natgillin/translations-raw huggingface dataset:
Alvorlige infektioner (inklusive lungebetændelse, cellulitis, septisk arthritis, sepsis) *
Infections (including upper respiratory tract infections, bronchitis, cystitis, skin infections)* Uncommon:
8 Sjælden:
Rare:
Tuberkulose, opportunistiske infektioner (herunder invasive svampeinfektioner samt protozoale, bakterielle og atypiske mykobakterielle infektioner) *
Serious infections (including pneumonia, cellulitis, septic arthritis, sepsis)* Tuberculosis, opportunistic infections (including invasive fungal, protozoal, bacterial and atypical mycobacterial infections)*
Sygdomme i blod og lymfesystem:
Blood and lymphatic system disorders:
Trombocytopeni Anæmi, leukopeni, neutropeni, pancytopeni * Aplastisk anæmi *
Thrombocytopenia Anaemia, leukopenia, neutropenia, pancytopenia* Aplastic anaemia*
Sygdomme i immunsystemet:
Immune system disorders:
Makrofag- aktiverings- syndrom *, anti- neutrofil cytoplasmisk antistof- positiv vaskulitis
Allergic reactions (see Skin and subcutaneous tissue disorders), autoantibody formation* Serious allergic/ anaphylactic reactions (including angioedema, bronchospasm) Macrophage activation syndrome*, anti-neutrophilic cytoplasmic antibody positive vasculitis
Kramper CNS demyeliseringstilfælde som antyder multipel sclerose eller lokaliserede demyeliseringsforhold som for eksempel optisk neuritis og transversel myelitis (se afsnit 4. 4)
Seizures CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions such as optic neuritis and transverse myelitis (see section 4.4)
Interstitiel lungesygdom (herunder pneumonitis og pulmonal fibrose) *
Interstitial lung disease (including pneumonitis and pulmonary fibrosis)*
Sygdomme i lever og galdeveje:
Hepatobiliary disorders:
Forhøjede leverenzymer
Elevated liver enzymes
Sygdomme i hud og subkutane væv
10 Skin and subcutaneous tissue disorders:
Pruritus, Angioødem, urticaria, udslæt, psoriasisagtigt udslæt, psoriasis (herunder nyt anfald og pustuløs, primært håndflader og fodsåler)
Pruritus Angioedema, urticaria, rash, psoriasiform rash, psoriasis (including new onset and pustular, primarily palms & soles)
Kutan vaskulitis (incl. leucocytoklastisk vaskulitis), Stevens- Johnson syndrom, erythema multiforme
Cutaneous vasculitis (including leukocytoclastic vasculitis), Stevens-Johnson syndrome, erythema multiforme
Sygdomme i bevægeapparatet, bindevæv og knogler
Musculoskeletal, connective tissue and bone disorders:
Subaktiv kutan lupus erythematosus, diskoid lupus erythematosus, lupus - lignende syndrom
Subacute cutaneous lupus erythematosus, discoid lupus erythematosus, lupus-like syndrome
Almindelige sygdomme og forhold omkring administrationsstedet:
General disorders and administration site conditions:
Reaktioner på injektionsstedet (herunder blødning, blå mærker, erytem, kløe, smerte, hævelse) *
Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)* Common:
Sygdomme vedrørende hjertet:
Cardiac disorders:
Der er rapporteret om forværring af kongestiv hjerteinsufficiens (se afsnit 4. 4)
There have been reports of worsening of congestive heart failure (see section 4.4).
9 * se Yderligere information, nedenfor.
*see Additional information, below.
Alvorlige bivirkninger rapporteret i kliniske forsøg
Serious adverse events reported in clinical trials
Blandt patienter med reumatoid artrit, psoriasis artrit, ankyloserende spondylitis og plaque psoriasis i placebokontrollerede, aktivt- kontrollerede og åbne forsøg med Enbrel, indbefattede de rapporterede alvorlige bivirkninger maligniteter (se nedenfor), astma, infektioner (se nedenfor), hjerteinsufficiens, hjerteinfarkt, myocardial iskæmi, brystsmerte, besvimelsesanfald, cerebral iskæmi, hypertension, hypotension, galdeblærebetændelse, bugspytkirtelbetændelse, gastrointestinal blødning, bursitis, forvirring, depression, dyspnø, abnorm opheling, renal insufficiens, nyresten, dyb venetrombose, lungeemboli, membranøs glomerulonephropathi, polymyositis, thrombophlebitis, leverskade, leukopeni, lammelse, paræstesi, vertigo, allergisk alveolitis, angioødem, scleritis, knoglefraktur, lymfeadenopati, ulcerøs colitis, intestinal obstruktion, eosinofili, hæmaturi og sarkoidosis.
Among rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis patients in placebo-controlled, active-controlled, and open-label trials of Enbrel, serious adverse events reported included malignancies (see below), asthma, infections (see below), heart failure, myocardial infarction, myocardial ischaemia, chest pain, syncope, cerebral ischaemia, hypertension, hypotension, cholecystitis, pancreatitis, gastrointestinal haemorrhage, bursitis, confusion, depression, dyspnoea, abnormal healing, renal insufficiency, kidney calculus, deep vein thrombosis, pulmonary embolism, membranous glomerulonephropathy, polymyositis, thrombophlebitis, liver damage, leucopenia, paresis, paresthesia, vertigo, allergic alveolitis, angioedema, scleritis, bone fracture, lymphadenopathy, ulcerative colitis, intestinal obstruction, eosinophilia, haematuria, and sarcoidosis.
6 år, inklusiv 231 patienter behandlet med Enbrel i kombination med methotrexat i det toårige aktivt kontrollerede forsøg.
One hundred and twenty-nine new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with Enbrel for up to approximately 6 years, including 231 patients treated with Enbrel in combination with methotrexate in the 2-year active-controlled study.
2 års varighed omfattende 240 patienter med psoriasis artrit behandlet med Enbrel.
A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 Enbrel-treated psoriatic arthritis patients.
I kliniske undersøgelser af mere end 2 års varighed med 351 patienter med ankyloserende spondylitis blev der rapporteret om 6 maligniteter hos patienter behandlet med Enbrel.
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in Enbrel-treated patients.
I dobbeltblinde og åbne undersøgelser i op til 15 måneders varighed omfattende 1. 261 patienter blev der rapporteret om 23 maligniteter hos patienter med plaque psorisis behandlet med Enbrel.
Twenty-three malignancies were reported in plaque psoriasis patients treated with Enbrel in double-blind and open-label studies of up to 15 months involving 1,261 Enbrel-treated patients.
Der blev rapporteret om ialt 15 tilfælde af lymfom hos 5. 966 patienter behandlet med Enbrel i kliniske undersøgelser omfattende reumatoid artrit, psoriasis artrit, ankyloserende spondylitis og psoriasis.
11 There were a total of 15 lymphomas reported in 5,966 patients treated with Enbrel in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials.
Rapporter om forskellige maligniteter (inkl. bryst - og lungecarcinom og lymfom), er blevet modtaget i postmarketingperioden (se afsnit 4. 4).
Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the postmarketing period (see section 4.4).
Sammenlignet med placebo, forekom der en betydeligt højere procentdel af reaktioner på injektionsstedet blandt patienter med reumatiske sygdomme, som blev behandlet med Enbrel (36% over for 9%).
9%).
3 til 5 dage.
Mean duration was approximately 3 to 5 days.
14, 5% af patienterne behandlet med Enbrel reaktioner på injektionsstedet i løbet af de første 12 ugers behandling sammenlignet med 5, 2% af patienterne behandlet med placebo.
In controlled trials in patients with plaque psoriasis, approximately 14.5% of patients treated with Enbrel developed injection site reactions compared with 5.2% of placebo-treated patients during the first 12 weeks of treatment.
I placebokontrollerede forsøg blev der ikke observeret nogen stigning i forekomsten af alvorlige infektioner (dødelige, livstruende, eller som kræver hospitalsindlæggelse eller intravenøs antibiotikabehandling).
In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life threatening, or requiring hospitalisation or intravenous antibiotics) was observed.
Alvorlige infektioner forekom hos 6, 3% af patienterne med reumatoid artrit, som blev behandlet med Enbrel i op til 48 måneder.
Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with Enbrel for up to 48 months.
10 (mistænkt), gastroenteritis, hepatitis B, herpes zoster, sår på benene, infektioner i munden, osteomyelitis, otitis, peritonitis, pneumoni, pyelonephritis, sepsis, septisk arthritis, sinusitis, hudinfektion, sår på huden, urinvejsinfektion, vasculitis og sårinfektion.
These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
I det toårige 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.
Der var ingen forskel i infektionsraten blandt patienter behandlet med Enbrel og patienter, som fik placebo mod plaque psoriasis, i placebokontrollerede undersøgelser af op til 24 ugers varighed.
There were no differences in rates of infection among patients treated with Enbrel and those treated with placebo for plaque psoriasis in placebo controlled trials of up to 24 weeks duration.
Blandt de alvorlige infektioner, som patienter i behandling med Enbrel kunne blive ramt af, var cellulitis, gastroenteritis, pneumoni, kolecystit, osteomyelitis, gastritis, appendicitis, streptokok- fasciitis, myositis, septisk chok, diverticulitis og absces.
Serious infections experienced by Enbrel-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
I de dobbeltblinde og åbne undersøgelser 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).
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 afsnit 4. 4).
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).
Der er rapporteret om opportunistiske infektioner i forbindelse med Enbrel, herunder invasive svampeinfektioner samt protozoale, bakterielle (herunder Listeria og Legionella) og atypiske mykobakterielle infektioner.
Opportunistic infections have been reported in association with Enbrel including invasive fungal, protozoal, bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
Data fra flere kliniske undersøgelser viste, at den samlede forekomst af opportunistiske infektioner var 0, 09% for de 15. 402 patienter, som blev behandlet med Enbrel.
In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received Enbrel.
Den eksponeringsjusterede hyppighed var 0, 06 tilfælde per 100 patientår.
In
Erfaringer efter markedsføring viser, at cirka halvdelen af alle indberetninger om opportunistiske infektioner på verdensplan var invasive svampeinfektioner.
12 postmarketing experience, approximately half of all of the case reports of opportunistic infections worldwide were invasive fungal infections.
De mest almindeligt indberettede invasive svampeinfektioner var forårsaget af Pneumocystis og Aspergillus.
The most commonly reported invasive fungal infections were Pneumocystis and Aspergillus.
Invasive svampeinfektioner stod for mere end halvdelen af dødsfaldene blandt patienter, som udviklede opportunistiske infektioner.
Invasive fungal infections accounted for more than half of the fatalities amongst patient who developed opportunistic infections.
4. 4).
The majority of the reports with a fatal outcome were in patients with Pneumocystis pneumonia, unspecified systemic fungal infections, and aspergillosis (see section 4.4).
Af de patienter med reumatoid artrit, som blev evalueret for antinukleare antistoffer (ANA), var den procentdel af patienter, som udviklede nye positive antinukleare antistoffer (> 1: 40), højere hos patienter, som modtog behandling med Enbrel (11%), end hos patienter med placebo- behandling (5%).
Of the rheumatoid arthritis patients evaluated for antinuclear antibodies (ANA), the percentage of patients who developed new positive ANA ( 1:40) was higher in patients treated with Enbrel (11%) than in placebo-treated patients (5%).
Den procentdel af patienter, som udviklede nye positive anti- dobbeltstrengede DNA antistoffer, var også højere ved radioimmun - bestemmelse (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).
Den andel af patienter, der fik behandling med Enbrel, og som udviklede anticaridolipin- 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.
I postmarketingerfaring har der været rapporter om patienter, herunder reumatoid faktor positive patienter, som har udviklet andre autoantistoffer i forbindelse med udslæt som er kompatibel med subaktiv kutan lupus eller diskoid lupus ved klinisk præsentation og biopsi.
There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy.
Der har været postmarketingsrapporter om pancytopeni og aplastisk anæmi, hvoraf visse havde dødelig udgang (se afsnit 4. 4).
There have been postmarketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4).
11 Interstitiel lungesygdom
Interstitial lung disease
Der er efter markedsføring rapporteret om interstitiel lungesygdom (herunder pneumonitis og pulmonal fibrose), nogle med dødelig udgang.
There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Laboratorieundersøgelser
Laboratory evaluations
Baseret på resultaterne fra kliniske undersøgelser vil det normalt ikke være nødvendigt med specielle laboratorieundersøgelser i tillæg til omhyggelig medicinsk behandling og tilsyn med patienterne.
Based on the results of clinical studies, normally no special laboratory evaluations are necessary in addition to careful medical management and supervision of patients.
Samtidig behandling med Enbrel og anakinra
Concurrent Enbrel and anakinra treatment
I undersøgelser, 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/ mm3).
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).
En patient med neutropeni udviklede cellulitis, som svandt efter hospitalsindlæggelse (se afsnit 4. 4 og 4. 5).
While neutropenic, one patient developed cellulitis that resolved after hospitalisation (see sections 4.4 and 4.5).
Uønskede virkninger hos pædiatriske patienter med polyartikulær juvenil idiopatisk arthritis
Undesirable effects in paediatric patients with polyarticular juvenile idiopathic arthritis
Typen af infektioner, som blev observeret i kliniske undersøgelser med patienter med juvenil, idiopatisk artrit i alderen 2 til 18 år, var generelt milde til moderate og svarende til dem, som almindeligvis ses hos ambulante, pædiatriske populationer.
13 The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
Alvorlige rapporterede bivirkninger omfattede varicella med tegn og symptomer på aseptisk meningitis, som forsvandt under eftervirkninger (se også afsnit 4. 4), appendicit, gastroenteritis, depression/ personlighedsforstyrrelse, sår på huden, oesofagitis/ gastritis, gruppe A streptokok septisk chok, type 1 diabetes mellitus, samt infektion af bløddele eller post- operative sår.
Severe adverse events reported included varicella with signs and symptoms of aseptic meningitis, which resolved without sequelae (see also section 4.4), appendicitis, gastroenteritis, depression/ personality disorder, cutaneous ulcer, oesophagitis/ gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft tissue and post-operative wound infection.
I en undersøgelse med børn i alderen 4 til 17 år med juvenil, idiopatisk artrit fik 43 af 69 (62%) af børnene en infektion, mens de fik Enbrel i løbet af undersøgelsens 3 måneder (del 1, utilsløret), og hyppigheden og sværhedsgraden af infektioner var ens hos 58 patienter, som gennemførte 12 måneders utilsløret forlænget behandling.
In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving Enbrel during 3 months of the study (part 1 open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy.
Typerne og andelen af andre bivirkninger hos patienter med juvenil idiopatisk artrit var de samme som dem, man så i undersøgelser af Enbrel til voksne patienter med reumatoid artrit, og hovedparten var milde.
The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of Enbrel in adult patients with rheumatoid arthritis, and the majority were mild.
Disse omfattede hovedpine (19% af patienterne, 1, 7 forekomst pr. patientår), kvalme (9%, 1, 0 forekomst pr. patientår), abdominal smerte (19%, 0, 74 forekomst pr. patientår), og opkastning (13%, 0, 74 forekomst pr. patientår).
These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
I kliniske undersøgelser omkring juvenil idiopatisk atrit var der 4 indberetninger om makrofag - aktiverings- syndrom.
There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
Uønskede virkninger hos pædiatriske patienter med plaque psoriasis I en undersøgelse 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 undersøgelser 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.
Den største dosis, der er blevet evalueret, var en intravenøs belastningsdosis på 32 mg/ m2 efterfulgt af subkutane doser på 16 mg/ m2, indgivet to gange ugentligt.
The highest dose level evaluated has been an intravenous loading dose of 32 mg/ m2 followed by subcutaneous doses of 16 mg/ m2 administered twice weekly.
En patient med reumatoid artrit tog ved en fejltagelse 62 mg Enbrel subkutant to gange om ugen i tre uger uden at registrere uønskede virkninger.
One rheumatoid arthritis patient mistakenly self- administered 62 mg Enbrel subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
Tumornekrosefaktor- alfa (TNF- α) hæmmere.
Tumor Necrosis Factor alpha (TNF- α) inhibitors.
Forhøjede TNF- niveauer er også fundet i synovia og psoriasis plaque hos patienter med psoriasis artrit 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.
Ved plaque psoriasis fører infiltration med inflammatoriske celler, inklusiv T- celler, til forhøjede TNF niveauer i psoriasis læsionerne sammenlignet med niveauerne i ikke- angrebet hud.
In plaque psoriasis, infiltration by inflammatory cells including T-cells leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Etanercept er en kompetitiv inhibitor af TNF- binding til celleoverfladereceptorer og hæmmer dermed TNF’ s biologiske aktivitet.
Etanercept is a competitive inhibitor of TNF-binding to its cell surface receptors and thereby inhibits the biological activity of TNF.
55- kilodalton (p55) og 75- kilodalton (p75) tumornekrosefaktorreceptorer (TNFR).
TNF and lymphotoxin are pro- inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
Begge TNF- receptorer eksisterer naturligt i membranbundne og opløselige former.
Both TNFRs exist naturally in membrane- bound and soluble forms.
Opløselige TNF- receptorer menes at regulere biologisk TNF- aktivitet.
Soluble TNFRs are thought to regulate TNF biological activity.
TNF og lymfotoksin eksisterer hovedsageligt som homotrimere, og deres biologiske aktivitet er afhængig af tværbinding af celleoverflade TNF- receptorer.
14 TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs.
Dimerisk opløselige receptorer som for eksempel etanercept har en højere affinitet for TNF end monomeriske receptorer og er betydeligt mere potent kompetitive inhibitorer af TNF- binding til cellereceptorerne.
Dimeric soluble receptors such as etanercept possess a higher affinity for TNF than monomeric receptors and are considerably more potent competitive inhibitors of TNF binding to its cellular receptors.
Derudover bibringer brugen af en immunoglobulin Fc- region som et fusionselement i opbyggelsen af en dimerisk receptor en længere serum- halveringstid.
In addition, use of an immunoglobulin Fc region as a fusion element in the construction of a dimeric receptor imparts a longer serum half-life.
Virkningsmekanisme Meget af den fælles patologi inden for reumatoid artrit og ankyloserende spondylitis og hudpatologien ved plaque psoriasis formidles af pro- inflammatoriske molekyler, som er bundet i et netværk, der kontrolleres af TNF.
Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis and skin pathology in plaque psoriasis is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF.