FrancophonIA/ELRC3.0 huggingface dataset:
English: Pairwise comparison p-values: * = p < 0.05 for comparisons of Enbrel vs. methotrexate, † = p < 0.05 for comparisons of Enbrel + methotrexate vs. methotrexate and φ = p < 0.05 for comparisons of Enbrel + methotrexate vs. Enbrel.
Danish: Parvis sammenligning af p-værdier: * = p < 0,05 for sammenligning af Enbrel vs. methotrexat, † = p < 0,05 for sammenligning af Enbrel + methotrexat vs. methotrexat og  = p < 0,05 for sammenligning af Enbrel + methotrexat vs. Enbrel
English: Among patients with ankylosing spondylitis who received Enbrel, 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 Enbrel, var det kliniske respons synligt på tidspunktet for første besøg (2 uger) og blev opretholdt gennem 6 måneders behandling.
English: After taking a pre-filled pen from the refrigerator, wait approximately 15-30 minutes to allow the Enbrel 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 Enbrelinjektionsvæsken i pennen opnår stuetemperatur.
English: • The three recommended injection sites for Enbrel include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 9).
Danish: • Du tre anbefalede injektionssteder for Enbrel omfatter: (1) foran midt på lårene; (2) maven, undtagen i et område på 5 cm omkring navlen; og (3) bagsiden af overarmen (se billede 9).
English: 1 Pre-filled syringe containing clear, colourless solvent (water for injections) 1 Needle
Danish: 1 Enbrel hætteglas 1 Fyldt injektionssprøjte indeholdende klar, farveløs solvens (vand til injektionsvæsker) 1 kanyle
English: Diagram 1 The MYCLIC pre-filled pen
Danish: Billede 1 MYCLIC fyldt pen
English: Contents of the pack and other information Instructions for preparing and giving an injection of Enbrel (See overleaf)
Danish: Pakningsstørrelser og yderligere oplysninger Vejledning til tilberedning og indgivelse af Enbrel
English: • Wipe the site where Enbrel is to be injected with an alcohol swab, using a circular motion.
Danish: • Tør området, hvor Enbrel skal injiceres, af med en alkoholserviet med cirkulære bevægelser.
English: After taking a syringe from the refrigerator, wait approximately 15-30 minutes to allow the Enbrel 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 Enbrelinjektionsvæsken i sprøjten opnår stuetemperatur.
English: METHOD OF ADMINISTRATION
Danish: ANVENDELSESMETODE
English: • Select a clean, well-lit, flat working surface.
Danish: • Vælg en ren, godt belyst, flad arbejdsflade.
English: CARTON TEXT - EU/1/99/126/022 (For paediatric use)
Danish: YDERKARTON - EU/1/99/126/022 (Til pædiatrisk brug)
English: • With a quick, short motion, push the needle all the way into the skin at an angle between 45° and 90° (see Diagram 10).
Danish: • Pres kanylen helt ind i huden med en hurtig, kort bevægelse i en vinkel mellem 45 og 90 (se billede 10).
English: The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study.
Danish: Enbrels effekt blev vurderet i en randomiseret, dobbelt-blind, placebokontrolleret studie.
English: Detailed instructions on how to inject Enbrel are provided in section 7, “Using the MYCLIC pre-filled pen to inject Enbrel”.
Danish: Detaljeret vejledning om injektion af Enbrel findes i afsnit 7, ”Brug af MYCLIC fyldt pen til at injicere Enbrel”.
English: Enbrel is recommended for use in patients as defined in section 4.1.
Danish: Patienter, som Enbrel anbefales til er defineret i pkt.
English: Doses of 10 mg or 25 mg Enbrel 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: 2 pre-filled syringes 2 alcohol swabs
Danish: 2 fyldte injektionssprøjter 2 alkoholservietter
English: The three recommended injection sites for Enbrel using a pre-filled syringe include: (1) the front of the middle thighs; (2) the abdomen, except for the 5 cm area right around the navel; and (3) the outer area of the upper arms (see Diagram 1).
Danish: De tre anbefalede injektionssteder for Enbrel fyldt injektionssprøjte omfatter: (1) foran midt på lårene; (2) maven, undtagen i et område på 5 cm omkring navlen; og (3) bagsiden af overarmen (se billede 1).
English: Serious adverse reactions have also been reported for Enbrel.
Danish: Alvorlige og dødelige infektioner er blevet rapporteret ved brug af Enbrel.
English: Contents of the pack and other information Using the MYCLIC pre-filled pen to inject Enbrel (See overleaf)
Danish: Pakningsstørrelser og yderligere oplysninger Brug af MYCLIC fyldt pen til at injicere Enbrel
English: Enbrel 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: Enbrel pulver og solvens til injektionsvæske, opløsning, til pædiatrisk brug leveres som et hvidt pulver og solvens til opløsning til injektion (pulver til injektion).
English: (n = 231) a: Patients who did not complete 12 months in the study were considered to be non-responders.
Danish: Uge 52 a: Patienter, som ikke gennemførte 12 måneder af studiet, blev betragtet som ikkeresponderende.
English: Again, do not touch the needle or allow it to touch any surface.
Danish: Sørg igen for ikke at berøre kanylen, og sørg for, at den ikke berører nogen overflader.
English: In part 1 of the study, 51 of 69 (74%) patients demonstrated a clinical response and entered part 2.
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 Enbrel, sygdomsopblussen sammenlignet med 20 af
English: What Enbrel contains
Danish: Enbrel indeholder:
English: Setting up for an injection
Danish: Forberedelse til injektion
English: Before injection, Enbrel single-use pre-filled pens should be allowed to reach room temperature (approximately 15 to 30 minutes).
Danish: Instruktioner vedrørende anvendelse og håndtering Før injektion bør Enbrel engangs fyldte penne opnå stuetemperatur (ca. 15-30 minutter).
English: Gather the items that you will need for your injection, and place them on the chosen surface: a. One MYCLIC pre-filled pen and one alcohol swab (take these from the carton of pens you keep in your refrigerator).
Danish: En MYCLIC fyldt pen og en alkoholserviet (tages fra æsken med penne i køleskabet).
English: In a group of 7,416 patients treated with Enbrel 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 Enbrel i kliniske studier omfattende reumatoid artrit, psoriasisartrit, ankyloserende spondylitis og psoriasis.
English: 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.
Danish: 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 studier af Enbrel og methotrexat alene.
English: Each pack contains 4, 8 or 24 pens and 4, 8 or 24 alcohol swabs.
Danish: Hver pakke indeholder 4, 8 eller 24 penne og 4, 8 eller 24 alkoholservietter.
English: 70b a: 25 mg Enbrel SC twice weekly b: p < 0.001, Enbrel vs. placebo c: p < 0.01, Enbrel vs. placebo
Danish: a: 25 mg Enbrel subkutant to gange om ugen b: p < 0,001, Enbrel vs. placebo c: p < 0,01, Enbrel vs. placebo
English: In a controlled clinical trial of two years duration in 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.
Danish: I en kontrolleret klinisk afprøvning af to års varighed med 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 studier af Enbrel og methotrexat alene.
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: Radiographic Progression: Comparison of Enbrel vs. Methotrexate vs. Enbrel in Combination with Methotrexate in Patients with RA of 6 Months To 20 Years Duration (12 Month Results)
Danish: RADIOGRAFISK PROGRESSION: SAMMENLIGNING AF ENBREL vs. METHOTREXAT vs. ENBREL I KOMBINATION MED METHOTREXAT HOS PATIENTER MED REUMATOID ARTRIT AF 6 MÅNEDER TIL 20 ÅRS VARIGHED (12 MÅNEDERS RESULTER)
English: Comprehensive instructions for administration are given in the package leaflet, section 7, "Using the MYCLIC pre-filled pen to inject Enbrel."
Danish: Detaljeret vejledning om indgivelse findes i indlægssedlen, afsnit 7, ”Brug af MYCLIC fyldt pen til at injicere Enbrel”.
English: • Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Enbrel.
Danish: • Skoldkopper: Fortæl det til lægen, hvis du eller barnet bliver udsat for skoldkopper under behandlingen med Enbrel.
English: TEXT FOR PRE-FILLED SYRINGE LABEL - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg Pre-filled Syringe)
Danish: ETIKET TIL FYLDT INJEKTIONSSPRØJTE - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg fyldt injektionssprøjte)
English: Pre-filled pen (MYCLIC) containing a 25 mg pre-filled syringe of Enbrel.
Danish: Fyldt pen (MYCLIC) indeholdende en 25 mg fyldt sprøjte med Enbrel.
English: 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, placebocontrolled study of 356 patients with active ankylosing spondylitis.
Danish: I et fjerde studie 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 et dobbeltblindt, placebo-kontrolleret studie med 356 patienter med aktiv ankyloserende spondylitis.
English: Radiographic Progression: Comparison of Enbrel vs. Methotrexate in Patients with RA of <3 Years Duration
Danish: RADIOGRAFISK PROGRESSION: SAMMENLIGNING AF ENBREL vs. METHOTREXAT HOS PATIENTER MED RA AF<3 ÅRS VARIGHED
English: Enbrel 50 mg solution for injection in pre-filled syringe Clear glass syringe (type I glass) with stainless steel needle, rubber needle cover and plastic plunger.
Danish: Enbrel 50 mg injektionsvæske, opløsning i fyldt injektionssprøjte Klar glassprøjte (type I glas) med rustfri stålkanyle, gummi nålehætte og plastikstempel.
English: Method of administration Enbrel is administered by subcutaneous injection (see section 6.6).
Danish: Indgivelsesmåde Enbrel indgives ved subkutan injektion (se pkt.
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: 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: Enbrel 25 mg solution for injection in pre-filled syringe Clear glass syringe (type I glass) with stainless steel needle, rubber needle cover and plastic plunger.
Danish: Enbrel 25 mg injektionsvæske, opløsning i fyldt injektionssprøjte Klar glassprøjte (type I glas) med rustfri stålkanyle, gummi nålehætte og plastikstempel.
English: CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis (see section 4.4), peripheral demyelinat ing event s, including GuillainBarré syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropat hy, and multifocal motor neuropathy (see section 4.4), seizure
Danish: Perifere demyeliniserend e hændelser herunder Guillain-Barrés syndrom, kronisk inflammatorisk demyeliniserend e polyneuropati, demyeliniserend e polyneuropati og multifokal motorisk neuropati (se pkt 4.4), anfald
English: Clinical Efficacy Results at 12 Months: Comparison of Enbrel vs. Methotrexate vs. Enbrel 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 ENBREL vs. METHOTREXAT vs. ENBREL I KOMBINATION MED METHOTREXAT HOS PATIENTER MED REUMATOID ARTRIT AF 6 MÅNEDER TIL 20 ÅRS VARIGHED
English: Opportunistic infections have been reported in association with Enbrel, 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 Enbrel, herunder invasive svampeinfektioner samt parasitinfektion (herunder forårsaget af protozoer), virale (inkl.
English: Preparing the injection site and injecting the Enbrel solution
Danish: Forberedelse af injektionssted og injektion af Enbrel injektionsvæsken
English: The safety and efficacy of 50 mg Enbrel (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 Enbrel (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: • Chickenpox: Tell your doctor if the child is exposed to chickenpox when using Enbrel.
Danish: • Skoldkopper: Fortæl det til lægen, hvis barnet bliver udsat for skoldkopper under behandlingen med Enbrel.
English: The efficacy of Enbrel 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
Danish: Effekten af Enbrel 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: Pfizer Kft. Tel: +36 1 488 3700
Danish: Tel: +36 1 488 3700
English: For rheumatoid arthritis, Enbrel is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you.
Danish: Enbrel anvendes oftest i kombination med methotrexat til behandling af reumatoid artrit.
English: 1 Vial adaptor
Danish: 1 adapter 2 alkoholservietter
English: You will also need 1 ml of water for injections and a syringe to administer Enbrel 16.
Danish: For at injicere Enbrel behøver du også 1 ml vand til injektionsvæsker og en injektionssprøjte.
English: Pre-filled pen (MYCLIC) containing a 50 mg pre-filled syringe of Enbrel.
Danish: Fyldt pen (MYCLIC) indeholdende en 50 mg fyldte sprøjte med Enbrel.
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 plasticlåg til at skubbe af.
English: Pairwise comparison p-values: † = p < 0.05 for comparisons of Enbrel + methotrexate vs methotrexate and φ = p < 0.05 for comparisons of Enbrel + methotrexate vs Enbrel
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: If this is the case, start again with another vial.
Danish: Begynd igen med et andet glas, hvis dette ikke er tilfældet.
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: Baseline scoreb Week 52 scoreb
Danish: Baseline Uge 52
English: CARTON TEXT - EU/1/99/126/016-018 (50 mg Pre-filled Syringe)
Danish: YDERKARTON - EU/1/99/126/016-018 (50 mg fyldt injektionssprøjte)
English: Do not use this medicine after the expiry date which is stated on the carton and on the MYCLIC prefilled 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: The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg administered once weekly.
Danish: Den anbefalede dosis er 25 mg Enbrel indgivet to gange om ugen eller 50 mg indgivet én gang om ugen.
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: Enbrel 25 mg solution for injection in pre-filled syringe Enbrel is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown solution for injection (solution for injection).
Danish: Enbrel 25 mg injektionsvæske, opløsning i fyldt injektionssprøjte Enbrel leveres som en fyldt injektionssprøjte, der indeholder en klar, farveløs til svagt gul eller lysebrun opløsning til injektion.
English: Pfizer Luxembourg SARL filiāle Latvijā
Danish: Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
English: Enbrel 50 mg solution for injection in pre-filled syringe Enbrel is supplied as a pre-filled syringe containing a clear, colourless to pale yellow or pale brown solution for injection (solution for injection).
Danish: Enbrel 50 mg injektionsvæske, opløsning i fyldt injektionssprøjte Enbrel leveres som en fyldt injektionssprøjte, der indeholder en klar, farveløs til svagt gul eller lysebrun opløsning til injektion.
English: CARTON TEXT - EU/1/99/126/023-025 (25 mg Pre-filled Pen)
Danish: YDERKARTON - EU/1/99/126/023-025 (25 mg fyldt pen)
English: Do not inject into tender, bruised or hard skin.
Danish: Du må ikke injicere på et område, hvor huden er øm, stødt eller hård.
English: • Allergic reactions: If the child experiences allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, 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 Enbrel, og du skal straks kontakte lægen.
English: Powder: Mannitol, sucrose and trometamol.
Danish: De andre indholdsstoffer i Enbrel er: Pulver: Mannitol, saccharose og trometamol
English: • Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Enbrel, 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 Enbrel, og du skal straks kontakte lægen.
English: CARTON TEXT - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg Pre-filled Syringe)
Danish: YDERKARTON - EU/1/99/126/013-015, EU/1/99/126/026 (25 mg fyldt injektionssprøjte)
English: CARTON TEXT - EU/1/99/126/019-021 (50 mg Pre-filled Pen)
Danish: YDERKARTON - EU/1/99/126/019-021 (50 mg fyldt pen)
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 bleg gul eller lysebrun, uden klumper, flager eller partikler.
English: • With the needle still in the vial, hold the vial upside down at eye level.
Danish: • Mens kanylen stadig sidder i glasset, skal hætteglasset holdes, således at glasset vender på hovedet i øjenhøjde.
English: New onset cardiac failure congestive (see section 4.4)
Danish: motorisk neuropati (se pkt 4.4), anfald
English: 12 pre-filled syringes 12 alcohol swabs
Danish: 12 fyldte injektionssprøjter 12 alkoholservietter
English: NEVER re-cap a needle.
Danish: Sæt aldrig hætten tilbage på kanylen.
English: Cartons contain 4, 8 or 24 vials of Enbrel 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 Enbrel 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.Ikke nødvendigvis alle pakningsstørrelser markedsføres.
English: Among patients with plaque psoriasis who received Enbrel, 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 Enbrel, var der ved første besøg (2 uger) signifikant respons sammenlignet med placebo.
English: Enbrel may be stored 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: Enbrel kan opbevares ved temperaturer op til højst 25 C i en enkelt periode på op til 4 uger, hvorefter det ikke må nedkøles igen.
English: How to store Enbrel
Danish: Sådan skal du tage Enbrel
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22
Danish: Efter markedsføring er der rapporteret om maligniteter, heraf nogle letale, hos børn, unge og unge voksne (op til 22 år), der er behandlet med TNF-antagonister (start på behandling ≤ 18 år), herunder
English: Enbrel 25 mg injection etanercept
Danish: Enbrel 25 mg injektionsvæske Etanercept
English: Before preparing the Enbrel solution, Enbrel 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 Enbrel klargøres, kan Enbrel 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: Enbrel 25 mg solution for injection in pre-filled pen Enbrel 50 mg solution for injection in pre-filled pen
Danish: Enbrel 25 mg injektionsvæske, opløsning i fyldt pen Enbrel 50 mg injektionsvæske, opløsning i fyldt pen
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 bleg gul eller lysebrun, uden klumper, flager eller partikler.
English: EU/1/99/126/016 2 pre-filled syringes EU/1/99/126/017 4 pre-filled syringes EU/1/99/126/018 12 pre-filled syringes
Danish: EU/1/99/126/016 2 fyldte injektionssprøjter EU/1/99/126/017 4 fyldte injektionssprøjter EU/1/99/126/018 12 fyldte injektionssprøjter