandlingen stoppes.
If LIFMIOR has no effect on the child's condition after 12 weeks, your doctor may tell you to stop using this medicine.
Sjældne tilfælde af pancytopeni og meget sjældne tilfælde af aplastisk anæmi, nogle med dødeligt udfald, er rapporteret hos patienter i behandling med LIFMIOR.
Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with LIFMIOR.
Hvis en eller flere af følgende reaktioner optræder hos barnet, må du ikke give barnet mere LIFMIOR.
If any of the following happen to the child, do not give the child more LIFMIOR.
Ved afslutningen af det dobbeltblinde studie kunne patienterne indgå i et langtids-, åbent, forlænget studie med en samlet varighed på op til 2 år.
At the end of the double-blind study, patients could enter a long-term open-label extension study for a total duration of up to 2 years.
LIFMIOR anbefales ikke til behandling af Wegeners granulomatose.
LIFMIOR is not recommended for the treatment of Wegener's granulomatosis.
Ryst ikke pennen.
Do not shake the pen.
Det primære slutmål for effekt var i alle fire studier antallet af patienter i hver gruppe, som opnåede PASI 75 (dvs mindst 75 % forbedring i Psorisis Arealet og på Severity Index scoren i forhold til baseline) efter 12 ugers behandling.
The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i.e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
LIFMIOR skal kasseres, hvis det ikke er brugt inden for 4 uger efter, at det er taget ud af køleskabet.
LIFMIOR should be discarded if not used within four weeks after removal from the refrigerator.
LIFMIOR ordineres også til behandling af følgende sygdomme hos børn og unge:
LIFMIOR is also prescribed for the treatment of the following diseases in children and adolescents
• til følgende typer af juvenil idiopatisk artrit (børnegigt), hvor behandling med methotrexat har været utilstrækkelig eller ikke kan anvendes:
• For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable for them:
Effekten af LIFMIOR versus andre systemiske behandlinger til patienter med moderat til svær psorisis (responderende på andre systemiske behandlinger) er endnu ikke evalueret i direkte sammenlignende studier med LIFMIOR overfor andre systemiske behandlinger.
The efficacy of LIFMIOR versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing LIFMIOR with other systemic therapies.
Nogle forekom i løbet af et par uger efter start af behandling med LIFMIOR 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 LIFMIOR 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).
• Opsvulmen af ansigt, hals, hænder eller fødder
• Swelling of the face, throat, hands, or feet
Patienter, som er signifikant udsat for varicellavirus, bør midlertidigt stoppe behandlingen med LIFMIOR, og profylaktisk behandling med varicella zoster immunglobulin bør overvejes.
Patients with a significant exposure to varicella virus should temporarily discontinue LIFMIOR therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin.
• Lægen eller hans/hendes assistent skal have instrueret dig i den korrekte mængde injektionsvæske, der skal trækkes ud af hætteglasset.
• The doctor or his/her assistant should have instructed you on the proper amount of solution to be withdrawn from the vial.
Hvis du er bekymret over opløsningens udseende, skal du kontakte dit apotek for assistance.
If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.
Fra anden dels begyndelse var mediantiden til sygdomsopblussen  116 dage for patienter, som fik LIFMIOR, og 28 dage for patienter, som fik placebo.
From the start of part 2, the median time to flare was ≥ 116 days for patients who received LIFMIOR and 28 days for patients who received placebo.
• hvis du eller barnet lider af nogen form for infektion.
• if you or the child have an infection of any kind.
Forekomsten var dog sjælden, og opfølgningstiden for placebopatienter var kortere end for patienter, der fik TNFantagonistbehandling.
However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.
Hvis du har glemt at injicere LIFMIOR
If you forget to inject LIFMIOR
Injicer opløsningen efter den har opnået stuetemperatur (15-30 minutter efter produktet er taget ud af køleskabet).
Inject the solution after it has reached room temperature (15 to 30 minutes after taking the product from the refrigerator).
Kræft kan påvirke hele kroppen, herunder hud og blod, og mulige tegn på kræft afhænger af typen og lokalisering i kroppen.
• Signs of cancers: Cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer.
Efter subkutan administration til diegivende rotter blev etanercept udskilt i mælken og påvist i serum hos ungerne.
In lactating rats following subcutaneous administration, etanercept was excreted in the milk and detected in the serum of pups.
Langtidssikkerhedsdata for LIFMIOR som monoterapi (n=103), LIFMIOR plus methotrexat (n=294) eller methotrexat som monoterapi (n=197) blev vurderet i op til 3 år i et register med 594 børn i alderen 2-18 år med juvenil idiopatisk artrit; heraf var 39 i alderen 2-3 år.
Long-term safety of LIFMIOR monotherapy (n=103), LIFMIOR plus methotrexate (n=294), or methotrexate monotherapy (n=197) were assessed for up to 3 years in a registry of 594 children aged 2 to 18 years with juvenile idiopathic arthritis, 39 of whom were 2 to 3 years of age.
Opløsningen må ikke bruges, hvis den er misfarvet eller uklar, eller hvis den indeholder andre partikler end dem, der er beskrevet ovenfor.
Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present.
Der er ingen kendt modgift mod LIFMIOR.
There is no known antidote to LIFMIOR.
I et fase II randomiseret, placebokontrolleret forsøg med 48 indlagte patienter behandlet med LIFMIOR eller placebo for moderat til svær alkoholisk hepatitis var LIFMIOR ikke effektivt, og mortaliteten for patienter behandlet med LIFMIOR var signifikant højere efter 6 måneder.
In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with LIFMIOR or placebo for moderate to severe alcoholic hepatitis, LIFMIOR was not efficacious, and the mortality rate in patients treated with LIFMIOR was significantly higher after 6 months.
Samtidig administration af LIFMIOR og anakinra er blevet forbundet med en øget risiko for alvorlige infektioner og neutropeni sammenlignet med LIFMIOR alene.
Concurrent administration of LIFMIOR and anakinra has been associated with an increased risk of serious infections and neutropenia compared to LIFMIOR alone.
Kontroller injektionsvæsken i pennen ved at se gennem inspektionsvinduet.
Inspect the solution in the pen by looking through the clear inspection window.
Der er ikke tilstrækkeligt bevis for effekten af LIFMIOR hos patienter med ankyloserende spondylitislignende og artritis mutilans psoriasis artropatier på grund af det lille antal patienter, der er undersøgt.
There is insufficient evidence of the efficacy of LIFMIOR in patients with ankylosing spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied.
• Inspektionsvinduet i pennen skal nu være helt lilla som tegn på at injektionen er udført korrekt (se billede 8).
The pen's inspection window should now be completely purple, confirming that the dose has been injected correctly (see Diagram 8).
Hvis barnet har nogen af ovennævnte symptomer, kan han/hun have en allergisk reaktion over for LIFMIOR, og du skal derfor søge øjeblikkelig lægehjælp.
If the child has any of the above symptoms he/she may be having an allergic reaction to LIFMIOR, so you should seek immediate medical attention.
LIFMIOR var signifikant bedre end placebo på alle mål for sygdomsaktivitet (p<0,001), og responset var det samme med og uden samtidig methotrexat behandling.
LIFMIOR was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy.
• Psoriasisgigt hos patienter fra 12 år.
• Psoriatic arthritis in patients from the age of 12 years
Patienter, der udvikler HBV-infektion, bør stoppe behandlingen med LIFMIOR og starte effektiv antiviral behandling med passende supportiv behandling.
In patients who develop HBV infection, LIFMIOR should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
• hvis du eller barnet har eller er i risiko for at udvikle en alvorlig blodinfektion kaldet sepsis (blodforgiftning).
• if you or the child have, or are at risk of developing a serious blood infection called sepsis.
Sikkerheden på lang sigt ved LIFMIORbehandling i kombination med andre sygdomsmodificerende antireumatiske lægemidler (DMARDs) er ikke fastslået.
The long-term safety of LIFMIOR in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established.
• Nogle patienter i behandling med LIFMIOR har udviklet hudkræft.
Some patients receiving LIFMIOR have developed skin cancers.
• Fjern plastikhætten fra LIFMIOR-hætteglasset (se billede 1).
• Remove the plastic cap from the LIFMIOR vial (see Diagram 1).
Behandling med LIFMIOR kan medføre genopblussen af hepatitis B hos patienter, som tidligere har haft hepatitis B-infektion.
Treatment with LIFMIOR may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus.
Kvinder i LIFMIOR-behandling må ikke amme, da LIFMIOR passerer over i mælken.
Women using LIFMIOR should not breast-feed, since LIFMIOR passes into human breast milk.
Måned 12
Month 12
Det kan ikke udelukkes, at der er en risiko for udvikling af maligniteter hos børn og yngre voksne behandlet med TNF-antagonister.
A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
1 LIFMIOR hætteglas
1 LIFMIOR vial
Ved baseline havde patienterne en moderat grad af handicap, med en gennemsnitlig score på 1,4 til 1,5 ud fra deres spørgeskema om helbredstilstand (SHT).
At baseline, patients had a moderate degree of disability, with mean HAQ scores of 1.4 to 1.5.
Patienter bør testes for HBV-infektion inden opstart af behandling med LIFMIOR.
Patients should be tested for HBV infection before initiating treatment with LIFMIOR.
Forhøjede TNF-niveauer er også fundet i synovia og psoriasis plaque hos patienter med psoriasisartrit og i serum og synovialt væv hos patienter med ankyloserende spondylitis.
Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
• Din læge vil give dig et 'Patientkort', som indeholder vigtig sikkerhedsinformation, som du skal være opmærksom på før og under behandlingen med LIFMIOR.
• Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with LIFMIOR.
Blandt de patienter, der fik LIFMIOR, viste de kliniske reaktioner sig generelt inden for 1-2 uger efter påbegyndelse af behandlingen og skete næsten altid senest måned 3.
Among patients receiving LIFMIOR, the clinical responses generally appeared within 1 to 2 weeks after initiation of therapy and nearly always occurred by 3 months.
En patient med reumatoid artrit tog ved en fejltagelse 62 mg LIFMIOR subkutant to gange om ugen i tre uger uden at registrere uønskede virkninger.
One rheumatoid arthritis patient mistakenly self-administered 62 mg LIFMIOR subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
I studiet blev 215 voksne patienter (modificeret intent-to-treat-population) i alderen 18 til 49 år med aktiv nrAxSpa, defineret som de patienter, der opfyldte ASAS-klassifikationskriterierne for aksial spondylartrit, men ikke opfyldte de modificerede New York-kriterier for AS, vurderet.
The study evaluated 215 adult patients (modified intent-to-treat population) with active nr-AxSpa (18 to 49 years of age), defined as those patients meeting the ASAS classification criteria of axial spondyloarthritis but did not meet the modified New York criteria for AS.
Dette omfatter rapporter om reaktivering af hepatitis B hos patienter, som var anti-HBc-positive, men HBsAg-negative.
This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative.
Pakningsstørrelser og yderligere oplysninger 7.
Contents of the pack and other information 7.
Levende vacciner bør ikke gives samtidigt med LIFMIOR.
Live vaccines should not be given concurrently with LIFMIOR.
I de dobbeltblinde og åbne studier med psoriasis arthritis indberettede én patient en alvorlig infektion (pneumoni).
In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia).
Effektrespons i placebokontrolleret nr-AxSpa-studie: Procentdel af patienter, der opnåede endepunkterne Dobbeltblindet klinisk respons i uge 12
Efficacy Response in Placebo-Controlled nr-AxSpa Study: Percent of Patients Achieving Endpoints Double-Blind Clinical Responses at Week 12
LIFMIOR ordineres til behandling af følgende sygdomme hos børn og unge:
LIFMIOR is prescribed for the treatment of the following diseases in children and adolescents
Hvis du skal injicere dig selv, skal du ikke anvende bagsiden af overarmen.
If you are self injecting, you should not use the outer area of the upper arms.
Andelen af patienter, som udvikler antistoffer mod etanercept i langtidsstudier (af op til 3,5 års varighed), stiger over tid som forventet.
The proportion of subjects who developed antibodies to etanercept in longer-term trials (of up to 3.5 years) increases over time, as expected.
I uge 104 var der 8 patienter, som havde forværring til en bilateral score grad 2 ved røntgen af rygsøjlen jf. den modificerede NewYork Radiological Grade, hvilket tyder på axial spondylartropati.
At week 104, 8 subjects had progressed to a score of bilateral Grade 2 on spinal X-ray according to the modified New York Radiological Grade, indicative of axial spondyloarthropathy.
• Mens pennen presses fast mod huden for at sikre, at sikkerhedshætten er presset helt ind i pennen, skal du trykke med tommelfingeren midt på den grønne aktiveringsknap øverst på pennen for at begynde injektionen (se billede 5).
Whilst pushing the pen firmly against the skin to ensure that the needle safety shield is fully depressed inside the pen, press the centre of the green button on top of the pen with your thumb to start the injection (see Diagram 5).
Lægen kan dog beslutte en anden hyppighed for injicering af LIFMIOR.
However, your doctor may determine an alternative frequency at which to inject LIFMIOR.
Methotrexat (n = 228)
Methotrexate (n = 228)
Blandt patienter, som gennemførte studiets 24 måneders behandling, var ikke-progressionsraterne henholdsvis 78 %, 70 % og 61 %.
Among patients who completed a full 24 months of therapy in the study, the non-progression rates were 78%, 70%, and 61%, respectively.
Fortæl lægen, hvis barnet får mavekramper eller mavesmerter, diarré, vægttab eller blod i afføringen.
Tell the doctor if the child develops any abdominal cramps and pain, diarrhoea, weight loss or blood in the stool.
Alternativt kan 50 mg indgives en gang om ugen, hvilket har vist sig at være sikkert og effektivt (se pkt.
Alternatively, 50 mg administered once weekly has been shown to be safe and effective (see section 5.1).
• Kraftigt udslæt, kløe eller nældefeber (hævede pletter af rød eller bleg hud, som ofte klør).
• Severe rash, itching, or hives (elevated patches of red or pale skin that often itch)
Der blev besvaret et spørgeskema om helbredstilstand (SHT), omfattende handicap, vitalitet, mentalhygiejne, generel sundhedstilstand og helbredsstatus for arthritis-afhængige underområder hver 3. måned under forsøget.
A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3 months during the trial.
Gruppen af patienter i behandling med LIFMIOR i kombination med methotrexat havde signifikant højere ACR 20, ACR 50, ACR 70 respons og forbedring af DAS og HAQ score ved både 24 og 52 uger end patienterne i hver af enkeltterapi grupperne (resultater vises neden for).
Patients in the LIFMIOR in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Ikke-melanom hudkræft* (se pkt.
Non-melanoma skin cancers* (see section 4.4)
Hvis diagnosen aktiv tuberkulose stilles, må behandling med LIFMIOR ikke påbegyndes.
If active tuberculosis is diagnosed, LIFMIOR therapy must not be initiated.
Etanercept udskilles i human mælk efter subkutan administration.
Etanercept has been reported to be excreted in human milk following subcutaneous administration.
Scoren på invaliditetsindekset blev signifikant forbedret på alle tidspunkter hos patienter med psoriasisartrit i behandling med LIFMIOR i sammenligning med placebo (p<0,001).
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with LIFMIOR, relative to placebo (p < 0.001).
Efter markedsføring er der rapporteret om maligniteter, heraf nogle letale, hos børn, unge og unge voksne (op til 22 år), der er behandlet med TNF-antagonister (start på behandling ≤ 18 år), herunder LIFMIOR.
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including LIFMIOR, in the postmarketing setting.
Fortæl det straks til lægen eller tag på skadesstuen på det nærmeste hospital.
Tell your doctor immediately, or go to the casualty department at your nearest hospital.
• Hold hætteglasset lodret på den plane overflade og skub stemplet MEGET LANGSOMT ind, indtil al solvens er i hætteglasset.
• While holding the vial upright on the flat surface, push the plunger VERY SLOWLY until all the solvent is in the vial.
Interstitiel lungesygdom (herunder pneumonitis og lungefibrose)*
Interstitial lung disease (including pneumonitis and pulmonary fibrosis)*