FrancophonIA/ELRC3.0 huggingface dataset:
English: Administration of live vaccines to infants exposed to SOLYMBIC in utero is not recommended for 5 months following the mother's last SOLYMBIC injection during pregnancy.
Danish: Administration af levende vacciner til spædbørn, som har været eksponeret for SOLYMBIC in utero, anbefales ikke i 5 måneder efter moderens sidste SOLYMBIC-injektion under graviditeten.
English: At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Danish: I uge 52 opnåede 42,9 % af patienterne, som fik adalimumab/methotrexat-kombinationsterapi, klinisk remission (DAS28 < 2,6) sammenlignet med 20,6 % af patienterne, som fik methotrexat-monoterapi og 23,4% af patienterne, som fik adalimumab-monoterapi.
English: a HR of adalimumab versus placebo from proportional hazards regression with treatment as factor.
Danish: HR af adalimumab vs placebo ved regressionsanalyse med behandling som baggrundsvariabel.
English: A. Remove one SOLYMBIC pre-filled pen from the package.
Danish: A. Tag én SOLYMBIC fyldt pen ud af pakningen.
English: People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a type of cancer that affects the lymph system), and leukaemia (a type of cancer that affects the blood and bone marrow).
Danish: Patienter med mere alvorlig reumatoid artrit, som har haft sygdommen i lang tid, kan have øget risiko i forhold til gennemsnittet for at få lymfomer (en type kræft, som påvirker lymfesystemt) og leukæmi (en type kræft) som påvirker blod og knoglemarv).
English: Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with SOLYMBIC.
Danish: Der kan fortsættes med glukokortikoider, salicylater, non-steroide antiinflammatoriske eller analgetiske lægemidler under behandling med SOLYMBIC.
English: Table 7 Radiographic mean changes at week 52 in RA study V
Danish: Gennemsnitlige radiografiske ændringer i uge 52 i RA-studie V
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See table 23).
Danish: Resultaterne i begge studier viste en statistisk signifikant reduktion i risikoen for behandlingssvigt hos patienter behandlet med adalimumab versus patienter, som fik placebo (se tabel 23).
English: Thirty-three (18%) of patients were treated concomitantly with disease-modifying anti-rheumatic drugs, and 146 (79%) patients with NSAIDs at baseline.
Danish: Treogtredive (18%) patienter fik samtidig behandling med sygdomsmodificerende anti-reumatiske lægemidler, og 146 (79%) patienter fik NSAID ved baseline.
English: Some of those patients were also treated with azathioprine or 6-mercaptopurine.
Danish: Nogle af disse patienter blev også behandlet med azathioprin eller 6-mercaptopurin.
English: Women of childbearing potential are strongly recommended to use adequate contraception to prevent pregnancy and continue its use for at least five months after the last SOLYMBIC treatment.
Danish: Kvinder i den fertile alder anbefales kraftigt at anvende passende prævention for at forebygge graviditet og fortsætte med at anvende prævention i mindst fem måneder efter den sidste SOLYMBIC-behandling.
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84%) patients in the adalimumab group who remained in the study.
Danish: Forbedring i antallet af led med aktiv artrit blev opretholdt i den åbne del af studiet i 156 uger for 26 ud af de 31 (84 %) patienter i adalimumab-gruppen.
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of SOLYMBIC, and in accordance with local recommendations.
Danish: Hvis der diagnosticeres ‘latent' tuberkulose, skal profylaktisk behandling mod tuberkulose påbegyndes i overensstemmelse med lokale anbefalinger, inden behandling med SOLYMBIC startes.
English: SOLYMBIC can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: SOLYMBIC kan anvendes sammen med methotrexat eller visse sygdomsmodificerende antireumatiske lægemidler (sulfasalazin, hydroxychloroquin, leflunomid og guldpræparater til injektion), steroider eller smertemedicin, herunder non-steroide anti-inflammatoriske lægemidler (NSAIDs).
English: In non-infectious uveitis, corticosteroids or other medicines that influence the immune system may be continued while using SOLYMBIC.
Danish: Ved ikke-infektiøs uveitis kan du fortsætte med at bruge kortikosteroider eller andre lægemidler, som påvirker immunsystemet, mens du tager SOLYMBIC.
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with adalimumab in one or more subsets of the paediatric population in ulcerative colitis and non-infectious uveitis, see section 4.2 for information on paediatric use.
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med adalimumab i en eller flere undergrupper af den pædiatriske population med colitis ulcerosa og non-infektiøs uveitis (se pkt.
English: Discontinuation of Immunomodulators
Danish: Seponering af immunomodulerende-midler
English: The recommended dose of SOLYMBIC for patients with enthesitis-related arthritis, aged 6 to 17 years depends on the height and weight of the child.
Danish: Den anbefalede SOLYMBIC-dosis til børn i alderen 6-17 år med entesopati-relateret artrit afhænger af barnets højde og vægt.
English: Table 15 Efficacy results at 12 weeks, HS studies I and II
Danish: Effektresultater ved uge 12, HS-Studie I og II
English: What you need to know before you use SOLYMBIC
Danish: Det skal du vide, før du begynder at tage SOLYMBIC
English: It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with SOLYMBIC.
Danish: Det anbefales, at patienten vasker sine HS-læsioner dagligt med topikal antiseptisk vask under SOLYMBICbehandlingen.
English: Do not use the 40 mg pre-filled pen if doses other than 40 mg are recommended.
Danish: - Brug ikke fyldte pennen med 40 mg, hvis en anden dosis end 40 mg er anbefalet.
English: If you stop using SOLYMBIC
Danish: Hvis du holder op med at tage SOLYMBIC
English: 95% confidence intervals for the differences in change scores between methotrexate and adalimumab c Based on rank analysis d
Danish: d score a methotrexat b 95 % Konfidensintervaller for forskellen i ændring af score mellem methotrexat og adalimumab c Baseret på ranganalyse d Ledspalteforsnævring
English: Adalimumab/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see table 6).
Danish: Der blev observeret en significant mindre radiografisk progression hos adalimumab-/ methotrexat-patienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se Tabel 6).
English: If you forget to use SOLYMBIC
Danish: Hvis du har glemt at tage SOLYMBIC
English: Table 11 Ps study I (REVEAL) - efficacy results at 16 weeks
Danish: Ps-studie I (REVEAL) - effektresultater ved uge 16
English: PGA: Clear/minimal a, b a p < 0.001 adalimumab versus placebo b p < 0.001 adalimumab versus methotrexate c p < 0.01 adalimumab versus placebo d p < 0.05 adalimumab versus methotrexate
Danish: PGA: Clear/minimal a, b a p<0,001 adalimumab versus placebo b p<0,001 adalimumab versus methotrexat c p<0,01 adalimumab versus placebo d p<0,05 adalimumab versus methotrexat
English: Vaccinations: if possible children should be up to date with all vaccinations before using SOLYMBIC.
Danish: - Vaccinationer: hvis det er muligt, skal dit barn føres ajour med alle vaccinationer, før behandling med SOLYMBIC startes.
English: If you are about to undergo surgery or dental procedures please inform your doctor that you are taking SOLYMBIC.
Danish: - Hvis du skal opereres eller have tandbehandling, bør du informere din læge om, at du tager SOLYMBIC.
English: The MAH shall ensure that in each Member State where Solymbic is marketed, all healthcare professionals who are expected to prescribe Solymbic have are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at nedenstående undervisningsmateriale stilles til rådighed for/udleveres til alle sundhedsmedarbejdere, der forventes at ordinere Solymbic, i hvert medlemsland, hvor Solymbic markedsføres:
English: Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Danish: Bath Ankylosing Spondylitis Disease Activity Index
English: Week 12 results showed statistically significant improvement of the signs and symptoms of active non-radiographic axial spondyloarthritis in patients treated with adalimumab compared to placebo (table 9).
Danish: Resultaterne i uge 12 viste statististisk signifikante forbedringer på tegn og symptomer på aktiv non-radiografisk aksial spondyloartritis hos patienter i behandling med adalimumab sammenlignet med placebo (Tabel 9).
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with SOLYMBIC.
Danish: I overensstemmelse med klinisk praksis kan samtidig steroidbehandling nedtrappes med start to uger efter initiering af SOLYMBIC-behandling.
English: Thus additional caution should be exercised in considering SOLYMBIC treatment of these patients (see section 4.8).
Danish: Der bør derfor udvises ekstra forsigtighed, hvis behandling med SOLYMBIC overvejes til sådanne patienter (se pkt.
English: SOLYMBIC reduces the rate of progression of joint damage as measured by x-ray and improves physical function, when given in combination with methotrexate.
Danish: SOLYMBIC hæmmer udviklingen af leddestruktion bedømt ved måling med røntgen og forbedrer den fysiske funktion, når det gives i kombination med methotrexat.
English: SOLYMBIC is administered by subcutaneous injection.
Danish: SOLYMBIC administeres ved subkutan injektion.
English: Tell your doctor if you are taking azathioprine or 6-mercaptopurine with SOLYMBIC.
Danish: Fortæl din læge, hvis du får azathioprin eller 6-mercaptopurin sammen med SOLYMBIC.
English: Table 2 SOLYMBIC dose in milligrams (mg) by weight for patients with paediatric psoriasis
Danish: SOLYMBIC-dosis i milligram (mg) efter vægt for patienter med pædiatrisk psoriasis
English: Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30% plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p < 0.05 for adalimumab versus placebo pairwise comparison of proportions ** p < 0.001 for adalimumab versus placebo pairwise comparison of proportions a
Danish: Klinisk respons er fald fra baseline i Mayo score på ≥ 3 point og ≥ 30 % samt et fald i rektal blødning-subscore [RBS] på ≥ 1 eller en absolut RBS på 0 eller 1; *p < 0,05 for adalimumab versus placebo ved parvis sammeligning af andelene **p < 0,001 for adalimumab versus placebo ved parvis sammeligning af andelene a Af de patienter, der fik steroid ved baseline
English: Demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)
Danish: Demyeliniserende sygdomme (f.eks. opticus neuritis, Guillain-Barré syndrom)
English: All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with SOLYMBIC.
Danish: Alle patienter og specielt patienter, som tidligere har fået omfattende immunsuppresiv behandling, og psoriasis-patienter, der tidligere har været behandlet med PUVA, skal undersøges for ikke-melanom hudkræft inden og under behandling med SOLYMBIC.
English: Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.
Danish: Hvis du glemmer at give dig selv en injektion, bør du gøre det, så snart du kommer i tanke om det. Fortsæt dernæst med at injicere næste dosis som planlagt på den oprindelig fastlagte dag, som om du ikke havde glemt en dosis.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with SOLYMBIC cannot be excluded (see section 4.8).
Danish: En risiko for udvikling af hepatosplenisk Tcelle lymfom hos patienter, der bliver behandlet med SOLYMBIC, kan ikke udelukkes (se pkt.
English: Steroid-free remission for ≥ 90 days
Danish: Klinisk remission Slimhindeheling Steroid-fri remission i ≥ 90 dage a
English: ● Do not use a SOLYMBIC pre-filled pen if it has been dropped on a hard surface.
Danish: ● Brug ikke en fyldt pen, hvis den har været tabt på en hård flade.
English: SOLYMBIC can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Danish: SOLYMBIC kan også anvendes til behandling af alvorlig aktiv og progressiv reumatoid artrit, der ikke tidligere er behandlet med methotrexat.
English: SOLYMBIC is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Danish: SOLYMBIC bruges til at behandle entesopati-relateret artrit hos børn og unge i alderen 6-17 år.
English: For adalimumab, limited clinical data on exposed pregnancies are available.
Danish: Der foreligger begrænsede kliniske data om eksponering for adalimumab under graviditet.
English: Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n = 91 placebo and n = 87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n = 73 placebo and n = 70 adalimumab h
Danish: SPARCC MRI rygsøjlen d,j a Assessments of Spondyloarthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d gennemsnitlig ændring fra baseline e n = 91 placebo og n = 87 adalimumab f høj følsomhed C-reaktivt protein (mg/l) g n = 73 placebo and n = 70 adalimumab h Spondyloarthritis Research Consortium of Canada i n = 84 placebo og adalimumab j n = 82 placebo og n = 85 adalimumab
English: This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e. essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. 0,8 ml dosis.
English: Tell your doctor immediately if you notice any of the following:
Danish: Kontakt omgående lægen, hvis du får følgende symptomer:
English: Uncommon Pulmonary embolism Interstitial lung disease, Chronic obstructive pulmonary disease, Pneumonitis,
Danish: Interstitiel lungesygdom, Kronisk obstruktiv lungesygdom, Pneumonitis,
English: a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Danish: a p-værdi for den parvise sammenligning af methotrexat-monoterapi og adalimumab/methotrexatkombinationeterapi ved anvendelse af Mann-Whitney U test b p-værdi for den parvise sammenligning af adalimumab-monoterapi og adalimumab/methotrexatkombinationsterapi ved anvendelse af Mann-Whitney U test c p-værdi for den parvise sammenligning af adalimumab-monoterapi og methotrexat-monoterapi ved anvendelse af Mann-Whitney U test
English: Table 5 ACR responses in RA study V (percent of patients)
Danish: ACR-respons i RA-studie V (procentdel af patienter)
English: SOLYMBIC slows down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Danish: SOLYMBIC nedsætter hastigheden for ødelæggelse af brusk og knogler i leddene forårsaget af sygdommen og at forbedre den fysiske funktion.
English: A 40 mg pen, and a 20 mg and 40 mg pre-filled syringes are available for patients to administer a full 20 mg or 40 mg dose.
Danish: En 40 mg pen og en 20 mg eller 40 mg fyldt injektionssprøjte er tilgængelig til administration af en fuld dosis på 20 mg eller 40 mg.
English: Table 12 Ps study II (CHAMPION) efficacy results at 16 weeks
Danish: Ps-studie II (CHAMPION) - effektresultater ved uge 16
English: All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p < 0.001
Danish: Alle p-værdier er parvise sammenligninger af andelene for adalimumab vs. placebo * p < 0,001
English: Each pack contains 1, 2, 4, or 6 single use SureClick pre-filled pens.
Danish: Hver pakning indeholder 1, 2, 4 eller 6 SureClick fyldte penne.
English: Antibiotics may be continued during treatment with SOLYMBIC if necessary.
Danish: Hvis det er nødvendigt, kan behandling med antibiotika fortsættes under SOLYMBIC-behandlingen.
English: In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see table 5).
Danish: I RA-studie V med patienter med reumatoid artrit på et tidligt stadium, som var methotrexat-naive, førte kombinationsbehandlingen med adalimumab og methotrexat til hurtigere og signifikant større ACR-respons end methotrexat-monoterapi og adalimumab-monoterapi i uge 52, og effekten blev opretholdt i 104 uger (se tabel 5).
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Danish: Brug ikke SOLYMBIC efter den udløbsdato, der står på etiketten og pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Talk to your doctor or pharmacist before using SOLYMBIC:
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager SOLYMBIC:
English: SOLYMBIC single use SureClick pre-filled pen For subcutaneous use
Danish: SOLYMBIC fyldt SureClick pen til engangsbrug Til subkutan anvendelse
English: SOLYMBIC dose in milligrams (mg) by height and weight of patients for enthesitis-related arthritis
Danish: SOLYMBIC-dosis i milligram (mg) efter patientens højde og vægt for entesopatirelateret artrit
English: Prescribers should exercise caution in considering the use of SOLYMBIC in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of SOLYMBIC should be considered if any of these disorders develop.
Danish: Lægen bør udvise forsigtighed, når behandling med SOLYMBIC overvejes til patienter med allerede eksisterende eller nyligt opståede demyeliniserende sygdomme i centralnervesystemet eller det perifere nervesystem, og seponering af SOLYMBIC skal overvejes, hvis nogle af disse sygdomme forværres.
English: In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see table 16).
Danish: Hos patienter med minimum et delvist respons på adalimumab 40 mg ugentlig ved uge 12 var HiSCRraten ved uge 36 højere hos patienter, der fortsatte ugentlig adalimumab, end hos de patienter, hvor doseringshyppigheden blev reduceret til hver anden ugen eller behandlingen afbrudt (Se tabel 16).
English: Time to treatment failure at or after week 6 in study UV I Primary analysis (ITT)
Danish: Tid til behandlingssvigt i eller efter uge 6 i studie UV I Primær analyse (ITT)
English: The observed rate of nonmelanoma skin cancers is approximately 9.6 per 1,000 patient-years, and the observed rate of lymphomas is approximately 1.3 per 1,000 patient-years.
Danish: Den fundne hyppighed af ikke melanom hudkræft er cirka 9,6 pr. 1.000 patientår og den fundne hyppighed af lymfomer er cirka 1,3 pr. 1.000 patientår.
English: Paediatric Crohn's disease patients ≥ 40 kg:
Danish: Crohns sygdom hos børn ≥ 40 kg:
English: Part of the SOLYMBIC pre-filled pen may be broken even if you cannot see the break.
Danish: Dele af pennen kan være ødelagt, også selvom du ikke kan se noget brud.
English: Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g. persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with SOLYMBIC.
Danish: Patienter bør instrueres i at søge læge, hvis der opstår sygdomstegn/symptomer, der tyder på tuberkulose (f.eks. vedvarende hoste, tæring/vægttab, lav feber, apati) under eller efter behandling med SOLYMBIC.
English: Use a new SOLYMBIC pre-filled pen.
Danish: Brug en ny SOLYMBIC fyldt pen.
English: SOLYMBIC is injected under the skin (subcutaneous use).
Danish: SOLYMBIC injiceres under huden (subkutan anvendelse).
English: You are advised to avoid becoming pregnant and must use adequate contraception while using SOLYMBIC and for at least 5 months after the last SOLYMBIC treatment.
Danish: Du rådes til at undgå at blive gravid og til at bruge passende prævention under behandling med SOLYMBIC og mindst 5 måneder efter den sidste behandling med SOLYMBIC.
English: Patients induced with 160/80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18% versus 9% respectively, p = 0.031) and study UC-II (17% versus 9% respectively, p = 0.019).
Danish: I forhold til placebo opnåede en statistisk signifikant større procentdel af de patienter, der blev induceret med 160/80 mg adalimumab, klinisk remission i uge 8 (studie UC-I: henholdsvis 18 % og 9 %, p=0,031; studie UC-II: henholdsvis 17 % og 9 %, p=0,019).
English: Methotrexate should be continued during treatment with SOLYMBIC.
Danish: Der fortsættes med methotrexat under behandling med SOLYMBIC.
English: Patients above 4 years of age but with a weight less than 23 kg or between 29 and 46 kg are not possible to dose with this product.
Danish: Det er ikke muligt at dosere dette produkt til patienter over 4 år, der vejer under 23 kg eller mellem 29 og 46 kg.
English: Table 8 Efficacy responses in placebo-controlled AS study - study I reduction of signs and symptoms
Danish: Effekt respons i placebo-kontrolleret AS-studie I Reduktion af tegn og symptomer
English: Paediatric Crohn's disease patients < 40 kg:
Danish: Crohns sygdom hos børn < 40 kg:
English: LABEL PRE-FILLED PEN
Danish: ETIKET TIL FYLDT PEN
English: On rare occasions, a specific and severe type of lymphoma has been observed in some patients taking adalimumab.
Danish: I sjældne tilfælde er der set en alvorlig undertype af lymfom hos nogle patienter, som tog adalimumab.
English: Packs sizes of one, two, four and six pre-filled pens.
Danish: Pakningsstørrelser med én, to, fire og seks fyldte penne.
English: Table 21 Paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission
Danish: Pædiatrisk CD-studie Seponering af kortikosteroider eller immunmodulerende lægemidler og remisssion af fistler
English: bruise or bleed very easily or look very pale, call your doctor right away.
Danish: Hvis du får feber, som ikke vil forsvinde, blå mærker eller bløder meget let eller er meget bleg, skal du omgående henvende dig til din læge.
English: Sustained response Sustained remission Sustained mucosal healing
Danish: Vedligeholdt respons Vedligeholdt remission Vedligeholdt slimhindeheling
English: Time to treatment failure at or after week 2 in study UV II Primary analysis (ITT)
Danish: Tid til behandlingssvigt i eller efter uge 2 i studie UV II Primær analyse (ITT)