FrancophonIA/ELRC3.0 huggingface dataset:
English: In study UC-II, among those treated with adalimumab who were in remission at week 8, 21/41 (51%) were in remission at week 52.
Danish: I studie UC-II var 21/41 (51 %) af de adalimumab-behandlede patienter, der var i remission i uge 8, også i remission i uge 52.
English: SOLYMBIC is contraindicated in moderate to severe heart failure (see section 4.3).
Danish: SOLYMBIC kontraindikeres ved moderat til alvorlig hjerteinsufficiens (se pkt.
English: Children with enthesitis-related arthritis
Danish: Børn med entesopati-relateret artrit
English: Adequate data from treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Danish: Der foreligger ikke tilstrækkelige data fra anti-viral behandling i kombination med TNF-antagonister for at forebygge HBV-reaktivering hos patienter, som er bærere af.
English: Children or adolescents with Crohn's disease
Danish: Børn og unge med Crohns sygdom
English: Table 10 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Danish: Tabel 10. ACR-respons i placebokontrollerede psoriasisartrit-studier (procentdel af patienter)
English: Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Danish: Anvendelse af adalimumab til patienter under 6 år med entesopati-relateret artrit er ikke undersøgt.
English: Do not use the 20 mg or 40 mg pre-filled syringe if doses other than 20 mg or 40 mg are recommended.
Danish: - Brug ikke injektionssprøjten med 20 mg eller 40 mg, hvis en anden dosis end 20 mg eller 40 mg er anbefalet.
English: After two further weeks, continue with a dose of 40 mg every week.
Danish: Efter yderligere 2 uger fortsættes med 40 mg hver uge.
English: It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).
Danish: Ved langtidsbehandling anbefales årlig evaluering af benefit/risk (se pkt 5.1).
English: SOLYMBIC is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Danish: SOLYMBIC er indiceret til behandling af aktiv og progressiv psoriasisartrit hos voksne patienter, hvor responset på forudgående behandling med sygdomsmodificerende antireumatiske lægemidler har været utilstrækkelig.
English: The safety and efficacy of adalimumab in children aged 2-17 years have not yet been established.
Danish: Adalimumabs sikkerhed og virkning hos børn i alderen 2-17 år er ikke fastlagt.
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (PGA) score ranged from “moderate” (53% of subjects included) to “severe” (41%) to “very severe” (6%).
Danish: På tværs af alle behandlingsgrupper var den gennemsnitlige baseline-PASI-score 18,9, og baseline-PGA-score varierede fra “moderat” (53 % af de inkluderede patienter) til “alvorlig” (41 %) og “meget alvorlig” (6 %).
English: Table 9 Efficacy response in placebo-controlled axial SpA study
Danish: Respons på effektmål i placebo-kontrolleret Aksial SpA-Studie
English: Detailed instructions for use are provided in the package leaflet.
Danish: Indlægssedlen indeholder detaljerede instruktioner til anvendelsen.
English: Women of child bearing potential/Contraception in males and females
Danish: Kvinder i den fertile alder, prævention til mænd og kvinder
English: The recommended SOLYMBIC dose is 0.8 mg per kg body weight (up to a maximum of 40 mg per dose) administered subcutaneously weekly for the first two doses and every other week thereafter.
Danish: Den anbefalede SOLYMBIC-dosis er 0,8 mg pr. kg legemsvægt (op til maksimalt 40 mg pr dosis) som subkutan injektion administreret ugentlig de første to doser og derefter hver anden uge.
English: SOLYMBIC is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Danish: SOLYMBIC er indiceret til behandling af voksne med non-infektiøs intermediær, posterior og panuveitis, som har haft utilstrækkeligt respons på kortikosteroider, som har behov for kortikosteroidbesparende behandling, eller som ikke er egnet til behandling med kortikosteroider.
English: • Contact details of the prescriber
Danish: • Den ordinerende læges kontaktoplysninger.
English: SOLYMBIC is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Danish: SOLYMBIC er indiceret til behandling af voksne med alvorlig aktiv ankyloserende spondylitis, som ikke har responderet tilstrækkeligt på konventionel behandling.
English: Placebo Adalimumab 40 mg weekly
Danish: Placebo Adalimumab 40 mg ugentlig
English: Adalimumab 40 mg every other week was assessed in 185 patients in one randomised, 12 week double-blind, placebo-controlled study in patients with active non-radiographic axial spondyloarthritis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Danish: Adalimumab 40 mg hver anden uge er vurderet hos 185 patienter i et randomiseret, 12 ugers dobbeltblindet, placebokontrolleret studie hos patienter med aktiv non-radiografisk aksial spondyloartitis (gennemsnitlig baseline score for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,4 for patienter i behandling med adalimumab og 6,5 for patienter i placebo-armen), som havde haft utilstrækkeligt respons på eller var intolerante over for ≥ 1 NSAID eller havde en kontraindikation mod NSAID.
English: SOLYMBIC is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
Danish: SOLYMBIC er indiceret til behandling af svær kronisk plaque-psoriasis hos børn og unge fra 4 år, som har haft et utilstrækkeligt respons på, eller som ikke er egnede til topikal behandling eller lysbehandling.
English: Table 17 Induction of clinical remission and response (percent of patients)
Danish: Induktion af klinisk remission og respons (procent af patienterne)
English: (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 µg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 µg/mL with concomitant methotrexate.
Danish: (op til maksimalt 40 mg) subkutant hver anden uge til patienter med entesopatirelateret artrit i alderen 6 til 17 år var den gennemsnitlige dal-serumkoncentration af adalimumab ved steady state (målt i uge 24) 8,8 ± 6,6 µg/ml uden samtidig methotrexat og 11,8 ± 4,3 µg/ml med samtidig methotrexat.
English: Paediatric hidradenitis suppurativa
Danish: Pædiatrisk hidrosadenitis suppurativa
English: a a a p < 0.001, Adalimumab versus placebo
Danish: a a a p < 0,001, adalimumab vs. placebo
English: SOLYMBIC is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs.
Danish: SOLYMBIC er indiceret til behandling af voksne med alvorlig aksial spondyloartritis uden radiografiske tegn på AS, men med objektive tegn på inflammation ved forhøjet CRP og/eller MRI, som ikke har responderet tilstrækkeligt på eller er intolerante overfor NSAID.
English: The patient alert card shall contain the following key messages:
Danish: Patientkortet skal indeholde følgende hovedpunkter:
English: Packs sizes of one, two, four and six pre-filled syringes.
Danish: Pakningsstørrelser med én, to, fire og seks fyldte injektionssprøjter.
English: Leucocytosis, Thrombocytopaenia Uncommon Idiopathic thrombocytopaenic purpura Rare
Danish: Ikke almindelig Idiopatisk trombocytopenisk purpura Pancytopeni
English: If you are a breast-feeding mother, you should stop breast-feeding during SOLYMBIC treatment and for at least 5 months after the last SOLYMBIC treatment.
Danish: Hvis du ammer, bør du ophøre med at amme under SOLYMBIC-behandling og mindst 5 måneder efter den sidste behandling med SOLYMBIC.
English: Patients were randomised to receive either 24 mg/m body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Danish: Patienterne blev randomiseret til at få enten adalimumab 24 mg/m legemsoverfladeareal (BSA) op til maksimalt 40 mg eller placebo hver anden uge i 12 uger.
English: Part of the SOLYMBIC pre-filled syringe may be broken even if you cannot see the break.
Danish: Dele af injektionssprøjten kan være ødelagt, også selvom du ikke kan se noget brud.
English: Table 16 Proportion of patients a achieving HiSCR
Danish: Andel af patienter a, som opnår HiSCR
English: You might get infections more easily while you are receiving SOLYMBIC treatment.
Danish: - Infektioner kan opstå lettere under behandling med SOLYMBIC.
English: Stevens-Johnson syndrome1),
Danish: Erythema multiforme Stevens-Johnsons syndrom Angioødem
English: SOLYMBIC is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Danish: SOLYMBIC er indiceret til behandling af moderat til svær kronisk plaque-psoriasis hos voksne patienter, hvor systemisk behandling er relevant.
English: SOLYMBIC is administered by injection under the skin (subcutaneous injection).
Danish: SOLYMBIC indgives ved injektion under huden (subkutan injektion).
English: Table 18 Maintenance of clinical remission and response (percent of patients)
Danish: Vedligeholdelse af klinisk remission og respons (procent af patienterne)
English: Alternatively, if a patient has stopped SOLYMBIC and signs and symptoms of disease recur, SOLYMBIC may be re-administered.
Danish: Alternativt, kan SOLYMBIC gen-administreres, hvis patienten er stoppet behandling med SOLYMBIC, og tegn og symptomer på sygdommen kommer igen.
English: A single SOLYMBIC pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: En enkelt SOLYMBIC fyldt pen kan opbevares ved temperaturer op til 25 °C i en periode på højst 14 dage.
English: SOLYMBIC is used to treat moderate to severe plaque psoriasis in adults.
Danish: SOLYMBIC bruges til at behandle moderat til alvorlig plaque-psoriasis hos voksne.
English: c n = 207
Danish: MTXc n=207
English: SOLYMBIC is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Danish: SOLYMBIC bruges til at behandle ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis hos voksne.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from baseline) rates are presented in table 20.
Danish: Studiets primære effektmål var klinisk remission ved uge 26, defineret som PCDAI score ≤ 10. Rater for klinisk remission og klinisk respons (defineret som reduktion i PCDAI-score på mindst 15 point fra baseline) er vist i tabel 20.
English: P Value b
Danish: P-værdi b
English: SOLYMBIC is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Danish: SOLYMBIC er indiceret til behandling af moderat til svær aktiv colitis ulcerosa hos voksne, som ikke har responderet tilfredsstillende på konventionel behandling inklusive glukokortikoider og 6mercaptopurin (6-MP) eller azathioprin (AZA), eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge lægen eller apotekspersonalet til råds, før du tager SOLYMBIC.
English: Do not use the 40 mg pre-filled pen for the 20 mg dose in children or adolescent weighing less than 40 kg with Crohn's disease.
Danish: Brug ikke en 40 mg fyldt pen til dosis på 20 mg til børn eller unge med Crohns sygdom, der vejer under 40 kg. En 20 mg opløsning, injektionsvæske, i en fyldt sprøjte kan bruges til dosen på 20 mg.
English: If you do not respond well enough to these medicines, you will be given SOLYMBIC to treat your rheumatoid arthritis.
Danish: Hvis du ikke responderer tilstrækkeligt på disse lægemidler, kan du få SOLYMBIC til behandling af din reumatoide artrit.
English: Intestinal infections (including gastroenteritis viral), Skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotising fasciitis and herpes zoster), Ear infections,
Danish: Hud- og bløddelssinfektioner (inklusive paronychia, cellulitis, impetigo, nekrotiserende fasciitis og herpes zoster), Øreinfektioner,
English: Table 4 ACR responses in placebo-controlled trials (percent of patients)
Danish: ACR-respons i placebokontrollerede studie (procent af patienter)
English: SOLYMBIC is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Danish: SOLYMBIC er indiceret til behandling af aktiv entesopatirelateret artrit hos patienter fra 6 år, som har haft et utilstrækkeligt respons på, eller som er intolerante over for konventionel behandling (se pkt.
English: Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis
Danish: Psoriasisartrit og aksial spondyloartritis inklusive ankyloserende spondylitis
English: B. Inspect the SOLYMBIC pre-filled pen.
Danish: B. Kontrollér den fyldte pen.
English: Urinary tract infections (including pyelonephritis), Fungal infections,
Danish: Bivirkning vulvovaginal svampeinfektion), Urinvejsinfektioner (inklusive pylonephritis), Svampeinfektioner,
English: SOLYMBIC is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Danish: SOLYMBIC er indiceret til behandling af moderat til svær aktiv Crohns sygdom hos pædiatriske patienter (fra 6 år), som har haft utilstrækkeligt respons på konventionel behandling inklusive primær ernæringsbehandling, kortikosteroidbehandling og immunmodulerende behandling, eller som er intolerante over for eller har kontraindikationer mod sådanne behandlinger.
English: Impaired renal and/or hepatic function
Danish: Nedsat nyre- og/eller leverfunktion
English: Very common Rash (including exfoliative rash) Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)
Danish: Forværring eller nye udbrud af psoriasis (herunder palmoplantar pustuløs psoriasis) Urticaria,
English: EU/1/16/1163/002 1 pack EU/1/16/1163/003 2 pack EU/1/16/1163/004 4 pack EU/1/16/1163/005 6 pack
Danish: EU/1/16/1163/002 pakning med 1 EU/1/16/1163/003 pakning med 2 EU/1/16/1163/004 pakning med 4 EU/1/16/1163/005 pakning med 6
English: SOLYMBIC is used to treat hidradenitis suppurativa in adults.
Danish: SOLYMBIC bruges til at behandle hidrosadenitis suppurativa hos voksne.
English: SOLYMBIC 20 mg solution for injection in pre-filled syringe EU/1/16/1163/001 - 1 pack
Danish: SOLYMBIC 20 mg injektionsvæske, opløsning i fyldt injektionssprøjte EU/1/16/1163/001 - pakning med 1
English: EU/1/16/1163/006 1 pack EU/1/16/1163/007 2 pack EU/1/16/1163/008 4 pack EU/1/16/1163/009 6 pack
Danish: EU/1/16/1163/006 pakning med 1 EU/1/16/1163/007 pakning med 2 EU/1/16/1163/008 pakning med 4 EU/1/16/1163/009 pakning med 6
English: The usual dose regimen for Crohn's disease is 80 mg initially followed by 40 mg every other week two weeks later.
Danish: Startdosis for Crohns sygdom er sædvanligvis 80 mg efterfulgt af 40 mg hver anden uge 2 uger senere.
English: Oral infections (including herpes simplex, oral herpes and tooth infections),
Danish: Orale infektioner (inklusive herpes simplex, oral herpes og tandinfektioner), Infektioner i reproduktionsvejene (inklusive
English: SOLYMBIC reduces the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and improves physical function.
Danish: SOLYMBIC reducerer den udviklingshastighed, hvormed de perifere led destrueres, bedømt ved måling med røntgen hos patienter med polyartikulære, symmetriske undertyper af sygdommen (se pkt.
English: The recommended dose of SOLYMBIC for patients with enthesitis-related arthritis 6 years of age and older is 24 mg/m² body surface area up to a maximum single dose of 40 mg adalimumab administered every other week via subcutaneous injection.
Danish: Den anbefalede SOLYMBIC-dosis til patienter på 6 år og derover med entesopati-relateret artrit er 24 mg/m legemsoverfladeareal op til en enkeltdosis på maksimalt 40 mg adalimumab, administreret hver anden uge som subkutan injektion.
English: SOLYMBIC therapy should not be continued in patients failing to respond within this time period.
Danish: Fortsat behandling med SOLYMBIC anbefales ikke til patienter, der ikke responderer inden for denne tidsperiode.
English: ● Do not use a SOLYMBIC pre-filled syringe if it has been dropped on a hard surface.
Danish: ● Brug ikke en fyldt injektionssprøjte, hvis den har været tabt på en hård flade.
English: The safety and efficacy of adalimumab in children aged 12-17 years have not yet been established for hidradenitis suppurativa.
Danish: Adalimumabs sikkerhed og virkning ved hidrosadenitis suppurativa hos børn i alderen 12-17 år er endnu ikke klarlagt.
English: CARTON PRE-FILLED PEN
Danish: KARTON MED FYLDT PEN
English: The recommended SOLYMBIC induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (dose can be administered as four injections in one day or as two injections per day for two consecutive days) and 80 mg at week 2.
Danish: Det anbefalede SOLYMBIC dosis-induktionsregime til voksne patienter med moderat til svær colitis ulcerosa er 160 mg i uge 0 (dosis kan administreres som fire injektioner på en dag eller som to injektioner pr. dag i to på hinanden følgende dage) og 80 mg i uge 2.
English: SOLYMBIC 40 mg solution for injection in pre-filled syringe EU/1/16/1163/002 - 1 pack
Danish: SOLYMBIC 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte EU/1/16/1163/002 - pakning med 1
English: In rheumatoid arthritis, methotrexate is continued while using SOLYMBIC.
Danish: Hvis du har reumatoid artrit, kan du fortsætte med methotrexat under behandling med SOLYMBIC.
English: It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating SOLYMBIC therapy.
Danish: Før behandling med SOLYMBIC påbegyndes, anbefales det, hvis det er muligt, at bringe pædiatriske patienter ajour med alle immuniseringer i overenstemmelse med gældende immuniseringsvejledninger.
English: SOLYMBIC is used to treat rheumatoid arthritis in adults.
Danish: SOLYMBIC bruges til at behandle reumatoid artrit hos voksne.
English: CD study I and CD study II induction of remission and response rates are presented in table 17
Danish: Tabel 17 viser rater for induktion af remission og respons i CD-studie I og CD-studie II.
English: A single SOLYMBIC pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: En enkelt SOLYMBIC fyldt injektionssprøjte kan opbevares ved temperaturer op til 25 °C i en periode på højst 14 dage.
English: MTX = methotrexate b P = 0.027, adalimumab 0.8 mg/kg versus MTX
Danish: PGA: clear/minimal a MTX = methotrexat b P = 0,027, adalimumab 0,8 mg/kg versus MTX c P = 0,083, adalimumab 0,8 mg/kg versus MTX
English: SOLYMBIC is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.
Danish: SOLYMBIC er indiceret til behandling af aktiv moderat til svær hidrosadenitis suppurativa (svedkirtelbetændelse) hos voksne patienter, hvor responset på konventionel systemisk HS-behandling har været utilstrækkelig.
English: PGA: Clear/minimal b a Percent of patients achieving PASI75 response was calculated as centre-adjusted rate b p < 0.001, adalimumab versus placebo
Danish: Procent af patienterne, som opnåede PASI 75-respons beregnet med justering for center variation b p<0,001, adalimumab versus Placebo
English: Before you use a SOLYMBIC pre-filled pen, read this important information:
Danish: Læs disse vigtige oplysninger, inden du bruger en SOLYMBIC fyldt pen:
English: SOLYMBIC is intended for treatment of rheumatoid arthritis, enthesitis-related arthritis in children 6 to 17 years, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, paediatric psoriasis (patients weighing either 23 to 28 kg or 47 kg and greater), Crohn's disease in adults and children, ulcerative colitis and non-infectious uveitis affecting the back of the eye.
Danish: SOLYMBIC er beregnet til behandling af reumatoid artrit, entesopati-relateret artrit hos børn i alderen 6-17 år, ankyloserende spondylitis, aksial spondyloartritis uden radiografiske tegn på AS, psoriasisartrit, psoriasis, hidrosadenitis suppurativa, pædiatrisk psoriasis (patienter, der vejer enten 23-28 kg eller 47 kg og derover), Crohns sygdom hos voksne og børn, colitis ulcerosa og ikke-infektiøs uveitis, som påvirker bageste del af øjet.
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias
Danish: Alle patienter bør rådes til at søge læge omgående, hvis de under behandling med SOLYMBIC, udvikler tegn og symptomer på bloddyskrasi (f.eks. vedvarende feber, blå mærker, blødning, bleghed).
English: If you do not respond well enough to these medicines, you will be given SOLYMBIC to reduce the signs and symptoms of your Crohn's disease.
Danish: Hvis du ikke har tilstrækkelig effekt af den medicin, vil du blive tilbudt SOLYMBIC til reduktion af sygdomstegn og symptomer på din Crohns sygdom.
English: Glacial acetic acid, sucrose, polysorbate 80, sodium hydroxide and water for injection.
Danish: Iseddike, sucrose, polysorbat 80, natriumhydroxid og vand til injektionvæsker.
English: N = 248 N=248
Danish: N = 248
English: 6 pre-filled syringes.
Danish: 6 fyldte injektionssprøjter.