natgillin/translations-raw huggingface dataset:
75 Plaque psoriasis Behandling af voksne med moderat til svær plaque psoriasis, som har vist utilstrækkelig respons på, eller viste sig at være intolerante overfor, anden systemisk behandling inklusiv cyclosporin, methotrexat eller PUVA eller hvor den systemiske behandling inklusiv cyclosporin, methotrexat eller PUVA er kontraindiceret (se afsnit 5. 1).
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA (see section 5.1).
Behandling med Enbrel bør iværksættes og overvåges af specialister med erfaring i diagnosticering og behandling af reumatoid artrit, psoriasis artrit, ankyloserende spondylitis, 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, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis or paediatric plaque psoriasis.
Alternativt kan 50 mg Enbrel indgives en gang om ugen., hvilket er vist at være sikkert og effektivt (se afsnit 5. 1).
Alternatively, 50 mg Enbrel administered once weekly has been shown to be safe and effective (see section 5.1).
Den anbefalede dosis er 25 mg Enbrel indgivet to gange om ugen eller 50 mg indgivet en gang om ugen.
The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg Enbrel administered once weekly.
Ovenstående anbefalinger vedrørende behandlingsvarighed bør følges, hvis gentagen behandling med Enbrel er indiceret.
84 If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
Børn og unge Pædiatrisk plaque psoriasis (fra 8 år og ældre):
Paediatric plaque psoriasis (age 8 years and above)
76 Overfølsomhed over for det aktive stof eller nogle af hjælpestofferne.
Hypersensitivity to the active substance or to any of the excipients.
Hepatitis B- virus reaktivering Der er indberetninger om reaktivering af hepatitis B- virus (HBV) hos patienter, som er kroniske bærere af denne virus, og som er i behandling med TNF- antagonister, herunder Enbrel.
Reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus who are receiving TNF-antagonists including Enbrel has been reported.
77 Forværring af hepatitis C Der er indberetninger om forværring af hepatitis C hos patienter i behandling med Enbrel.
There have been reports of worsening of hepatitis C in patients receiving Enbrel.
Denne brug frarådes (se afsnit 4. 5).
86 Allergic reactions
I de kontrollerede dele af de kliniske undersøgelser med TNF- antagonister blev der observeret flere tilfælde af lymfom blandt patienter, der fik en TNF- antagonist, sammenlignet med kontrolpatienterne.
In the controlled portions of clinical trials of TNF-antagonists, more cases of lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
Der er ingen data til rådighed om sekundær transmission af infektion via levende vacciner hos patienter, som får Enbrel I en dobbeltblind, placebo - kontrolleret klinisk undersøgelse med voksne patienter med psoriasis artrit, modtog 184 af patienterne også en multivalent pneumokok polysakkarid vaccine i uge 4.
In a double blind, placebo controlled, randomised clinical study in adult patients with psoriatic arthritis 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4.
78 Dannelse af autoantistof Behandling med Enbrel kan resultere i dannelse af autoimmunantistoffer (se afsnit 4. 8).
Treatment with Enbrel may result in the formation of autoimmune antibodies (see section 4.8).
4. 5 Interaktion med andre lægemidler og andre former for interaktion
88 4.5 Interaction with other medicinal products and other forms of interaction
79 Samtidig behandling med Enbrel og anakinra For voksne patienter i behandling med Enbrel og anakinra blev der observeret en større hyppighed af alvorlige infektioner sammenlignet med patienter behandlet med enten Enbrel eller anakinra alene (historiske data).
Adult patients treated with Enbrel and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either Enbrel or anakinra alone (historical data).
Samtidig behandling hvor interaktioner ikke er observeret
Non-interactions
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
89 4.7 Effects on ability to drive and use machines
80 Enbrel er blevet undersøgt hos 2. 680 patienter med reumatoid artrit i såvel åbne som dobbelt- blindede forsøg.
Enbrel has been studied in 2,680 patients with rheumatoid arthritis in double-blind and open-label trials.
Blandt patienter med reumatoid artrit behandlet i placebokontrollerede forsøg, forekom alvorlige bivirkninger med en hyppighed på 4% hos 349 patienter behandlet med Enbrel sammenlignet med en hyppighed på 5% hos 152 placebobehandlede patienter.
Among patients with rheumatoid arthritis treated in placebo-controlled trials, serious adverse events occurred at a frequency of 4% in 349 patients treated with Enbrel compared with 5% of 152 placebo-treated patients.
I det andet aktivt kontrollerede forsøg var andelen af alvorlige bivirkninger efter 2 års behandling den samme i de tre behandlingsgrupper (Enbrel 16, methotrexat 15% og Enbrel i kombination med methotrexat 17%).
In the second active-controlled trial the rate of serious adverse events after 2 years of treatment was similar among the three treatment groups (Enbrell 16%, methotrexate 15% and Enbrel in combination with methotrexate 17%).
81 Sjælden:
Rare:
Sygdomme i hud og subkutane væv
Skin and subcutaneous tissue disorders:
Yderligere information
91 Additional information
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,
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.
Der blev rapporteret om ialt 2 maligniteter i kliniske undersøgelser af ca.
A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 Enbrel-treated psoriatic arthritis patients.
2 års varighed omfattende 240 patienter med psoriasis artrit 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 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. 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 reumatois artrit, psoriasis artrit, ankyloserende spondylitis og psoriasis.
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.
83 Alvorlige infektioner
92 Serious infections
84 I postmarketingerfaring har der været rapporter om patienter, herunder rheumatoid 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.
93 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.
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 / mm 3).
L04AB01)
L04AB01
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.
94 arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
55 -
Etanercept is a competitive inhibitor of TNF-binding to its cell surface receptors and thereby inhibits the biological activity of TNF.
85 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).
TNF og lymfotoksin eksisterer hovedsageligt som homotrimere, og deres biologiske aktivitet er afhængig af tværbinding af celleoverflade TNF- receptorer.
TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs.
Dette afsnit indeholder data fra fire randomiserede, kontrollerede undersøgelser af voksne med reumatoid artrit, en undersøgelse af voksne med psoriasis artrit, en undersøgelse af voksne med ankyloserende spondylitis, en undersøgelse af pædiatriske patienter med plaque psoriasis og fire undersøgelser af voksne med plaque psoriasis.
This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in paediatric patients with plaque psoriasis, and four studies in adults with plaque psoriasis.
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
Erfaring med længerevarende behandling findes ikke.
Continued durable responses have been seen for up to 48 months in open-label extension treatment trials when patients received Enbrel without interruption; longer-term experience is not available.
86 Effekten af Enbrel blev sammenlignet med mehotrexat i et randomiseret, aktivt kontrolleret forsøg med blindet radiografisk evaluering som primært mål hos 632 vosne patienter med aktiv reumatoid artrit (< 3 års varighed), som ikke tidligere var blevet behandlet med methotrexat.
The efficacy of Enbrel was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (< 3 years duration) who had never received treatment with methotrexate.
*
In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with Enbrel alone (25 mg twice weekly), methotrexate alone (7.5 to
I en anden aktivt- kontrolleret, dobbeltblind, randomiseret undersøgelse blev klinisk effekt, sikkerhed og radiografisk progession hos patienter med reumatoid artrit behandlet med Enbrel alene (25 mg to gange om ugen), methotrexat alene (7, 5 til 20 mg om ugen, median dosis 20 mg) og en kombination af Enbrel og methotrexat påbegyndt samtidig, sammenlignet hos 682 voksne patienter med aktiv reumatoid artrit af 6 måneder til 20 års varighed (median 5 år), som havde en mindre end tilfredsstillende respons på mindst et sygdomsmodificerende antireumatisk lægemiddel (DMARD) bortset fra methotrexat.
96 20 mg weekly, median dose 20 mg), and of the combination of Enbrel and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.
Gruppen af patienter i behandling med Enbrel i kombination med methotrexat havde signifikant højere ACR 20, ACR 50, ACR 70 respons og forbedring af DAS score ved både 24 og 52 uger end patienterne i hver af enkeltterapi grupperne (resultater vises neden for).
Patients in the Enbrel 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).
87 RESULTER FOR KLINISK EFFEKT EFTER 12 MÅNEDER:
CLINICAL EFFICACY RESULTS AT 12 MONTHS:
88 RADIOGRAFISK PROGRESSION:
97 RADIOGRAPHIC PROGRESSION:
- 0. 30 †
-0.30†
I en analyse, hvor alle patienter, som uanset grund udgik af undersøgelsen, blev anset for at have progression, varprocentdelen af patienter uden progession (TSS ændring ≤ 0. 5) efter 24 måneder højere i gruppen, som fik Enbrel i kombination med methotrexat sammenlignet med grupperne som fik Enbrel alene og methotrexat alene (henholdsvis 62%, 50%, og 36%; p < 0. 05).
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the Enbrel in combination with methotrexate group compared with the Enbrel alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p < 0.05).
En enkelt 50 mg/ ml injektion med etanercept vistes at være bioekvivalent til to samtidige injektioner med 25 mg/ ml.
A single 50 mg/ ml injection of Enbrel was found to be bioequivalent to two simultaneous injections of 25 mg/ ml.
Patienterne var mellem 18 og 70 år gamle og havde aktiv psoriasis artrit (≥ 3 svulne led og ≥ 3 ømme led) i mindst en af følgende former:
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) i distale interfalangeale led, (2) polyartikulær artrit (ingen reumatoide knuder og tilstedeværelse af psoriasis), (3) arthritis mutilans, (4) asymetrisk psoriasis artrit eller (5) spondylitis- lignende ankylose.
(1) distal 98 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.
Patienterne var tidligere blevet behandlet med NSAID (86%),
Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%).
Patienter, som var i gang med methotrexat- behandling (stabile ≥ 2 måneder) kunne fortsætte på en fast dosis på ≤ 25 mg/ uge methotrexat.
Patients currently on methotrexate therapy (stable for  2 months) could continue at a stable dose of  25 mg/ week methotrexate.
RESPONS HOS PATIENTER MED PSORIASIS ARTRIT I PLACEBOKONTROLLEREDE FORSØG% af patienter
RESPONSES OF PATIENTS WITH PSORIATIC ARTHRITIS IN PLACEBO-CONTROLLED TRIAL Percent of Patients
25 mg Enbrel subkutant to gange om ugen b: p < 0. 001, Enbrel vs. placebo c: p < 0. 01, Enbrel vs. placebo
25 mg Enbrel SC twice weekly b: p  0.001, Enbrel vs. placebo c: p  0.01, Enbrel vs. placebo
Enbrel var signifikant bedre end placebo på alle mål for sygdomsaktivitet (p < 0, 001), og responsen var den samme med og uden samtidig methotrexat- behandling.
Enbrel was significantly better than placebo in all measures of disease activity (p  0.001), and responses were similar with and without concomitant methotrexate therapy.
Scoren på invaliditetsindekset blev signifikant forbedret på alle tidspunkter hos patienter med psoriasis artrit i behandling med Enbrel i sammenligning med placebo (p < 0, 001).
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with Enbrel, relative to placebo (p  0.001).
I en analyse, hvor alle patienter, som uanset grund udgik af undersøgelsen, blev anset for at have progression, var procentdelen af patienter uden progession (TSS ændring ≤ 0. 5) efter 12 måneder højere i gruppen, som fik Enbrel, sammenlignet med placebogruppen (henholdsvis 73% og 47%, p ≤ 0, 001).
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12
90 MIDDEL (SE) ÆNDRING FRA BASELINE I TOTAL SHARP SCORE PÅ ÅRSBASIS
MEAN (SE) ANNUALIZED CHANGE FROM BASELINE IN TOTAL SHARP SCORE
Behandling med Enbrel resulterede i forbedret fysisk funktion i den dobbeltblinde undersøgelsesperiode, og denne bedring blev fastholdt i den forlængede undersøgelse 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.
91 RESPONS FRA PATIENTER MED ANKYLOSERENDE SPONDYLITIS I EN PLACEBOKONTROLLERET UNDERSØGELSE Procent patienter
100 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
I en fjerde undersøgelse blev sikkerhed og effekt af 50 mg Enbrel (to gange 25 mg subkutane injektioner) indgivet en gang om ugen versus 25 mg Enbrel indgivet to gange om ugen vurderet i en dobbeltblind, placebokontrolleret undersøgelse med 356 patienter med aktiv ankyloserende spondylitis.
In a fourth study, the safety and efficacy of 50 mg Enbrel (two 25 mg SC injections) administered once weekly vs 25 mg Enbrel administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
Sikkerheden og effekten af Enbrel er i stedet for blevet evaluereti tre randomiserede, dobbeltblinde, placebo- kontrollerede undersøgelser.
Instead, the safety and efficacy of Enbrel were assessed in four randomised, double-blind, placebo-controlled studies.
Det primære slutmål for effekt var i alle tre 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.
Patienterne var ≥ 18 år.
101 Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving  10% of the body surface area that were  18 years old.
Efter 12 ugers behandling begyndte patienterne i placebogruppen behandling med blindet Enbrel (25 mg to
After 12 weeks of treatment, patients in the placebo group began treatment with blinded Enbrel (25 mg twice a week); patients in the active treatment groups continued to week 24 on the dose to which they were originally randomised.
PASI 50
wk
14 58 * 70 74 * 77 9 64 * 77 * 9
12 162 162 164 164 wk 12 wk wk wk wk 12 24a 12 24a
69 *
wk 12 wk 12 wk
83
12
PASI 75
wk 12
34 *
wk 24a
44
PASI 50 PASI 75 DSGA b, clear or almost
49 *
14 58* 70 74* 77 9 4 34* 44 49* 59 3
59 3 34 * 49 *
64* 77* 34* 49*
2
9 2
I studie 2 var der også en periode uden behandling, hvor patienter, som efter 24 uger havde opnået en forbedring på mindst 50% på PASI, fik stoppet behandlingen.
102 Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
93 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 75 response 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.
Antistoffer mod Enbrel Antistoffer mod etanercept er blevet konstateret i sera hos nogle patienter i behandling med etanercept.
Antibodies to etanercept have been detected in the sera of some subjects treated with etanercept.
Middel serumkoncentrationsprofilerne ved steady- state, dvs Cmax (2, 4 mg/ l vs 2, 6 mg/ l), Cmin (1, 2 mg/ l vs 1, 4 mg/ l) og partiel AUC (297 mgh/ l vs 316 mgh/ l), vistes at være sammenlignelige hos patienter med reumatoid artrit behandlet med henholdsvis 50 mg etanercept en gang om ugen (n=21) og 25 mg etanercept to gange om ugen (n=16).
Cmax (2.4 mg/ l vs 2.6 mg/ l), Cmin (1.2 mg/ l vs 1.4 mg/ l) and partial AUC (297 mgh/ l vs 316 mgh/ l), were shown to be comparable in RA patients treated with 50 mg etanercept once weekly (n=21) and 25 mg etanercept twice weekly (n=16), respectively.
I en åben, enkeltdosis, dobbeltbehandling, cross- over undersøgelse med sunde frivillige, blev etanercept indgivet som en enkelt 50 mg/ ml injektion fundet at være bioekvivalent til to samtidige injektioner af 25 mg/ ml.
In an open-label, single-dose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ ml.
I en farmakokinetisk analyse af patienter med ankyloserende spondylitis var etanercept steady- state AUC henholdsvis 466 µg* t/ ml og 474 µg* t/ ml for 50 mg Enbrel en gang om ugen (N = 154) og 25 mg to gange om ugen (N = 148).
In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466  g hr/ ml and 474  g hr/ ml for 50 mg Enbrel once weekly (N= 154) and 25 mg twice weekly (N = 148), respectively.
Selvom der er eliminering af radioaktivitet i urinen efter indgivelse af radioaktivt mærket etanercept til patienter og frivillige, blev der ikke observeret forøgede etanercept- koncentrationer hos patienter med akut nyre - eller leversvigt.
104 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
95 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
6. 3 Opbevaringstid
105 6.3 Shelf life
96 6. 6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal and other handling
Enbrel 50 rekonstitueres med 1 ml vand til injektion før brug og indgives som en subkutan injektion..
Enbrel is reconstituted with 1 ml water for injections before use, and administered by subcutaneous injection.