FrancophonIA/ELRC3.0 huggingface dataset:
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 adalimumab 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 studier rapporterede 11,9% af de adalimumab-behandlede patienter og 8,1% af de placeboog aktiv kontrolbehandlede patienter med negative antinukleære antistoftitre ved baseline positive titre ved uge 24.
English: Use one of the alcohol pads to wipe the stopper and then place the vial on a flat surface.
Danish: Brug den ene alkoholserviet til at rengøre hætteglassets prop, og sæt hætteglasset på et fladt underlag.
English: Adalimumab 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: Adalimumab 40 mg hver anden uge blev undersøgt i to randomiserede, 24 ugers dobbeltblindede 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: In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see Tables 17 and 18).
Danish: I Psoriasis-studie I og II var det primære endepunkt den andel af patienterne, som opnåede et PASI 75respons i forhold til baseline ved uge 16 (se tabel 17 og 18).
English: If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away.
Danish: Hvis du får feber, som ikke vil forsvinde, let får blå mærker eller bløder meget let eller ser meget bleg ud, skal du omgående henvende dig til din læge.
English: Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (<1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%).
Danish: På tværs af alle behandlingsgrupper var den gennemsnitlige baseline-PASI-score 19,7, og baseline-PGA-score varierede fra “mild” (< 1%) til moderat (48%) til “alvorlig” (46%) og “meget alvorlig” (6%).
English: Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Danish: Alvorlige infektioner, inklusive sepsis, forårsaget af bakterier, mykobakterier, invasive svampe, parasitter, virus eller andre opportunistiske infektioner såsom listeriose, legionellose og pneumocystis er blevet rapporteret hos patienter, som fik adalimumab.
English: ACR 50 week 12 week 24
Danish: ACR 50 Uge 12 Uge 24
English: • Do not give Hulio to children with plaque psoriasis below the age of 4 years.
Danish: • Giv ikke Hulio til børn under 4 år med plaque-psoriasis.
English: Step 1 - Choose and prepare injection site
Danish: Trin 1 - Vælg og klargør injektionssted
English: If you are injecting into the abdomen, choose a site that is at least 5 cm away from the belly button.
Danish: Hvis du injicerer på din mave (abdomen), skal du vælge et sted mindst 5 cm fra navlen.
English: If you forget to use Hulio
Danish: Hvis du har glemt at tage Hulio
English: If you received Hulio while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Danish: Hvis du har fået Hulio, mens du var gravid, kan dit spædbarn have en højere risiko for at få en sådan infektion i op til ca. fem måneder efter din sidste dosis under graviditeten.
English: Hulio 40 mg solution for injection in pre-filled syringe EU/1/18/1319/001
Danish: Hulio 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte EU/1/18/1319/001
English: Thereafter, the usual dose is 40 mg every other week.
Danish: Herefter er den sædvanlige dosis 40 mg hver anden uge.
English: If your child's doctor has told you that your child has an intolerance to some sugars or if your child has been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your child's doctor before you give your child this medicine.
Danish: Hvis din læge har fortalt dig, at dit barn har intolerance over for nogle sukkerarter, eller hvis dit barn er blevet diagnosticeret med arvelig fructoseintolerans (HFI), en sjælden genetisk lidelse, hvor en person ikke kan nedbryde fructose, skal du tale med barnets læge, før dit barn får dette lægemiddel.
English: ACR 70 week 12 week 24
Danish: ACR 70 Uge 12 Uge 24
English: • abnormal blood results;
Danish: • unormale blodprøveresultater;
English: In the open-label extension for RA study V, ACR response rates were maintained when followed for up to 10 years.
Danish: I det åbne forlængelsesstudie RA V blev ACR-respons bibeholdt, når patienterne blev fulgt i op til 10 år.
English: ACR 20 week 12 week 24
Danish: ACR 20 Uge 12 Uge 24
English: If you accidentally inject Hulio more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required.
Danish: Hvis du ved en fejltagelse injicerer Hulio hyppigere end foreskrevet, kontakt da lægen eller apotekspersonalet og fortæl dem, at du har taget for meget Hulio.
English: Table 17: Ps Study I (REVEAL) - Efficacy Results at 16 weeks Placebo N=398 n (%)
Danish: Ps-studie I (REVEAL) - Effektresultater ved uge 16 Placebo N=398 n (%)
English: For patients who are prescribed a dose less than 40 mg, Hulio 40 mg/0.8 ml solution for injection in a vial (available from your pharmacist) should be used.
Danish: Til patienter, som har fået ordineret en dosis, der er mindre end 40 mg, bør Hulio 40 mg/0,8 ml injektionsvæske i hætteglas anvendes (fås på apoteket).
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9; (p< 0.001) in the adalimumab group (at week 48).
Danish: Sammenlignet med placebo reducerede adalimumab progressionshastigheden, hvormed de perifere led destrueres, målt ved ændring i mTSS fra baseline (gennemsnit + SD) 0,8 ± 2,5 i placebogruppen (ved uge 24) sammenlignet med 0,0 ±1,9 i adalimumab-gruppen (ved uge 48) (p< 0,001).
English: Prescribers should exercise caution in considering the use of Hulio in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Hulio should be considered if any of these disorders develop.
Danish: Lægen bør udvise forsigtighed, når behandling med Hulio overvejes til patienter med allerede eksisterende eller nyligt opståede demyeliniserende sygdomme i centralnervesystemet eller det perifere, og seponering skal overvejes, hvis nogle af disse sygdomme forværres.
English: The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Danish: Adalimumabs sikkerhed og virkning er undersøgt i et randomiseret, dobbeltblindet, kontrolleret studie hos 90 pædiatriske patienter fra 2 til < 18 år med aktiv JIA-associeret non-infektiøs anterior uveitis, som var refraktære over for mindst 12 ugers behandling med methotrexat.
English: (N=305) (ASDAS < 1.3 at weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Danish: Patienter, som opnåede vedvarende remission i mindst 12 uger (N=305) (ASDAS < 1,3 ved uge 16, 20, 24, og 28) i den åbne periode, blev herefter randomiseret til at modtage enten fortsat behandling med adalimumab 40 mg hver anden uge (N=152) eller placebo (N=153) i yderligere 40 uger i den dobbeltblindede, placebokontrollerede periode (total studievarighed 68 uger).
English: a HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.
Danish: a HR af adalimumab vs. placebo ved regressionsanalyse med behandling som baggrundsvariabel.
English: If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or a rash do not inject them more Hulio and contact their doctor immediately since, in rare cases, these reactions can be life-threatening.
Danish: Hvis dit barn får allergiske reaktioner med symptomer såsom trykken i brystet, hvæsende vejrtrækning, svimmelhed, hævelser eller udslæt, så skal du undlade at injicere mere Hulio, og straks kontakte lægen, da disse reaktioner i sjældne tilfælde kan være livstruende.
English: There is limited safety experience in patients undergoing arthroplasty while receiving adalimumab.
Danish: Der er begrænset erfaring med sikkerheden hos patienter, som får artroplastik under behandling med adalimumab.
English: NA NA 4.5% 23.2% a RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate
Danish: NA 4,5% 23,2% a RA-studie I ved uge 24, RA-studie II ved uge 26 og RA-studie III ved ugerne 24 og 52 b 40 mg adalimumab givet hver anden uge c MTX = methotrexat
English: • worsening skin rash with muscle weakness.
Danish: • forværring af hududslæt ledsaget af muskelsvaghed.
English: Patients were randomised to receive either 24 mg/m2 body surface area (BSA) of adalimumab up to a maximum of
Danish: Patienterne blev randomiseret til at få enten adalimumab 24 mg/m2 legemsoverfladeareal (BSA) op til maksimalt
English: A 40 mg pen and a 40 mg prefilled syringe are also available for patients to administer a full 40 mg dose.
Danish: Der findes ligeledes en 40 mg pen og en 40 mg fyldt injektionssprøjte, så patienten kan indgive en fuld 40 mg dosis.
English: At week 16, more patients randomised to adalimumab 0.8 mg/kg had positive efficacy responses (e.g., PASI 75) than those randomised to 0.4 mg/kg eow or MTX.
Danish: Ved uge 16 havde flere af patienterne, som var randomiseret til adalimumab 0,8 mg/kg, positivt respons for effekt (f.eks. PASI 75) end dem, der var randomiseret til 0,4 mg/kg hver anden uge eller methotrexat.
English: REMINDER STICKERS TEXT (included in pack)
Danish: TEKST TIL HUSKEMÆRKATER (indeholdt i æsken)
English: In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see Tables 14 and 15).
Danish: I Psoriasis-studie I og II var det primære endepunkt den andel af patienterne, som opnåede et PASI 75respons i forhold til baseline ved uge 16 (se Tabel 14 og 15).
English: Hulio 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: Hulio 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: Children or adolescents with plaque psoriasis
Danish: Børn og unge med plaque-psoriasis
English: In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg adalimumab 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 adalimumab ved uge 0 og 80 mg ved uge 2 eller placebo i uge 0 og 2.
English: • 1 vial of Hulio solution (3)
Danish: • 1 hætteglas med Hulio-opløsning (3)
English: See the end of section 4 for how to report side effects.
Danish: 4, hvordan bivirkninger indberettes.
English: 40 mg Adalimumab every week
Danish: 40 mg adalimumab hver anden uge
English: If your child received Hulio while pregnant, your child's baby may be at higher risk for getting an infection for up to about five months after the last dose she received during her pregnancy.
Danish: Hvis dit barn har fået Hulio, mens hun var gravid, kan spædbarnet have en højere risiko for at få en infektion i op til ca. fem måneder efter hendes sidste dosis under graviditeten.
English: If your child develops a fever that does not go away, or bruises or bleeds very easily or look very pale, call your child's doctor right away.
Danish: Hvis dit barn får feber, som ikke vil forsvinde, let får blå mærker eller bløder meget let eller ser meget bleg ud, skal du omgående henvende dig til dit barns læge.
English: Based on the observed data approach, 222 (80.4%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7 %) were in steroid-free quiescence.
Danish: Baseret på anvendelse af observerede data var 222 (80,4%) inaktive (ingen aktive inflammatoriske læsioner, AC cell grade ≤ 0,5+, VH grad ≤ 0,5+) med en samtidig steroiddosis ≤ 7,5 mg pr. dag og 184 (66,7%) var både steroidfri og inaktive.
English: Always use this medicine exactly as your child's doctor or pharmacist has instructed.
Danish: Tag altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: Step 8 - Pull plunger to draw dose + 0.1 ml Keep the plunger rod pressed down and turn the connected syringe and vial upside down.
Danish: Trin 8 - Træk stempel til dosis + 0,1 ml Hold stempelstangen nede, og vend hætteglas og sprøjte på hovedet.
English: Hulio Dose for Paediatric Patients with Plaque Psoriasis Patient Weight
Danish: Hulio-dosis til pædiatriske patienter med plaque psoriasis Patientvægt
English: Hulio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Danish: Hulio er indiceret til behandling af moderat til svær kronisk plaque-psoriasis hos voksne patienter, hvor systemisk behandling er relevant.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
Danish: Polyartikulær juvenil idiopatisk artrit og entesopatirelateret artrit er sygdomme med betændelseslignende (inflammatoriske) reaktioner i leddene, der opstår i barndommen.
English: Step 12 - Prepare injection site
Danish: Trin 12 - Klargør injektionssted
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 Hulio.
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 Hulio.
English: Table 19: Maintenance regimen
Danish: Tabel 19: Vedligeholdelsesregime Patientvægt
English: Be careful to insert the needle so that it will not inject into your fingers holding the injection site.
Danish: Vær omhyggelig, når du stikker kanylen ind i huden, så du ikke stikker den i fingrene, der klemmer om injektionsstedet.
English: Table 14: Efficacy Response in Placebo-Controlled Study nr-axSpA I
Danish: Tabel 14: Respons på effektmål i placebokontrolleret Studie nr-axSpA I
English: In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
Danish: I et eksplorativt klinisk studie, hvor anvendelsen af en anden TNF-antagonist, infliximab, blev undersøgt hos patienter med moderat til svær kronisk obstruktiv lungesygdom (KOL), blev der rapporteret om flere maligniteter, primært i lunger eller hoved og hals, hos infliximab-behandlede patienter end hos kontrol-patienter.
English: It is recommended that your child uses an antiseptic wash daily on the affected areas during treatment with Hulio.
Danish: Det anbefales, at dit barn dagligt vasker de berørte områder med et antiseptisk middel under behandlingen med Hulio.
English: • symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
Danish: • symptomer på nerveforstyrrelser som f.eks. snurren og prikken, følelsesløshed, dobbeltsyn eller svaghed i arme og ben;
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years.
Danish: Der forekom ingen ALAT-stigninger ≥ 3 x ULN i fase 3-studiet med adalimumab hos patienter med polyartikulær juvenil idiopatisk artrit, som var fra 2 til < 4 år.
English: Medication Orange Indicator
Danish: Orange aktiveringsdel (Kanyle indvendig) Medicin Orange indikator
English: 4.5 Interaction with other medicinal products and other forms of interaction Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate.
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Adalimumab er blevet undersøgt hos patienter med reumatoid artrit, polyartikulær juvenil idiopatisk artrit og psoriasisartrit, der udelukkende blev behandlet med adalimumab og hos patienter, der også samtidigt tog methotrexat.
English: Each vial contains 38.2 mg sorbitol (E420).
Danish: Hvert hætteglas indeholder 38,2 mg sorbitol (E420).
English: Contents of the pack and other information Instructions for use
Danish: Pakningsstørrelser og yderligere oplysninger Brugsvejledning
English: If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Danish: Hvis din læge har fortalt dig at du (eller dit barn) har intolerance over for nogle sukkerarter eller hvis du er blevet diagnosticeret med arvelig fructoseintolerans (HFI), en sjælden genetisk lidelse, hvor en person ikke kan nedbryde fructose, skal du tale med din læge før du (eller dit barn) får dette lægemiddel.
English: interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis pleural effusion1)
Danish: interstitiel lungesygdom, kronisk obstruktiv lungesygdom, pneumonitis pleuraeffusion1)
English: The safety and efficacy of multiple doses of adalimumab 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 adalimumab 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, dobbeltblindede placebokontrollerede studier.
English: Table 24:
Danish: Tabel 24:
English: Table 15: Efficacy Response in Placebo-Controlled Period for Study nr-axSpA II Double-Blind
Danish: Tabel 15: Effekt-respons i den placebokontrollerede periode af Studie nr-axSpA II Dobbeltblind respons ved uge 68
English: The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg subcutaneous dosing every other week and every week.
Danish: Dalserumkoncentration af adalimumab ved steady state blev forøget omtrent proportionalt med dosis ved subkutan dosering af 20, 40 og 80 mg hver anden uge og hver uge.
English: Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Danish: Psoriasisartrit og aksial spondyloartritis inklusive ankyloserende spondylitis Det er ikke relevant at bruge adalimumab til den pædiatriske population til indikationerne ankyloserende spondylitis og psoriatrisartrit.
English: JSN score 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: JSN score ap-værdi for den parvise sammenligning af methotrexat-monoterapi og adalimumab/methotrexatkombinationeterapi ved anvendelse af Mann-Whitney U test. bp-værdi for den parvise sammenligning af adalimumab-monoterapi og adalimumab/methotrexatkombinationsterapi ved anvendelse af Mann-Whitney U test. cp-værdi for den parvise sammenligning af adalimumab-monoterapi og methotrexat-monoterapi ved anvendelse af Mann-Whitney U test.
English: In rheumatoid arthritis, methotrexate is continued while using Hulio.
Danish: Hvis du har reumatoid artrit, kan du fortsætte med methotrexat under behandling med Hulio.
English: When you are sure the adapter is attached to the vial, lift off the packaging.
Danish: Når du er sikker på, at hætteglasadapteren sidder fast på hætteglasset, kan indpakningen tages af hætteglasadapteren.
English: If you stop using Hulio
Danish: Hvis du holder op med at tage Hulio
English: • trouble breathing or swallowing;
Danish: • besvær med at trække vejret eller synke;
English: • signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
Danish: • tegn på infektion, såsom feber, kvalme, sår, tandproblemer, smerter ved vandladning, følelse af svaghed eller træthed, hoste;
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Danish: Disse studier omfattede patienter med reumatoid artrit af kortere og længere sygdomsvarighed, juvenil idiopatisk artrit (polyartikulær juvenil idiopatisk artrit og entesopatirelateret artrit) og patienter med aksial spondyloartritis (ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis (AS)), psoriasisartrit, Crohns sygdom, colitis ulcerosa, psoriasis, hidrosadenitis suppurativa og uveitis.
English: Step 15 - End of injection, remove syringe, engage needle cover When the syringe is empty, remove syringe and needle from the skin.
Danish: Trin 15 - Injektionen er udført, fjern sprøjte og påsæt kanylehus Når sprøjten er tom, trækkes kanylen ud af huden.
English: Hepatosplenic T-cell lymphoma1) Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Danish: Merkelcelle karcinom (kutant neuroendokrint karcinom)1)