FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with LIFMIOR and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with LIFMIOR (see sections 4.4 and 4.8).
Danish: I et dobbeltblindt placebo-kontrolleret studie blandt voksne patienter, der basalt blev behandlet med methotrexat, blev patienterne behandlet med LIFMIOR og anakinra desuden observeret at have en større hyppighed af alvorlige infektioner (7 %) og neutropeni end patienterne behandlet med LIFMIOR (se pkt.
English: Diagram 15
Danish: Billede 15
English: Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.
Danish: Behandling af psoriasisartrit hos unge i alderen fra 12 år, som har vist utilstrækkeligt respons på eller intolerans over for methotrexat.
English: Reports of various malignancies (including breast and lung carcinoma and lymphoma) have been received in the postmarketing period (see section 4.8).
Danish: bryst- og lungecarcinom og lymfom), er blevet modtaget i postmarketingperioden (se pkt.
English: Preparing the LIFMIOR dose for injection d. Adding solvent e.
Danish: Forberedelse af LIFMIOR dosis til injektion d.
English: Each vial of LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use contains 10 mg of etanercept.
Danish: Hvert hætteglas LIFMIOR 10 mg pulver og solvens til injektionsvæske, opløsning, til pædiatrisk brug indeholder 10 mg etanercept.
English: 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 ciclosporin, methotrexate or psoralen and ultraviolet-A light (PUVA) (see section 5.1).
Danish: Behandling af voksne med moderat til svær plaque psoriasis, som har vist utilstrækkeligt respons på, eller viste sig at være intolerante overfor, anden systemisk behandling inklusiv ciclosporin, methotrexat eller psoralen og ultraviolet-A lys (PUVA), eller hvor den systemiske behandling inklusiv ciclosporin, methotrexat eller PUVA er kontraindiceret (se pkt.
English: After removal of the needle cap, you will see a purple needle safety shield extending slightly from the end of the pen.
Danish: Efter at nålehætten er taget af, kan man se en lilla sikkerhedshætte, der beskytter nålen.
English: Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)*
Danish: Reaktioner på injektionsstedet (herunder blødning, blå mærker, erytem, kløe, smerte, hævelse)*
English: 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 adults with non-radiographic axial spondyloarthritis, four studies in adults with plaque psoriasis, three studies in juvenile idiopathic arthritis and one study in paediatric patients with plaque psoriasis.
Danish: Dette afsnit indeholder data fra fire randomiserede, kontrollerede studier hos voksne med reumatoid artrit, et studie hos voksne med psoriasisartrit, et studie hos voksne med ankyloserende spondylitis, et studie hos voksne med nonradiografisk spondylartrit, fire studier hos voksne med plaque psoriasis, tre studier hos patienter med juvenil idiopatisk artrit og et studie hos pædiatriske patienter med plaque psoriasis.
English: Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions
Danish: hypersensitivitets vaskulitis), erythema multiforme, lichenoide reaktioner
English: The needle cover of the pre-filled syringe contains latex (dry natural rubber) that may cause hypersensitivity reactions when handled by, or when LIFMIOR is administered to, persons with known or possible latex sensitivity.
Danish: Nålehætten på den fyldte pen indeholder latex (tørt naturgummi), som kan forårsage overfølsomhedsreaktioner, hvis det håndteres af, eller hvis LIFMIOR indgives til, personer med kendt eller mulig overfølsomhed over for latex.
English: Diagram 16
Danish: Billede 16
English: LIFMIOR is supplied as a solution for injection in a pre-filled pen (MYCLIC) (solution for injection).
Danish: LIFMIOR leveres som en injektionsvæske til injektion i en fyldt pen (MYCLIC).
English: The mean serum steady-state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48.
Danish: De gennemsnitlige steady-state trough-koncentrationer varierede fra 1,6 til 2,1 mcg/ml ved uge 12, 24 og 48.
English: 4 MYCLIC pre-filled pens 4 alcohol swabs
Danish: 4 MYCLIC fyldte penne 4 alkoholservietter
English: In part 2, 6 of 25 (24%) patients remaining on LIFMIOR experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p=0.007).
Danish: I første del af studiet viste 51 af 69 (74 %) af patienterne klinisk respons og deltog i anden del. I anden del fik 6 af 25 (24 %) patienter, som fortsatte med LIFMIOR, sygdomsopblussen sammenlignet med 20 af 26 (77 %) patienter, som fik placebo (p=0,007).
English: Treatment with LIFMIOR should not be initiated in patients with active infections including chronic or localised infections.
Danish: Behandling med LIFMIOR bør ikke påbegyndes hos patienter med aktive infektioner, inkl.
English: Diagram 12
Danish: Billede 12
English: For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Danish: Patienter, der testes positive for HBV-infektion, bør konsultere en læge med ekspertise i behandling af hepatitis B. Der bør udvises forsigtighed, hvis LIFMIOR gives til patienter, der tidligere har været inficeret med HBV.
English: For psoriasis in patients from the age of 6 years, the usual dose is 0.8 mg of LIFMIOR per kg bodyweight (up to a maximum of 50 mg), and should be given once weekly.
Danish: Til psoriasis hos patienter fra 6 års-alderen er den sædvanlige dosis 0,8 mg LIFMIOR per kg kropsvægt (op til højst 50 mg per dosis) en gang om ugen.
English: Leave the white needle cap in place and wait approximately 15-30 minutes to allow the LIFMIOR solution in the pen to reach room temperature.
Danish: Lad den hvide nålehætte blive siddende på pennen og vent ca. 15-30 minutter til LIFMIORinjektionsvæsken i pennen har opnået stuetemperaturtur.
English: Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
Danish: Inklusionskriterierne var de samme som i studie 1 med den tilføjelse, at patienterne havde et minimum psoriasis areal og sværheds indeks (PASI) på 10 ved screeningen.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2)
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (jf. bilag I: Produktresumé; pkt.
English: Among patients with psoriatic arthritis who received LIFMIOR, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Danish: Blandt patienter med psoriasisartrit, som fik LIFMIOR, var det kliniske respons tydeligt på tidspunktet for første besøg (4 uger) og blev opretholdt gennem 6 måneders behandling.
English: • Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching.
Danish: • Tegn på betændelse i blodkarrene, herunder smerter, feber, rødme eller varme i huden eller kløe.
English: • Wipe the site where LIFMIOR is to be injected with a new alcohol swab, using a circular motion.
Danish: • Tør området, hvor LIFMIOR skal injiceres, af med en ny alkoholserviet med cirkulære bevægelser.
English: Diagram 7
Danish: Billede 7
English: Frequency Not Known (Cannot be Estimated from Available Data) syndrome)†
Danish: • Ikke kendt (hyppigheden kan ikke fastsættes ud fra forhåndenværende data): En form for hudkræft (Merkelcellekarcinom).
English: If this is the case, start again with another vial.
Danish: Begynd igen med et andet glas, hvis det ikke er tilfældet.
English: • Select a clean well-lit, flat working surface.
Danish: • Vælg en ren, godt belyst, plan arbejdsflade.
English: Among patients with ankylosing spondylitis who received LIFMIOR, the clinical responses were apparent at the time of the first visit (2 weeks) and were maintained through 6 months of therapy.
Danish: Hos patienter med ankyloserende spondylitis, som fik LIFMIOR, var det kliniske respons synligt på tidspunktet for første besøg (2 uger) og blev opretholdt gennem 6 måneders behandling.
English: Abbreviation: sPGA-static Physician Global Assessment.
Danish: sPGA ”klar” eller ”minimal”, n ( %) Forkortelse: sPGA: static Physician Global Assessment a.
English: Diagram 11
Danish: Billede 11
English: Malignant melanoma (see section 4.4), lymphoma, leukaemia
Danish: 4.4), lymfom, leukæmi
English: 30 months.
Danish: 30 måneder
English: 2 MYCLIC pre-filled pens 2 alcohol swabs
Danish: 2 MYCLIC fyldte penne 2 alkoholservietter
English: Pick up the pre-filled syringe from the flat work surface.
Danish: • Tag den fyldte injektionssprøjte fra den plane arbejdsflade.
English: Pairwise comparison p-values: * = p < 0.05 for comparisons of LIFMIOR vs. methotrexate, † = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. methotrexate and φ = p < 0.05 for comparisons of LIFMIOR + methotrexate vs. LIFMIOR.
Danish: Parvis sammenligning af p-værdier: * = p < 0,05 for sammenligning af LIFMIOR vs. methotrexat, † = p < 0,05 for sammenligning af LIFMIOR + methotrexat vs. methotrexat og  = p < 0,05 for sammenligning af LIFMIOR + methotrexat vs. LIFMIOR
English: The pre-filled syringe is available in dose strengths of 25 mg and 50 mg.
Danish: Den fyldte injektionssprøjte findes i doseringsstyrkerne 25 mg og 50 mg.
English: Diagram 19
Danish: Billede 19
English: There may be a little bleeding at the injection site.
Danish: Der kan forekomme let blødning.
English: The mean serum steady state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48.
Danish: De gennemsnitlige steady-state trough-koncentrationer i serum varierede fra 1,6 til 2,1 mcg/ml ved uge 12, 24 og 48.
English: After 12 weeks of treatment,
Danish: Dette blev opretholdt gennem 24 ugers behandling.
English: Serious and fatal infections have been reported during use of LIFMIOR; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi.
Danish: Rapporterede patogener omfatter bakterier, mykobakterier (herunder tuberkulose), vira og svamp.
English: Adult patients with plaque psoriasis
Danish: Voksne patienter med plaque psoriasis
English: Infection (including upper respiratory tract infection, bronchitis, cystitis, skin infection)*
Danish: Infektion (inklusive øvre luftvejsinfek tion, bronkitis, blærebetænd else, hudinfektion)*
English: Each pack contains 2, 4 or 12 pens and 2, 4 or 12 alcohol swabs.
Danish: Hver pakke indeholder 2, 4 eller 12 penne og 2, 4 eller 12 alkoholservietter.
English: The efficacy of LIFMIOR was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by a sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
Danish: Effekten af LIFMIOR blev vurderet i et randomiseret, dobbeltblindt, placebo-kontrolleret studie med 211 pædiatriske patienter i alderen 4 til 17 år med moderat til svær plaque psoriasis (defineret ved en sPGA score  3, omfattende  10 % af BSA og PASI 12).
English: For polyarthritis or extended oligoarthritis in patients from the age of 2 years, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12 years, the usual dose is 0.4 mg of LIFMIOR per kg bodyweight (up to a maximum of 25 mg) given twice weekly, or 0.8 mg of LIFMIOR per kg of bodyweight (up to a maximum of 50 mg) given once weekly.
Danish: Til polyartrit eller udvidet oligoartrit hos patienter fra 2-års-alderen, og til enthesitis-relateret artrit eller psoriasisgigt hos patienter fra 12 års alderen er den sædvanlige dosis 0,4 mg LIFMIOR per kg kropsvægt (op til højst 25 mg per dosis) to gange om ugen, eller 0,8 mg LIFMIOR per kg kropsvægt (op til højst 50 mg per dosis) en gang om ugen.
English: After 12 weeks of treatment, patients in the placebo group began treatment with blinded LIFMIOR (25 mg twice a week); patients in the active treatment groups continued to week 24 on the dose to which they were originally randomised.
Danish: Efter 12 ugers behandling begyndte patienterne i placebogruppen behandling med blindet LIFMIOR (25 mg to gange om ugen).
English: Diagram 10
Danish: Billede 10
English: Immunosuppression
Danish: Immunsystemet
English: After taking a pre-filled pen from the refrigerator, wait approximately 15-30 minutes to allow the LIFMIOR solution in the pen to reach room temperature.
Danish: Når pennen er taget ud af køleskabet, skal du vente ca. 15-30 minutter på, at LIFMIORinjektionsvæsken i pennen opnår stuetemperatur.
English: NEVER re-cap a needle.
Danish: Sæt ALDRIG hætten tilbage på kanylen.
English: Use in children and adolescents
Danish: Dosering til børn og teenagere
English: The needle cover should not be removed while allowing the prefilled syringe to reach room temperature.
Danish: Nålehætten skal ikke fjernes imens den fyldte injektionssprøjte opnår stuetemperatur.
English: CARTON TEXT (For paediatric use) - EU/1/16/1165/001
Danish: YDERKARTON - (Til pædiatrisk brug) - EU/1/16/1165/001
English: After taking a syringe from the refrigerator, wait approximately 15-30 minutes to allow the LIFMIOR solution in the syringe to reach room temperature.
Danish: Når sprøjten er taget ud af køleskabet, skal du vente ca. 15-30 minutter på at LIFMIORinjektionsvæsken i sprøjten opnår stuetemperatur.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof eller overfor et eller flere af hjælpestofferne anført i pkt.
English: The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever.
Danish: kløe, rødme og blødning på indstiksstedet), infektioner (som infektioner i de øvre luftveje, bronkitis, blæreinfektioner og hudinfektioner), allergiske reaktioner, udvikling af autoantistoffer, kløe og feber.
English: If you have any questions about storage, contact your doctor, nurse, or pharmacist for further instructions.
Danish: Kontakt din læge, sygeplejerske eller apoteket for yderligere instruktioner hvis du har nogen spørgsmål om opbevaring.
English: Clear glass vial (4 ml, type I glass) with rubber stoppers, aluminium seals, and flip-off plastic caps.
Danish: Klart hætteglas (4 ml, type I glas) med gummipropper, aluminiumssegl, og plastiklåg til at skubbe af.
English: Name and address of the manufacturers responsible for batch release Wyeth Pharmaceuticals
Danish: Navn og adresse på fremstillerne ansvarlige for batchfrigivelse
English: Study 3 evaluated 583 patients and had the same inclusion criteria as study 2.
Danish: Studie 3 evalueredes 583 patienter.
English: Cartons contain 4 vials of LIFMIOR, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs.
Danish: Æskerne indeholder 4 hætteglas LIFMIOR, 4 fyldte injektionssprøjter med vand til injektionsvæsker, 4 kanyler, 4 hætteglasadaptorer og 8 alkoholservietter.
English: A placebo-controlled trial, in which 89 adult patients were treated with LIFMIOR in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown LIFMIOR to be an effective treatment for Wegener's granulomatosis.
Danish: cyclofosfamid eller methotrexate, og glucokortikoider) i gennemsnitligt 25 måneder, viste ikke at LIFMIOR var effektivt til behandling af Wegeners granulomatose.
English: Method of administration
Danish: ANVENDELSESMETODE
English: LIFMIOR 10 mg powder and solvent for solution for injection for paediatric use is supplied as a white powder with solvent for solution for injection (powder for injection).
Danish: LIFMIOR pulver og solvens til injektionsvæske, opløsning, til pædiatrisk brug leveres som et hvidt pulver og solvens til opløsning til injektion (pulver til injektion).
English: Do not inject into areas where the skin is tender, bruised, red, or hard.
Danish: Du må ikke injicere på et område, hvor huden er øm, stødt eller hård.
English: The efficacy of LIFMIOR was assessed in a randomised, double-blind, placebo-controlled study.
Danish: LIFMIORs effekt blev vurderet i en randomiseret, dobbelt-blind, placebokontrolleret studie.
English: The usual dose is 25 mg twice a week or 50 mg once a week.
Danish: Den almindelige dosis er 25 mg to gange om ugen eller 50 mg en gang om ugen.
English: No dose adjustment is required.
Danish: Ældre Der kræves ingen dosisjustering.
English: Check with the doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
English: 8 alcohol swabs
Danish: 8 alkoholservietter
English: In the double-blind periods of controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of adverse events of elevated liver enzymes was 4.18% (frequency common).
Danish: I de dobbeltblinde perioder i kontrollerede studier, der tillod samtidig behandling med etanercept og methotrexat, var hyppigheden af bivirkningen 'forhøjede leverenzymer' 4,18 % (hyppighed 'almindelig').
English: Immune system disorders
Danish: Svækkelse af immunforsvaret
English: In a controlled clinical trial of two years duration in adult rheumatoid arthritis patients, the combination of LIFMIOR and methotrexate did not result in unexpected safety findings, and the safety profile of LIFMIOR when given in combination with methotrexate was similar to the profiles reported in studies of LIFMIOR and methotrexate alone.
Danish: I en kontrolleret klinisk afprøvning af to års varighed med voksne patienter med reumatoid artrit resulterede kombinationen LIFMIOR og methotrexat ikke i uventede sikkerhedsfund, og sikkerhedsprofilen for LIFMIOR givet i kombination med methotrexat var den samme som de profiler,
English: • Holding the glass barrel of the syringe (not the white collar) in one hand, and the vial adaptor (not the vial) in the other, connect the syringe to the vial adaptor by inserting the tip into the opening and turn clockwise until completely secured (see Diagram 7).
Danish: • Hold på selve glasset på sprøjten (ikke den hvide krave) med den ene hånd og adapteren (ikke hætteglasset) med den anden.
English: Diagram 14
Danish: Billede 14
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
Danish: I kliniske studier omkring juvenil idiopatisk artrit var der 4 indberetninger om makrofag-aktiveringssyndrom.
English: Diagram 13
Danish: Billede 13
English: • Not known (frequency cannot be estimated from the available data): Merkel cell carcinoma (a type of skin cancer); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash).
Danish: Overaktivering af de hvide blodlegemer i forbindelse med inflammation (makrofag-aktiverings-syndrom); genopblussen af hepatitis B (en type leverbetændelse), forværring af en tilstand kaldet dermatomyositis (viser sig ved svaghed og inflammation (en betændelseslignende reaktion) i musklerne og hududslæt).
English: Detailed instructions on how to inject LIFMIOR are provided in section 7, “Using the MYCLIC pre-filled pen to inject LIFMIOR”.
Danish: Detaljeret vejledning om injektion af LIFMIOR findes i afsnit 7, ”Brug af MYCLIC fyldt pen til at injicere LIFMIOR”.
English: Diagram 4
Danish: Billede 4
English: Cartons contain 4, 8 or 24 vials of LIFMIOR with 4, 8 or 24 pre-filled solvent syringes, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs.
Danish: Æskerne indeholder 4, 8 eller 24 hætteglas LIFMIOR med 4, 8 eller 24 fyldte injektionssprøjter med solvens, 4, 8 eller 24 kanyler, 4, 8 eller 24 adaptere og 8, 16 eller 48 alkoholservietter.
English: g. Choosing an injection site
Danish: Valg af injektionssted
English: Diagram 1
Danish: Billede 1
English: • Wipe the site where LIFMIOR is to be injected with an alcohol swab, using a circular motion.
Danish: • Tør området, hvor LIFMIOR skal injiceres, af med en alkoholserviet med cirkulære bevægelser.
English: Radiographic Progression: Comparison of LIFMIOR vs. Methotrexate in Patients with RA of <3 Years Duration
Danish: RADIOGRAFISK PROGRESSION: SAMMENLIGNING AF LIFMIOR vs. METHOTREXAT HOS PATIENTER MED RA AF<3 ÅRS VARIGHED
English: 25 mg solution for injection in pre-filled syringe EU/1/16/1165/005
Danish: 25 mg injektionsvæske, opløsning i fyldt injektionssprøjte EU/1/16/1165/005
English: Withdrawing the LIFMIOR solution from the vial f.
Danish: Optrækning af LIFMIOR injektionsvæsken fra hætteglasset f.
English: In a group of 7,416 patients treated with LIFMIOR in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.
Danish: Der blev rapporteret om 18 tilfælde af lymfom hos 7.416 patienter behandlet med LIFMIOR i kliniske studier omfattende reumatoid artrit, psoriasisartrit, ankyloserende spondylitis og psoriasis.
English: How to store LIFMIOR
Danish: Sådan skal du tage LIFMIOR
English: 4 pre-filled syringes 4 alcohol swabs
Danish: 4 fyldte injektionssprøjter 4 alkoholservietter
English: In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0.54% (frequency uncommon).
Danish: I de dobbeltblinde perioder i kontrollerede kliniske studier af etanercept på tværs af alle indikationer var hyppigheden af bivirkningen 'forhøjede leverenzymer' hos patienter, der fik etanercept uden samtidig methotrexat, 0,54 % (hyppighed 'ikke almindelig').
English: Responses of Patients with Ankylosing Spondylitis in a Placebo-controlled Trial Percent of Patients
Danish: RESPONS FRA PATIENTER MED ANKYLOSERENDE SPONDYLITIS I ET PLACEBOKONTROLLERET STUDIE Procent patienter
English: Paediatric plaque psoriasis
Danish: Pædiatrisk plaque psoriasis
English: • This medicine has been prescribed for you or a child in your care.
Danish: • Lægen har ordineret LIFMIOR til dig eller dit barn.
English: 4 pre-filled syringes of 1 ml solvent 4 stainless steel injection needles 4 vial adaptors
Danish: 4 hætteglas med pulver 4 fyldte injektionssprøjter med 1 ml solvens 4 kanyler i rustfrit stål 4 hætteglasadaptere
English: 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.
Danish: Bivirkninger hos pædiatriske patienter med plaque psoriasis I et studie af 48 ugers varighed med 211 børn i alderen 4 til 17 år med pædiatrisk plaque psoriasis var de indberettede bivirkninger de samme som dem, man havde set i tidligere studier hos voksne med plaque psoriasis.