natgillin/translations-raw huggingface dataset:
97 1.
107 1.
Enbrel 50 mg pulver og solvens til injektionsvæske, opløsning
Enbrel 50 mg powder and solvent for solution for injection.
Hos patienter med psoriasis artrit 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.
108 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.
98 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).
Enbrel findes i styrkerne 25 og 50 mg.
Enbrel is available in strengths of 25 and 50 mg.
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).
Ovenstående anbefalinger vedrørende behandlingsvarighed bør følges, hvis gentagen behandling med Enbrel er indiceret.
109 If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
99 Sepsis eller risiko for sepsis.
Sepsis or risk of sepsis.
100 Samtidig behandling med Enbrel og anakinra Samtidig administration af Enbrel og anakinra er blevet forbundet med en øget risiko for alvorlige infektioner og neutropeni sammenlignet med Enbrel alene.
Concurrent administration of Enbrel and anakinra has been associated with an increased risk of serious infections and neutropenia compared to Enbrel alone.
Allergiske reaktioner Der er hyppigt rapporteret om allergiske reaktioner associeret med indgivelse af Enbrel.
111 Allergic reactions associated with Enbrel administration have been reported commonly.
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.
101 Hæmatologiske reaktioner Sjældne tilfælde af pancytopeni og meget sjældne tilfælde af aplastisk anæmi, nogle med dødeligt udfald, er rapporteret hos patienter i behandling med Enbrel.
Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with Enbrel.
4. 5 Interaktion med andre lægemidler og andre former for interaktion
113 4.5 Interaction with other medicinal products and other forms of interaction
102 I en dobbeltblind placebo- kontrolleret undersøgelse blandt voksne patienter, der basalt blev behandlet med methotrexat, blev patienterne behandlet med Enbrel og anakinra desuden observeret at have en større hyppighed af alvorlige infektioner (7%) og neutropeni end patienterne behandlet med Enbrel (se afsnit 4. 4 og 4. 8).
In addition, in a double-blind placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with Enbrel (see sections 4.4 and 4.8).
4. 7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner
114 4.7 Effects on ability to drive and use machines
Den procentdel af patienter, som ophørte med behandlingen på grund af bivirkninger, var den samme i både Enbrel - og
This experience includes 2 placebo-controlled studies (349 Enbrel patients and 152 placebo patients) and 2 active-controlled trials, one active-controlled trial comparing Enbrel to methotrexate (415 Enbrel patients and 217 methotrexate patients) and another active-controlled trial comparing Enbrel (223 patients), methotrexate (228 patients) and Enbrel in combination with methotrexate (231 patients).
103 placebobehandlingsgruppen; i det første aktivt kontrollerede forsøg var det procentvise frafald signifikant højere blandt de patienter som modtog methotrexat (10%) end det var for de patienter som modtog Enbrel (5%).
The proportion of patients who discontinued treatment due to adverse events was the same in both the Enbrel and placebo treatment groups; in the first active-controlled trial, the dropout rate was significantly higher for methotrexate (10%) than for Enbrel (5%).
Desuden er Enbrel undersøgt hos 240 patienter med psoriasis artrit, som deltog i 2 dobbeltblinde placebokontrollerede undersøgelser og en åben, forlænget undersøgelse.
Additionally, Enbrel has been studied in240 psoriatic arthritis patients who participated in 2 double-blind placebo- controlled studies and an open-label extension study.
Femhundredeotte (508) patienter med ankyloserende spondylitis blev behandlet med Enbrel i 4 dobbeltblinde placebokontrollerede undersøgelser.
Five hundred and eight (508) ankylosing spondylitis patients were treated with Enbrel in 4 double-blind placebo-controlled studies.
Enbrel er også undersøgt i 4 dobbeltblinde placebo - kontrollerede 6 måneders undersøgelser hos 1. 180 patienter med plaque psoriasis.
Enbrel has also been studied in 1,180 patients with plaque psoriasis for up to 6 months in 4 double-blind placebo-controlled studies.
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 (Enbrel 16%, methotrexate 15% and Enbrel in combination with methotrexate 17%).
Trombocytopeni Anæmi, leukopeni, neotropeni, pancytopeni * Aplastisk anæmi *
Thrombocytopenia Anaemia, leukopenia, neutropenia, pancytopenia* Aplastic anaemia*
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)
Yderligere information
116 Additional information
Blandt patienter med reumatoid artrit, psoriasis artrit, ankyloserende spondylitis og plaque psoriasis i placebokontrollerede, aktivtkontrollerede 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.
De observerede tal og
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.
105 forekomster i disse kliniske forsøg svarede til dem, der forventedes for den behandlede gruppe.
The observed rates and incidences in these clinical trials were similar to those expected for the population studied.
Alvorlige infektioner
117 Serious infections
I det toårige aktivt kontrollerede forsøg, hvor patienterne blev behandlet med enten Enbrel alene, methotrexat alene eller Enbrel i behandling 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.
106 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.
Der har været sjældne rapporter om patienter, herunder rheumatoid faktor positive patienter, som har udviklet andre autoantistoffer i forbindelse med lupus- lignende syndrom eller udslæt, som er kompatibel med subaktiv kutan lupus eller diskoid lupus ved klinisk præsentation og biopsi.
118 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.
107 I kliniske undersøgelser omkring juvenil idiopatisk artrit var der 4 indberetninger om makrofag - aktiverings- syndrom.
There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
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
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.
119 arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
Etanercept er en kompetitiv inhibitor af TNF- binding til celleoverfladereceptorer og hæmmer dermed TNF’ s biologiske aktivitet.
In plaque psoriasis, infiltration by inflammatory cells including T-cells leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
TNF og lymfotoksin er pro- inflammatoriske cytokiner, som binder sig til to adskilte celleoverfladereceptorer:
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).
108 Voksne patienter med reumatoid artrit Enbrels effekt blev vurderet i en randomiseret, dobbelt- blind, placebokontrolleret undersøgelse.
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study.
Fortsat, varig respons er set i op til 48 måneder i åbne, forlængede undersøgelser hos patienter som fik Enbrel unden afbrydelse. 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.
109 RADIOGRAFISK PROGRESSION:
RADIOGRAPHIC PROGRESSION:
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.
121 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 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.
110 RESULTER FOR KLINISK EFFEKT EFTER 12 MÅNEDER:
CLINICAL EFFICACY RESULTS AT 12 MONTHS:
111 RADIOGRAFISK PROGRESSION:
122 RADIOGRAPHIC PROGRESSION:
(1) i distale interfalangeale led, (2) polyartikulær artrit (ingen reumatoide knuder og tilstedeværelse af psoriasis), (3) arthritis mutilans, (4)
(1) distal 123 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.
113 MIDDEL (SE) ÆNDRING FRA BASELINE I TOTAL SHARP SCORE PÅ ÅRSBASIS
MEAN (SE) ANNUALIZED CHANGE FROM BASELINE IN TOTAL SHARP SCORE
= 104)
(n = 104)
114 RESPONS FRA PATIENTER MED ANKYLOSERENDE SPONDYLITIS I EN PLACEBOKONTROLLERET UNDERSØGELSE Procent patienter
125 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 dobbelt- blind, placebo- kontrolleret 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.
Patienterne var ≥ 18 år.
126 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
During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three Enbrel doses.
25 mg
50 mg
50 mg 50 mg
Placebo
50 mg
BIW
Placebo 25 mg 2 x uge 50 mg 2 x uge Placebo n = 166 n =162 n =162 n = 164 n = 164 n = 193
BIW Placebo BIW BIW Placebo QW
2 x uge 2 x uge Placebo 1 x uge n = 196 n = 196 n = 46 n = 96
166 n = n = n = n = n = 193 n = 196 n = 196 n = 46
uge 12 uge 12
wk
uge 24a uge 12 uge 24a uge 12 uge 12 uge
12 162 162 164 164 wk 12 wk wk wk wk 12 24a 12 24a
12 uge 12 uge 12
wk 12 wk 12 wk
9 64 *
wk 12
77 * 9
wk 24a
69 *
PASI 50 PASI 75 DSGA b, clear or almost
83
14 58* 70 74* 77 9 4 34* 44 49* 59 3
44
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.
127 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.
116 psoriasis- relaterede alvorlige bivirkninger.
No rebound flare of disease and no psoriasis-related serious adverse events were observed.
Antistoffer mod Enbrel
128 Antibodies to Enbrel
117 Andelen af patienter, som udvikler antistoffer mod etanercept i langtidsundersøgelser (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.
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.
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.
129 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.
Disse middelkoncentrationer hos patienter med pædiatrisk plaque psoriasis var de samme som de koncentrationer, der blev observeret hos
These mean concentrations in patients with paediatric plaque psoriasis were similar to the concentrations observed in patients with juvenile idiopathic arthritis (treated with 0.4 mg/ kg etanercept twice weekly, up to maximum dose of 50 mg per week).
6. 2 Uforligeligheder
130 6.2 Incompatibilities
6. 4 Særlige opbevaringsforhold
6.6 Special precautions for disposal and other handling
Æskerne indeholder 2, 4 eller 12 hætteglas Enbrel med 2, 4 eller 12 forfyldte sprøjter med solvens, 2, 4 eller 12 kanyler, 2, 4 eller 12 adaptere og 4, 8 eller 24 alkoholservietter. Ikke nødvendigvis alle pakningsstørrelser markedsføres.
Not all pack sizes may be marketed.
119 6. 6 Regler for destruktion og anden håndtering
6.6 Special precautions for disposal
120 1.
132 1.
Enbrel 25 mg/ ml pulver og solvens til injektionsvæske, opløsning, til pædiatrisk brug.
Enbrel 25 mg/ ml powder and solvent for solution for injection for paediatric use.
Efter rekonstitution indeholder opløsningen 25 mg/ ml etanercept.
When reconstituted, the solution contains 25 mg/ ml of etanercept.
4. 4).
The solution contains benzyl alcohol 9 mg/ ml as a preservative (see section 4.4).
Hvert hætteglas Enbrel 25 mg/ ml bør bruges til maksimalt 2 doser indgivet til samme patient.
133 Each vial of Enbrel 25 mg/ ml should be used for a maximum of 2 doses administered to the same patient.
Detaljeret vejledning om forberedelse, indgivelse og genbrug af rekonstitueret Enbrel findes i indlægssedlen, afsnit 7, ” Vejledning til forberedelse af og indgivelse af Enbrel ”.
Comprehensive instructions for the preparation, administration and re-use of the reconstituted Enbrel vial are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
121 0, 4 mg/ kg (op til et maximum på 25 mg per dosis) efter rekonstitution af 25 mg Enbrel i 1 ml solvens, indgivet to gange ugentligt som subkutan injektion med et interval på 3- 4 dage mellem doserne.
0.4 mg/ kg (up to a maximum of 25 mg per dose) after reconstitution of 25 mg Enbrel in 1 ml of solvent, given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses.
Enbrel må ikke gives til premature spædbørn eller nyfødte, da solvensen indeholder benzylalkohol.
Enbrel must not be given to premature babies or neonates as the solvent contains benzyl alcohol.
Patienter, som udvikler en ny infektion, mens de gennemgår behandling med Enbrel, bør overvåges nøje.
134 Patients who develop a new infection while undergoing treatment with Enbrel should be monitored closely.
Hvis diagnosen inaktiv (latent) tuberkulose stilles, skal behandling af latent tuberkulose påbegyndes med anti -
If inactive (‘ latent’) tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Enbrel, and in accordance with local recommendations.
123 Forekomsten var dog sjælden, og opfølgningstiden for placebo patienter var kortere end for patienter, der fik TNF- antagonistbehandling.
However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.
I denne undersøgelse var de fleste psoriasis artrit patienter behandlet med Enbrel i stand til at rejse en effektivt B- celle immunrespons mod pneumokok polysakkarid vaccine, men aggregattitrene var moderat lavere, og få patienter havde dobbelt stigning i titrene i sammenligning med patienter, som ikke fik Enbrel.
In this study most psoriatic arthritis patients receiving Enbrel were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine,
Alle patienter og forældre / plejere skal informeres om, at hvis patienten udvikler tegn eller symptomer, som kan pege på bloddyskrasi eller infektioner (f. eks. vedvarende feber, øm hals, blå mærker, blødning, bleghed), mens de er i behandling med Enbrel, skal de omgående søge læge.
All patients and parents/ caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e. g. persistent fever, sore throat, bruising, bleeding, paleness) whilst on Enbrel, they should seek immediate medical advice.
Kombinationsbehandling I en kontrolleret klinisk afprøvning af to års varighed med voksne patienter med reumatoid artrit resulterede kombinationen Enbrel og methotrexat ikke i uventede sikkerhedsfund, og sikkerhedsprofilen for Enbrel givet i kombination med methotrexat var den samme som de profiler, der er rapporteret fra undersøgelser af Enbrel og methotrexat alene.
In a controlled clinical trial of two years duration in adult rheumatoid arthritis patients, the combination of Enbrel and methotrexate did not result in unexpected safety findings, and the safety profile of Enbrel when given in combination with methotrexate was similar to the profiles reported in studies of Enbrel and methotrexate alone.
124 Der har været postmarketingrapporter om forværring af CHF, med og uden identificerbare fremskyndende faktorer hos patienter der tager Enbrel.
There have been postmarketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking Enbrel.
Enbrel indeholder benzylalkohol som indholdsstof, hvilket kan forårsage toksiske reaktioner og anafylaktoide reaktioner hos spædbørn og børn op til 3 års alderen, og må ikke gives til premature spædbørn eller nyfødte.
Enbrel contains benzyl alcohol as an excipient, which may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old and must not be given to premature babies or neonates.
4. 6 Graviditet og amning
138 4.6 Pregnancy and lactation
Anvendelse af Enbrel til gravide
Thus, the use of Enbrel in pregnant women is not recommended, and women of child-bearing potential should be advised not to get pregnant during Enbrel therapy.
125 kvinder kan derfor ikke anbefales, og kvinder i den fødedygtige alder bør rådes til ikke at blive gravide under behandling med Enbrel.
Use during lactation