FrancophonIA/ELRC3.0 huggingface dataset:
English: Each pack contains 4, 8 or 24 single dose vials, 4, 8 or 24 pre-filled syringes of water for injections, 4, 8 or 24 needles, 4, 8 or 24 vial adaptors and 8, 16 or 48 alcohol swabs.
Danish: Hver pakke indeholder 4, 8 eller 24 enkeltdosis hætteglas, 4, 8 eller 24 fyldte injektionssprøjter med vand til injektionsvæsker, 4, 8 eller 24 kanyler, 4, 8 eller 24 hætteglasadaptere og 8, 16 eller 48 alkoholservietter.
English: Paediatric patients with plaque psoriasis
Danish: Pædiatriske patienter med plaque psoriasis
English: 6.5 Nature and contents of container
Danish: 6.5 Emballagetype og pakningstørrelser
English: Powder: Mannitol (E421), sucrose, and trometamol.
Danish: Øvrige indholdsstoffer: Pulver: Mannitol (E421), saccharose og trometamol
English: 10 mg or 25 mg LIFMIOR were administered SC twice a week for up to 24 months.
Danish: Doser á 10 mg eller 25 mg blev administreret subkutant to gange om ugen i op til 24 måneder.
English: The solution should be clear and colourless to pale yellow or pale brown, with no lumps, flakes or particles.
Danish: Opløsningen skal være klar og farveløs til svagt gul eller lysebrun, uden klumper, flager eller partikler.
English: In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of autoimmune hepatitis was 0.24% (frequency uncommon).
Danish: I kontrollerede studier, der tillod samtidig behandling med etanercept og methotrexat, var hyppigheden af autoimmun hepatitis 0,24 % (hyppighed 'ikke almindelig').
English: Solution for injection.
Danish: Forberedelse til injektion
English: • Teaching guide to facilitate training of the patients in the safe use of the pre-filled pen
Danish: Sundhedspersonalets uddannelsesmateriale skal indeholde følgende hovedelementer: Undervisningsguide til at lette træningen af patienterne i sikker brug af den fyldte pen Et demonstrationsdevice/apparat uden kanyle Instruktionsmaterial, som kan uddeles til patienter
English: LIFMIOR is recommended for use in patients as defined in section 4.1.
Danish: Patienter, som LIFMIOR anbefales til er defineret i pkt.
English: 70b a: 25 mg LIFMIOR SC twice weekly b: p < 0.001, LIFMIOR vs. placebo c: p < 0.01, LIFMIOR vs. placebo
Danish: a: 25 mg LIFMIOR subkutant to gange om ugen b: p < 0,001, LIFMIOR vs. placebo c: p < 0,01, LIFMIOR vs. placebo
English: Study 2
Danish: Billede 2
English: The dose should be 25 mg twice weekly or 50 mg once weekly.
Danish: Dosis bør være 25 mg to gange om ugen eller 50 mg én gang om ugen.
English: You will be instructed by the child's doctor or his/her assistant on the technique of giving an injection and on the amount to be given to the child. Do not attempt to administer an injection until you are sure that you understand how to prepare and give the injection.
Danish: Dit barns læge eller hans/hendes assistent vil instruere dig i, hvordan man giver en injektion, og hvilken mængde der skal gives til barnet.
English: Study 3
Danish: Billede 3
English: • Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using LIFMIOR.
Danish: • Skoldkopper: Fortæl det til lægen, hvis du eller barnet bliver udsat for skoldkopper under behandlingen med LIFMIOR.
English: Opportunistic infections have been reported in association with LIFMIOR, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
Danish: Der er rapporteret om opportunistiske infektioner i forbindelse med LIFMIOR, herunder invasive svampeinfektioner samt parasitinfektion (herunder forårsaget af protozoer), virale (inkl.
English: The solution should be clear, colourless to pale yellow or pale brown, with no lumps or flakes or particles.
Danish: Opløsningen skal være klar, farveløs til svagt gul eller lysebrun, uden klumper, flager eller partikler.
English: • Severe psoriasis in patients from the age of 6 years who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies.
Danish: • Svær psoriasis hos patienter fra 6 års-alderen, hvor responset på lysbehandling eller systemisk behandling har været utilstrækkeligt, eller du ikke har kunnet anvende dem.
English: • Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years
Danish: • Polyartrit (ledbetændelse i 5 eller flere led) (reumafaktor-positiv eller -negativ) og udvidet oligoartrit (ledbetændelse i 2-4 led de første 6 måneder af sygdommen, men med senere øgning til 5 eller flere led) hos patienter fra 2 år.
English: Method and route of administration
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Using the MYCLIC pre-filled pen to inject LIFMIOR."
Danish: Detaljeret vejledning om indgivelse findes i indlægssedlen, afsnit 7, ”Brug af MYCLIC fyldt pen til at injicere LIFMIOR”.
English: INFORMATION IN BRAILLE LIFMIOR 10 mg
Danish: LIFMIOR 10 mg
English: • Remove the contents of the tray
Danish: • Tag indholdet ud af bakken.
English: • Chickenpox: Tell your doctor if the child is exposed to chickenpox when using LIFMIOR.
Danish: • Skoldkopper: Fortæl det til lægen, hvis barnet bliver udsat for skoldkopper under behandlingen med LIFMIOR.
English: Do not use this medicine after the expiry date which is stated on the carton and on the MYCLIC pre-filled pen after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og på MYCLIC fyldt pen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of interstitial lung disease in patients receiving etanercept without concomitant methotrexate was 0.06% (frequency rare).
Danish: I kontrollerede kliniske studier med etanercept på tværs af alle indikationer var hyppigheden af interstitiel lungesygdom hos patienter, der fik etanercept uden samtidig methotrexat, 0,06 % (hyppighed 'sjælden').
English: Pairwise comparison p-values: † = 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 etanercept + methotrexat vs. methotrexat og  = p < 0,05 for sammenligning af etanercept + methotrexat vs. Etanercept
English: In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of autoimmune hepatitis in patients receiving etanercept without concomitant methotrexate was 0.02% (frequency rare).
Danish: I kontrollerede kliniske studier af etanercept på tværs af alle indikationer var hyppigheden af autoimmun hepatitis hos patienter, der fik etanercept uden samtidig methotrexat, 0,02 % (hyppighed 'sjælden').
English: For rheumatoid arthritis, LIFMIOR is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you.
Danish: LIFMIOR anvendes oftest i kombination med methotrexat til behandling af reumatoid artrit.
English: Patients aged 4 to 17 years with moderately to severely active polyarticular-course juvenile idiopathic arthritis refractory to, or intolerant of, methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal anti-inflammatory drug and/or prednisone (< 0.2 mg/kg/day or 10 mg maximum).
Danish: Patienterne fik fortsat en stabil dosis af et enkelt nonsteroidt anti-inflammatorisk præparat og/eller prednison (<0,2 mg/kg/dag eller maksimum 10 mg).
English: CARTON TEXT - (50 mg Pre-filled Pen) - EU/1/16/1165/011-013
Danish: YDERKARTON - (50 mg fyldt pen) - EU-1/16/1165/011-013
English: Step 3: Injecting the LIFMIOR solution
Danish: Trin 3: Injektion af LIFMIOR-injektionsvæsken
English: The safety and efficacy of 50 mg LIFMIOR (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA.
Danish: Sikkerhed og effekt af 50 mg LIFMIOR (to gange 25 mg subkutan injektion) indgivet en gang om ugen blev undersøgt i et dobbeltblindt, placebo-kontrolleret studie med 420 patienter med aktiv reumatoid artrit.
English: Responses of Patients with Psoriatic Arthritis in a Placebo-Controlled Trial Percent of Patients Placebo
Danish: RESPONS HOS PATIENTER MED PSORIASISARTRIT I PLACEBO-KONTROLLEREDE FORSØG % af patienter Placebo LIFMIOR
English: Responses of Patients with Psoriatic Arthritis in a PlaceboControlled Trial Percent of Patients Placebo
Danish: RESPONS HOS PATIENTER MED PSORIASISARTRIT I PLACEBOKONTROLLEREDE FORSØG % af patienter Placebo LIFMIOR
English: DAS Baseline scoreb Week 52 scoreb
Danish: Baseline Uge 52
English: Diagram 6
Danish: Billede 6
English: Check with your doctor if or pharmacist you are not sure.
Danish: Spørg din læge eller apotekspersonalet, hvis der er noget du er i tvivl om.
English: 12b
Danish: BILAG I
English: The recommended dose is 25 mg LIFMIOR administered twice weekly, or 50 mg administered once weekly.
Danish: Den anbefalede dosis er 25 mg LIFMIOR indgivet to gange om ugen eller 50 mg indgivet én gang om ugen.
English: b. One cotton ball or gauze
Danish: Et stykke vat eller gaze.
English: Each pack contains 4, 8 or 24 pre-filled syringes and 4, 8 or 24 alcohol swabs.
Danish: Hver pakke indeholder 4, 8 eller 24 fyldte injektionssprøjter og 4, 8 eller 24 alkoholservietter.
English: Disposing of supplies a. Introduction
Danish: Bortskaffelse af udstyr a.
English: You will be instructed by your doctor or his/her assistant on the techniques of self-injection or on giving an injection to a child. Do not attempt to administer an injection until you are sure that you understand how to prepare and give the injection.
Danish: Læs vejledningen grundigt, og følg den trin for trin. Din læge eller hans/hendes assistent vil instruere dig i at injicere dig selv eller i at give en injektion til et barn.
English: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including GuillainBarré syndrome, chronic inflammatory
Danish: CNSdemyeliniserings tilfælde som antyder multipel sklerose eller lokaliserede demyeliniserings forhold som for eksempel opticusneuritis og transversel myelitis (se pkt
English: Each pack contains 4 vials, 4 pre-filled syringes of water for injections, 4 needles, 4 vial adaptors and 8 alcohol swabs.
Danish: Hver pakke indeholder 4 hætteglas, 4 fyldte injektionssprøjter med solvens 4 kanyler, 4 hætteglasadaptorer og 8 alkoholservietter.
English: • Rare (may affect up to 1 in 1,000 people):
Danish: • Sjælden (forekommer hos mellem 1 og 10 ud af 10.000 personer):
English: • For enthesitis-related arthritis in patients from the age of 12 years when other widely used treatments have not worked well enough or are not suitable for them
Danish: • enthesitis-relateret artrit (gigt associeret med inflammation af sener og disses tilhæftningssteder) hos patienter fra 12 år, når anden behandling har været utilstrækkelig eller ikke kan anvendes.
English: • If the child has psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“psoriasis skin lesions”).
Danish: • Hvis barnet har psoriasis, skal du ikke forsøge at injicere direkte ind i hudområder, der er hævede, hårde, røde eller skællede (”psoriasis hudlæsioner”).
English: LIFMIOR 25 mg solution for injection in pre-filled syringe LIFMIOR 50 mg solution for injection in pre-filled syringe
Danish: LIFMIOR 25 mg injektionsvæske, opløsning i fyldt injektionssprøjte LIFMIOR 50 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: By looking though the inspection window, the solution should be clear to slightly opalescent, colourless to pale yellow or pale brown, and may contain small translucent or white particles of protein.
Danish: Se gennem inspektionsvinduet at opløsningen er klar til svagt opaliserende, farveløs til svagt gul eller lysebrun og muligvis indeholder små, gennemsigtige eller hvide proteinpartikler.
English: Each MYCLIC pre-filled pen contains 50 mg of etanercept.
Danish: Hver MYCLIC fyldt pen indeholder 50 mg etanercept.
English: h. Preparing the injection site and injecting the LIFMIOR solution
Danish: Forberedelse af injektionssted og injektion af LIFMIOR injektionsvæsken
English: A 25 mg strength of LIFMIOR is available for doses of 25 mg.
Danish: Du har fået en recept på LIFMIOR i styrken 50 mg. Der findes en styrke på 25 mg LIFMIOR til doser på 25 mg.
English: 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: Patienter i grupperne med aktiv behandling fortsatte til uge 24 på den dosis, de oprindeligt blev randomiseret til.
English: In a fourth study, the safety and efficacy of 50 mg LIFMIOR (two 25 mg SC injections) administered once weekly vs 25 mg LIFMIOR administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
Danish: I et fjerde studie blev sikkerhed og effekt af 50 mg LIFMIOR (to gange 25 mg subkutane injektioner) indgivet en gang om ugen versus 25 mg LIFMIOR indgivet to gange om ugen vurderet i et dobbeltblindt, placebo-kontrolleret studie med 356 patienter med aktiv ankyloserende spondylitis.
English: The solution is clear, and colourless to pale yellow or pale brown.
Danish: Opløsningen er klar, og farveløs til svagt gul eller lysebrun .
English: • Allergic reactions: If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately.
Danish: • Allergiske reaktioner: Hvis barnet får allergiske reaktioner som f.eks. trykken for brystet, hiven efter vejret, svimmelhed eller udslæt, må du ikke injicere mere LIFMIOR, og du skal straks kontakte lægen.
English: • If you or the child have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“psoriasis skin lesions”).
Danish: • Hvis du eller barnet har psoriasis, skal du ikke forsøge at injicere direkte ind i hudområder, der er hævede, hårde, røde eller skællede (”psoriasis hudlæsioner”).
English: • Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more LIFMIOR, and contact your doctor immediately.
Danish: • Allergiske reaktioner: Hvis du eller barnet får allergiske reaktioner som f.eks. trykken for brystet, hiven efter vejret, svimmelhed eller udslæt, må du ikke injicere mere LIFMIOR, og du skal straks kontakte lægen.
English: 50 mg BIW
Danish: 50 mg 50 mg
English: LIFMIOR 0.8 mg/kg Once Weekly (N = 106)
Danish: 1 gang om ugen (N = 106)
English: If you or the child have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin patches (“psoriasis skin lesions”).
Danish: Hvis du eller dit barn har psoriasis, skal du ikke forsøge at injicere direkte ind i hudområder, der er hævede, hårde, røde eller skællede (”psoriasis hudlæsioner”).
English: 50 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 50 mg of etanercept.
Danish: 50 mg injektionsvæske, opløsning i fyldt injektionssprøjte Hver fyldt injektionssprøjte indeholder 50 mg etanercept.
English: Radiographic Progression: Comparison of LIFMIOR vs. Methotrexate vs. LIFMIOR in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration (12 Month Results)
Danish: RADIOGRAFISK PROGRESSION: SAMMENLIGNING AF LIFMIOR vs. METHOTREXAT vs. LIFMIOR I KOMBINATION MED METHOTREXAT HOS PATIENTER MED REUMATOID ARTRITAF 6 MÅNEDER TIL 20 ÅRS VARIGHED (12 MÅNEDERS RESULTER)
English: Before preparing the LIFMIOR solution, LIFMIOR may be stored outside of the refrigerator at temperatures up to a maximum of 25°C for a single period of up to four weeks; after which, it should not be refrigerated again.
Danish: Før LIFMIOR klargøres, kan LIFMIOR opbevares uden for køleskab ved temperaturer op til højst 25 C i en enkelt periode på op til 4 uger, hvorefter det ikke må nedkøles igen.
English: Clinical Efficacy Results at 12 Months: Comparison of LIFMIOR vs. Methotrexate vs. LIFMIOR in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration
Danish: RESULTER FOR KLINISK EFFEKT EFTER 12 MÅNEDER: SAMMENLIGNING AF LIFMIOR vs. METHOTREXAT vs. LIFMIOR I KOMBINATION MED METHOTREXAT HOS PATIENTER MED REUMATOID ARTRIT AF 6 MÅNEDER TIL 20 ÅRS VARIGHED
English: 25 mg solution for injection in pre-filled syringe Each pre-filled syringe contains 25 mg of etanercept.
Danish: 25 mg injektionsvæske, opløsning i fyldt injektionssprøjte Hver fyldt injektionssprøjte indeholder 25 mg etanercept.
English: Each pack contains 2, 4 or 12 pre-filled syringes and 2, 4 or 12 alcohol swabs.
Danish: Hver pakke indeholder 2, 4 eller 12 fyldte injektionssprøjter og 2, 4 eller 12 alkoholservietter.
English: In the controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of interstitial lung disease was 0.47% (frequency uncommon).
Danish: I de kontrollerede kliniske studier, der tillod samtidig behandling med etanercept og methotrexat, var hyppigheden af interstitiel lungesygdom 0,47 % (hyppighed 'ikke almindelig').
English: CARTON TEXT - (25 mg Pre-filled Syringe) - EU/1/16/1165/005-007
Danish: YDERKARTON (25 mg fyldt injektionssprøjte) - EU/1/16/1165/005-007
English: Method of administration LIFMIOR is administered by subcutaneous injection (see section 6.6).
Danish: Indgivelsesmåde LIFMIOR indgives ved subkutan injektion (se pkt.
English: Each vial of LIFMIOR 25 mg contains 25 mg of etanercept.
Danish: Hvert hætteglas LIFMIOR 25 mg indeholder 25 mg etanercept.
English: Among patients with plaque psoriasis who received LIFMIOR, significant responses relative to placebo were apparent at the time of the first visit (2 weeks) and were maintained through 24 weeks of therapy.
Danish: Hos patienter med plaque psoriasis, som blev behandlet med LIFMIOR, var der ved første besøg (2 uger) signifikant respons sammenlignet med placebo.
English: Each vial contains 10 mg of etanercept.
Danish: Hvert hætteglas indeholder 10 mg etanercept.
English: Each pre-filled pen contains 50 mg of etanercept.
Danish: Hver fyldt pen indeholder 50 mg etanercept.
English: ASAS 20 2 weeks
Danish: 2 x uge 2 x uge
English: If you have psoriasis, you should try not to inject directly into any raised, thick, red, or scaly skin.
Danish: • Hvis du har psoriasis, bør du undgå at injicere direkte ind i hudområder, der er hævede, hårde, røde eller skællede.
English: (If not, don't use the dose tray and consult your pharmacist).
Danish: • Dosisbakken skal indeholde nedenstående ting (hvis dette ikke er tilfældet, skal du ikke benytte dosisbakken, men i stedet kontakte dit apotek).
English: ASAS 70: 2 weeks
Danish: ASAS 70 :
English: Radiographic Progression: Comparison of LIFMIOR vs Methotrexate vs LIFMIOR in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration (12 Month Results)
Danish: RADIOGRAFISK PROGRESSION: SAMMENLIGNING AF LIFMIOR vs. METHOTREXAT vs. LIFMIOR I KOMBINATION MED METHOTREXAT HOS PATIENTER MED REUMATOID ARTRIT AF 6 MÅNEDER TIL 20 ÅRS VARIGHED (12 MÅNEDERS RESULTER)
English: Inspect the solution in the syringe.
Danish: Kontroller injektionsvæsken i sprøjten.
English: With your free hand, hold the syringe near its base to stabilise it. Then push the plunger to inject all of the solution at a slow, steady rate (see Diagram 19).
Danish: Pres så stemplet ind for at injicere al injektionsvæsken med en langsom og jævn hastighed (se billede 19).
English: The LIFMIOR solution should not be mixed with any other medicine before use.
Danish: LIFMIOR injektionsvæsken må ikke blandes med anden medicin.
English: Waiting until the solution reaches room temperature may make the injection more comfortable for you.
Danish: Det kan gøre injektionen mere behageligt for dig, hvis du lader injektionsvæsken opnå stuetemperatur.
English: 25 mg BIW
Danish: 25 mg 50 mg
English: CARTON TEXT - (50 mg Pre-filled Syringe) - EU/1/16/1165/008-010
Danish: YDERKARTON - (50 mg fyldt injektionssprøjte) - EU/1/16/1165/008-010
English: In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients.
Danish: Bivirkninger hos pædiatriske patienter med juvenil idiopatisk artrit Generelt var bivirkningerne hos de pædiatriske patienter med juvenil idiopatisk artrit af samme hyppighed og type som dem, man så hos voksne patienter.
English: Adult patients with psoriatic arthritis
Danish: Voksne patienter med psoriasisartrit
English: Cartons contain 4, 8 or 24 pre-filled syringes of LIFMIOR and 4, 8 or 24 alcohol swabs.
Danish: Æskerne indeholder 4, 8 eller 24 fyldte injektionssprøjter med LIFMIOR og 4, 8 eller 24 alkoholservietter.
English: LIFMIOR 25 mg powder and solvent for solution for injection.
Danish: LIFMIOR 25 mg pulver og solvens til injektionsvæske, opløsning.
English: Each pre-filled syringe contains 1.0 ml of solution, providing 50 mg of etanercept.
Danish: Hver fyldt injektionssprøjte indeholder 1,0 ml injektionsvæske, der rummer 50 mg etanercept.
English: Each vial of LIFMIOR contains 10 mg etanercept.
Danish: Hvert hætteglas LIFMIOR indeholder 10 mg etanercept.
English: Each pre-filled syringe contains 0.5 ml of solution, providing 25 mg of etanercept.
Danish: Hver fyldt injektionssprøjte indeholder 0,5 ml injektionsvæske, der rummer 25 mg etanercept.
English: Do NOT shake the vial.
Danish: Ryst IKKE hætteglasset.
English: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinating events, including GuillainBarré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy (see section 4.4), seizure
Danish: Perifere demyeliniserende hændelser herunder Guillain-Barrés syndrom, kronisk inflammatorisk demyeliniserend e polyneuropati, demyeliniserend e polyneuropati og multifokal motorisk neuropati (se pkt 4.4), anfald
English: Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common).
Danish: • Ikke almindelig (forekommer hos mellem 1 og 10 ud af 1.000 personer): Alvorlige infektioner (herunder lungebetændelse, dybe hudinfektioner, ledinfektioner, blodinfektion og infektioner andre steder), forværring af hjerteinsufficiens (hjertesvigt), lavt antal røde blodceller, lavt antal hvide blodceller, lavt antal neutrofiler (en type hvide blodceller), lavt antal blodplader, hudkræft (ikke melanom), lokal opsvulmen af huden (angioødem), nældefeber (hævede pletter af rød eller bleg hud, som ofte klør), betændelse i øjet, psoriasis (nyopstået eller forværret), inflammation (betændelsesagtig tilstand) i blodkarrene, hvilket kan påvirke flere organer, forhøjede tal for leverfunktion i blodprøver (hos patienter, der også får behandling med methotrexat, er hyppigheden af forhøjede tal for leverfunktion i blodprøver almindelig).
English: • With the vial held upside down, unscrew the syringe from the vial adaptor by turning it anti-clockwise (see Diagram 12).
Danish: • Hold hætteglasset på hovedet og skru sprøjten af adapteren ved at dreje den mod uret (se billede