FrancophonIA/ELRC3.0 huggingface dataset:
English: • Only use each pre-filled pen for one injection.
Danish: • Brug kun hver fyldt pen til én injektion.
English: The Humira pre-filled syringe is available in a pack containing 1 pre-filled syringe for patient use with 1 alcohol pad.
Danish: Humira fyldt injektionssprøjte findes i en pakning indeholdende 1fyldt injektionssprøjte til patientbrug med 1 alkoholserviet.
English: Discontinuation of Immunomodulators
Danish: Seponering af immunomodulerendemidler2
English: If you stop using Humira
Danish: Hvis du holder op med at bruge Humira
English: Do not try to touch the needle.
Danish: Forsøg ikke at røre kanylen.
English: Luxembourg/Luxemburg AbbVie SA
Danish: Luxembourg/Luxemburg
English: In patients with moderately to severely active paediatric Crohn's disease, the rate of anti-adalimumab antibody development in patients receiving adalimumab was 3.3%.
Danish: Blandt patienter med moderat til svær aktiv pædiatrisk Crohns sygdom udviklede 3,3% af de patienter, som fik adalimumab, anti-adalimumab-antistoffer.
English: Thus additional caution should be exercised in considering Humira treatment of these patients (see section 4.8).
Danish: Der bør derfor udvises ekstra forsigtighed, hvis behandling med Humira overvejes til sådanne patienter (se pkt.
English: Humira has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Danish: Humira er ikke undersøgt hos patienter under 6 år med entesopatirelateret artrit.
English: Some of those patients were also treated with azathioprine or 6mercaptopurine.
Danish: Nogle af disse patienter blev også behandlet med azathioprin eller 6-mercaptopurin.
English: PsA Study II
Danish: PsA-studie II
English: • The syringe, needle, vial and vial adapter MUST NEVER be reused.
Danish: • Sprøjten, kanylen, hætteglas og hætteglasadapteren må ALDRIG genbruges.
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 Humira.
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 Humira.
English: Psoriasis Study III (REACH) compared the efficacy and safety of Humira versus placebo in 72 patients with moderate to severe chronic plaque psoriasis and hand and/or foot psoriasis.
Danish: Psoriasis-studie III (REACH) sammenlignede Humiras virkning og sikkerhed versus placebo hos 72 patienter med moderat til svær kronisk plaque-psoriasis og psoriasis på hænder og/eller fødder.
English: Your doctor will decide if your child should receive Humira.
Danish: Lægen vil tage stilling til, om dit barn skal have Humira.
English: • Hold the syringe in one hand and with the other hand slide the outer protective shield over the exposed needle until it locks in place
Danish: • Hold sprøjten i den ene hånd og lad det yderste beskyttende lag af glide ind over kanylen med den anden hånd, indtil det er på plads
English: If the white plunger rod is pulled completely out of the syringe, discard the syringe and contact your Humira provider for a replacement.
Danish: NB: Hvis du trækker stemplet helt ud af sprøjten skal du kassere sprøjten og kontakte det sted hvor du fik Humira for at få en erstatningssprøjte.
English: The active ingredient in Humira, adalimumab, is a human monoclonal antibody.
Danish: Det aktive stof i Humira, adalimumab, er et humant monoklonalt antistof.
English: • Throw away all other used items into your regular household waste.
Danish: • Det øvrige affald kan smides ud med husholdningsaffaldet.
English: If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for your child.
Danish: Hvis dit barn har KOL, eller ryger meget, bør du diskutere med lægen, om behandling med en TNF-hæmmer er passende for dit barn.
English: Humira 40 mg every other week was assessed in 393 patients in two randomised, 24 week double − blind, placebo − controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Danish: Humira 40 mg hver anden uge blev undersøgt i to randomiserede, 24 ugers dobbelt-blinde placebokontrollerede studier med 393 patienter med aktiv ankyloserende spondylitis (gennemsnits score ved baseline for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,3 i alle grupper), som ikke havde responderet tilstrækkeligt på konventionel behandling.
English: • musculoskeletal pain.
Danish: • muskuloskeletale smerter.
English: Total Sharp Score Erosion score JSN
Danish: Total Sharp Score
English: • neuropathy (disorder of the nerves)
Danish: • neuropati (nervelidelse)
English: Pull the Plum-coloured Cap 2 straight off.
Danish: Træk den blommefarvede sikkerhedshætte 2 lige af.
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: Of the 364 remaining patients, 269 evaluable patients (74%) reached 78 weeks of open-label adalimumab treatment.
Danish: Ud af de 364 resterende patienter opnåede 269 egnede patienter (74%) 78 uger med åben adalimumab-behandling.
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leukopenia) have been reported with Humira.
Danish: Hæmatologiske bivirkninger herunder klinisk signifikant cytopeni (f.eks. trombocytopeni, leukopeni) er rapporteret efter behandling med Humira.
English: • If your child is pregnant, thinks she may be pregnant or is planning to have a baby, ask her doctor for advice about taking this medicine.
Danish: • Hvis dit barn er gravid, har mistanke, om at hun er gravid, eller planlægger at blive gravid, skal hun spørge sin læge til råds, før hun tager dette lægemiddel.
English: There is limited safety experience of surgical procedures in patients treated with Humira.
Danish: Der er begrænset erfaring med sikkerhed efter kirurgiske indgreb hos patienter i behandling med Humira.
English: • Do not use the pre-filled pen if it has been dropped or crushed
Danish: • Brug ikke den fyldte pen, hvis den har været tabt eller knust
English: The white needle sleeve will now be exposed.
Danish: Det hvide beskyttelseshylster til kanylen vil nu kunne ses.
English: Psoriasis Study IV compared efficacy and safety of Humira versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Danish: Psoriasis-studie IV sammenlignede Humiras virkning og sikkerhed overfor placebo i 217 voksne patienter med moderat til svær neglepsoriasis.
English: Hold the grey body of the pre-filled pen with one hand.
Danish: Hold den fyldte pens grå hoveddel med den ene hånd.
English: • With the other hand, hold syringe at 45-degree angle to skin, with the grooved side up.
Danish: • Hold sprøjten med den anden hånd i en vinkel på 45° mod huden med den rillede side opad.
English: In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg Humira at Week 0 and 80 mg at Week 2 or placebo at Weeks 0 and 2.
Danish: I CD-studie II blev 325 patienter, der ikke længere responderede eller var intolerante over for infliximab, randomiseret til at få enten 160 mg Humira i uge 0 og 80 mg i uge 2 eller placebo i uge 0 og 2.
English: Humira 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: Humira 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: • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
Danish: • Stevens-Johnsons syndrom (tidlige symptomer inkluderer utilpashed, feber, hovedpine og udslæt)
English: Firmly push the pre-filled pen down against the injection site before starting the injection.
Danish: Tryk den fyldte pen fast ned mod injektionsstedet, inden injektionen startes.
English: The following instructions explain how to inject Humira.
Danish: Følgende er en vejledning i, hvordan man injicerer Humira.
English: • While holding the vial, push the white plunger rod all the way down.
Danish: • Mens du holder fast i hætteglasset, skubbes stemplet hele vejen ned.
English: • reduction in blood platelets which increases risk of bleeding or bruising
Danish: • nedsat antal blodplader med forøget risiko for blødning eller blå mærker
English: Phase OL-LI 16 weeks Ped ACR 30 response (n/N)
Danish: Åben indkøringsfase uge Pædiatrisk ACR 30respons (n/N)
English: • As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check your child for signs and symptoms of tuberculosis before starting Humira.
Danish: • Eftersom der har været rapporteret tilfælde af tuberkulose hos patienter i behandling med Humira, vil lægen undersøge dit barn for tegn og symptomer på tuberkulose, før behandling med Humira påbegyndes.
English: Each pack contains 1, 2, 4 or 6 pre-filled syringes for patient use with 1, 2, 4 or 6 alcohol pads, respectively.
Danish: Hver pakning indeholder 1, 2, 4 eller 6 fyldte injektionssprøjter til patientbrug med henholdsvis 1, 2, 4 eller 6 alkoholservietter.
English: Injecting Humira
Danish: Injektion af Humira
English: • severe rash, hives or other signs of allergic reaction
Danish: • alvorligt udslæt, nældefeber eller andre tegn på en allergisk reaktion
English: Do not press the plum activator button until you are ready to inject.
Danish: Tryk ikke på den blommefarvede aktiveringsknap, før du er klar til at injicere.
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Humira cannot be excluded (see section 4.8).
Danish: En risiko for udvikling af hepatosplenisk T-celle lymfom hos patienter, der bliver behandlet med Humira kan ikke udelukkes (se pkt.
English: In addition cases of non-melanoma skin cancer have been observed in patients taking Humira.
Danish: Derudover er der set tilfælde af ikke-melanom hudkræft hos patienter, der tager Humira.
English: Paraesthesias (including hypoesthesia), migraine, nerve root compression
Danish: Paræstesi (inklusive hypæstesi), migræne, nerverodskompression
English: RA studies VI and VII each evaluated 60 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Danish: RA-studie VI og VII evaluerede hver 60 patienter ≥ 18 år med moderat til alvorlig aktiv reumatoid artrit.
English: • Do not give Humira to children with polyarticular juvenile idiopathic arthritis below the age of 2
Danish: • Giv ikke Humira til børn under 2 år med polyartikulær juvenil idiopatisk artrit.
English: Amongst those who responded (Pediatric ACR 30) at Week 24 (n=27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received Humira throughout this time period.
Danish: Blandt de børn, som responderede (pædiatrisk ACR-30) ved uge 24 (n=27 ud af 30 patienter), blev pædiatrisk ACR 30-respons opretholdt i op til 60 uger i åben-label-fasen hos de patienter, som fik Humira gennem hele denne periode.
English: Patients were randomised to 40 mg of Humira or placebo every other week for 24 weeks.
Danish: Patienterne blev randomiseret til 40 mg Humira eller placebo hver anden uge i 24 uger.
English: Do not use the pre-filled syringe and call your doctor or pharmacist if the
Danish: Brug ikke den fyldte injektionssprøjte og kontakt din læge eller apotekspersonalet, hvis
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 Humira.
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 Humira.
English: Humira has been shown to slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.
Danish: Humira har vist sig at kunne nedsætte hastigheden for ødelæggelse af brusk og knogler i leddene forårsaget af sygdommen og at forbedre de fysiske funktioner.
English: In Psoriasis Study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at Week 33 compared to 5% continuing on Humira, p < 0.001, experienced “loss of adequate response” (PASI score after Week 33 and on or before Week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to Week 33).
Danish: I Psoriasis-studie I oplevede 28% af de patienter, som opnåede PASI 75-respons, og som blev genrandomiseret til placebo i uge 33, “tab af tilstrækkeligt respons” (PASI-score efter uge 33 og ved eller før uge 52, som resulterede i et <PASI 50-respons i forhold til baseline med en stigning på minimum 6 point i PASI-score i forhold til uge 33), sammenlignet med 5%, som fortsatte på Humira (p< 0,001).
English: The safety and efficacy of multiple doses of Humira were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Danish: Sikkerhed og effekt af gentagne doser af Humira blev undersøgt hos voksne patienter med moderat til svær aktiv colitis ulcerosa (Mayo-score 6 til 12 med endoskopi-subscore på 2 til 3) i randomiserede, dobbeltblinde placebokontrollerede studier.
English: Humira 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 (NSAIDs).
Danish: Aksial spondyloartritis uden radiografiske tegn på AS Humira 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 non-steroide anti-inflammatoriske lægemidler (NSAIDs).
English: In Study nr-axSpA I, Humira 40 mg every other week was assessed in 185 patients in a randomised, 12 week double - blind, placebo - controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with Humira 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: I Studie nr-axSpA I blev Humira 40 mg hver anden uge vurderet hos 185 patienter i et randomiseret, 12 ugers dobbeltblindet, placebokontrolleret studie hos patienter med aktiv nr-axSpA (gennemsnitlig baseline score for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,4 for patienter i behandling med Humira 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: All p-values are pairwise comparisons of proportions for Humira versus placebo p < 0.001 p < 0.01
Danish: Alle p-værdier er parvise sammenligninger af andelene for Humira vs. placebo * p<0,001 ** p<0,01
English: This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Should treatment be interrupted, Humira 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Danish: Hvis det bliver nødvendigt at afbryde behandlingen, kan der startes op igen med Humira 40 mg hver uge eller 80 mg hver anden uge (se pkt.
English: No malignancies were observed in 77 paediatric patients with an exposure of 80.0 patient years during a Humira trial in paediatric patients with chronic plaque psoriasis.
Danish: Der blev ikke observeret nogen maligniteter hos 77 pædiatriske patienter med en samlet eksponering på 80,0 patientår i Humira-studier hos pædiatriske patienter med kronisk plaque-psoriasis.
English: The third group received 40 mg of Humira every other week with placebo injections on alternate weeks.
Danish: Den tredje gruppe fik 40 mg Humira hver anden uge og placeboinjektioner i de øvrige uger.
English: Upon completion of the first 52 weeks, 457 patients enrolled in an open-label extension phase in which 40 mg of Humira/MTX was administered every other week up to 10 years.
Danish: Efter at have gennemført de første 52 uger blev 457 patienter optaget i et åbent forlængelsesstudie, hvor 40 mg Humira/MTX blev administreret hver anden uge i op til 10 år.
English: RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were  18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Danish: RA-studie I evaluerede 271 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel, hvor methotrexat i doser på 12,5 til 25 mg (10 mg ved methotrexat-intolerans) hver uge havde haft utilstrækkelig effekt, og hvor methotrexat-dosen forblev konstant på 10 til 25 mg hver uge.
English: 4) Throwing away supplies
Danish: 4) Bortskaffelse af udstyr
English: Of 207 patients, 81 patients continued on Humira 40 mg every other week for 10 years.
Danish: Ud af 207 patienter fortsatte 81 patienter på Humira 40 mg hver anden uge i 10 år.
English: The primary endpoint was the percent change from Baseline to Week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of62.6% (median percent change -88.9%) in patients in the Humira group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Danish: Det primære endepunkt var den procentvise ændring i antallet af led med aktiv artrit (hævelse, som ikke skyldes deformitet, eller led med tab af bevægelse plus smerte og/eller ømhed) fra baseline til uge 12, som blev opnået med et mediant fald på -62,6 % (median procentvise ændring -88,9 %) hos patienter i Humira-gruppen sammenlignet med et fald på -11,6 % (median procentvise ændring -50,0 %) hos patienter i placebo-gruppen.
English: Humira is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age.
Danish: Humira bruges til at behandle polyartikulær juvenil idiopatisk artrit hos patienter fra 2 år.
English: In patients with Crohn's disease, anti-adalimumab antibodies were identified in 7/269 subjects (2.6%) and in 19/487 subjects (3.9%) with ulcerative colitis.
Danish: Der blev identificeret anti-adalimumab-antistoffer hos 7/269 patienter (2,6%) med Crohns sygdom og hos 19/487 (3,9%) patienter med colitis ulcerosa.
English: Your child may first be given other disease-modifying medicines, such as methotrexate.
Danish: Dit barn kan først behandles med anden sygdomsdæmpende medicin såsom methotrexat.
English: Do not use the pre-filled syringe if expiry (EXP) date has passed.
Danish: Brug ikke den fyldte injektionssprøjte, hvis udløbsdatoen (EXP) er passeret.
English: Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies I − V. In these trials, 11.9% of patients treated with Humira and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at Week 24.
Danish: Patienter fik testet serumprøver for autoantistoffer på forskellige tidspunkter i reumatoid artrit-studie IV. I disse havde 11,9% af de Humira-behandlede patienter og 8,1% af de placebo- og aktiv kontrolbehandlede patienter med negative antinukleære antistoftitere ved baseline positive titere efter 24 uger.
English: • methotrexate
Danish: • methotrexat
English: The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table 11.
Danish: Fordelingen af patienter i henhold til alder samt modtaget minimums-, medianog maksimumsdosis i den åbne indkøringsfase er vist i tabel 11.
English: PsA Study I
Danish: PsA-studie I
English: • Hold the pre-filled syringe at eye level with one hand so you can see the air in the pre-filled syringe
Danish: • Hold den fyldte injektionssprøjte med en hånd, så du kan se luften i den fyldte injektionssprøjte.
English: • Ankylosing spondylitis,
Danish: • Ankyloserende spondylitis,
English: One pack contains 2 boxes, each containing 1 vial, 1 empty sterile syringe, 1 needle, 1 vial adapter and 2 alcohol pads.
Danish: En pakning indeholder 2 æsker hver med 1 hætteglas, en tom steril injektionssprøjte, 1 kanyle og 2 alkoholservietter.
English: 40 mg Humira every week
Danish: 40 mg Humira hver uge
English: Cholecystitis and cholelithiasis, hepatic steatosis, bilirubin increased
Danish: Ikke almindelig Kolecystit og cholelithiasis, Hepatisk steatose, forhøjet bilirubin
English: Your child's symptoms may return upon discontinuation.
Danish: Barnets symptomer kan komme igen efter ophør.
English: You will see the liquid medication from the vial go into the syringe.
Danish: Du kan se når den flydende medicin bliver trukket fra hætteglas over i sprøjten.
English: Keep this Patient Reminder Card with you.
Danish: Opbevar patientkortet på dig.
English: NN
Danish: SN NN
English: The safety and efficacy of Humira was assessed in an open-label, multicentre study in 32 children (2 - < 4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Danish: Humiras sikkerhed og virkning blev vurderet i et åben-label, multicenter studie med 32 børn (2 - <4 år gamle eller 4 år og derover med en vægt < 15 kg) med moderat til alvorlig aktiv polyartikulær JIA.
English: Humira has not been studied in patients with hepatic or renal impairment.
Danish: Humira er ikke undersøgt hos patienter med nedsat lever- eller nyrefunktion.
English: Methotrexate should be continued during treatment with Humira.
Danish: Der fortsættes med methotrexat under behandling med Humira.
English: A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with Humira.
Danish: Efter behandling med Humira blev også observeret et hurtigt fald i CRP-niveau hos patienter med polyartikulær juvenil idiopatisk artrit, Crohns sygdom, colitis ulcerosa og hidrosadenitis suppurativa.
English: Hold the pre-filled syringe in one hand.
Danish: Hold den fyldte injektionssprøjte i en hånd.