FrancophonIA/ELRC3.0 huggingface dataset:
English: Warning: Do not detach the pink needle safety cover from the yellow connector.
Danish: Advarsel: Du må ikke fjerne den lyserøde kanylebeskyttelse fra den gule sprøjtekonnektor.
English: 1.3 Remove the box from the refrigerator (Figure B).
Danish: 1.3 Tag æsken ud af køleskabet (figur B).
English: In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Danish: I RA-studie IV var ACR 20-respons for patienter behandlet med adalimumab plus standardpleje statistisk signifikant bedre end for patienter behandlet med placebo plus standardpleje (p  0,001).
English: Kromeya can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Danish: Kromeya kan anvendes sammen med methotrexat eller visse sygdomsmodificerende antireumatiske lægemidler (sulfasalazin, hydroxychloroquin, leflunomid og guldpræparater til injektion), kortikosteroider eller smertemedicin, herunder non-steroide anti-inflammatoriske lægemidler (NSAIDs).
English: There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates the risk estimation.
Danish: Der er en øget baggrundsrisiko for lymfomer og leukæmi hos reumatoid artrit patienter med længerevarende, højaktiv, inflammatorisk sygdom, hvilket komplicerer risikoestimeringen.
English: • Children under 12 years of age are not allowed to inject themselves and injection must be done by a trained adult.
Danish: • Børn under 12 år må ikke indgive injektionen selv.
English: Population pharmacokinetic and pharmacokinetic/pharmacodynamic modelling and simulation predicted comparable adalimumab exposure and efficacy in patients treated with 80 mg every other week when compared with 40 mg every week (including adult patients with RA, HS, UC, CD or Ps, patients with adolescent HS, and paediatric patients ≥ 40 kg with CD).
Danish: Farmakokinetiske og farmakokinetiske/farmadynamiske populationsmodeller og simulering viser sammenlignelig adalimumab-eksponering og virkning hos patienter behandlet med 80 mg hver anden uge, når der sammenlignes med 40 mg hver uge (herunder voksne patienter med RA, HS, UC, CD eller psoriasis, unge patienter med HS og pædiatriske patienter ≥ 40 kg med CD).
English: Table 23 Maintenance regimen
Danish: Tabel 23 Vedligeholdelsesregime Patient vægt
English: 2 April 2019
Danish: Dato for første tilladelse: 2. april 2019.
English: After single intravenous doses ranging from 0.25 to 10 mg/kg, concentrations were dose proportional.
Danish: Efter enkeltvise intravenøse doser på mellem 0,25 og 10 mg/kg var koncentrationerne dosisrelaterede.
English: Diplopia
Danish: Diplopi
English: Warning: Do not remove the needle cap until you are ready to inject.
Danish: Advarsel: Du må ikke fjerne kanylehætten, før du er klar til at injicere.
English: 3.1 Check the transparent syringe housing to make sure that:
Danish: 3.1 Tjek det gennemsigtige sprøjtehus for at sikre:
English: Some of these hepatosplenic T-cell lymphomas with adalimumab have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for inflammatory bowel disease.
Danish: Nogle af disse hepatosplenisk T-celle lymfomer med adalimumab er forekommet hos unge voksne patienter i samtidig behandling med azathioprin eller 6mercaptopurin for inflammatorisk tarmsygdom.
English: Physicians should exercise caution when considering the use of Kromeya in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Danish: Læger bør være forsigtige, når de overvejer brug af Kromeya til patienter med anamnese af tilbagevendende infektioner eller med øvrige sygdomstilstande, som kan prædisponere patienterne for infektioner, inklusive samtidig anvendelse af immunsuppressive lægemidler.
English: • It is important to tell your doctor if your child has had or has a serious heart condition.
Danish: • Det er vigtigt at fortælle din læge, hvis dit barn har eller har haft en alvorlig hjertesygdom.
English: Statistically and clinically significant improvements from Baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Danish: Statistitisk og klinisk signifikante forbedringer fra baseline i livskvalitetsparametre (inklusive IMPACT III) blev også set i begge behandlingsgrupper.
English: It is very important that you tell your doctor if your child has ever had tuberculosis, or if he/she has been in close contact with someone who has had tuberculosis.
Danish: Det er meget vigtigt, at du informerer din læge, hvis dit barn nogensinde selv har haft tuberkulose, eller hvis dit barn har været i tæt kontakt med nogen, som har haft tuberkulose.
English: Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Danish: Lymfom**, solide organ-neoplasmer (inklusive brystkræft, lungekræft og thyroideakræft), melanom**
English: A patient who requires surgery while on Kromeya should be closely monitored for infections, and appropriate actions should be taken.
Danish: En patient, som har behov for et kirurgisk indgreb under behandling med Kromeya, bør monitoreres tæt for infektioner, og der skal tages passende forholdsregler.
English: Similar remission rates were observed for the 160/80 mg and 80/40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/80 mg group.
Danish: Der sås sammenlignelige remissions-rater ved uge 8 for 160/80 mg og 80/40 mg induktionsregimerne, men bivirkninger var hyppigere i gruppen med 160/80 mg.
English: Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Danish: Aorta-anurisme, vaskulær arteriel okklusion, tromboflebit
English: TREATMENT FAILURE RATE (%)
Danish: BEHANDLINGSSVIGT (%)
English: Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
Danish: Adalimumab binder specifikt til TNF og neutraliserer dennes biologiske funktion ved at blokere dens interaktion med celleoverflade-TNF-receptorerne p55 og p75.
English: All patients received a 2-week standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by week 15.
Danish: Ved studiestart fik alle patienter standarddosis af prednison 60 mg/dag i 2 uger efterfulgt af en obligatorisk nedtrapningsplan med komplet seponering af kortikosteroid ved uge 15.
English: The conduct and results of these tests should be recorded on your child's patient reminder card.
Danish: Disse undersøgelser og resultaterne heraf bør registreres på dit barns patientkort.
English: This study evaluated the efficacy of adalimumab 40 mg every other week/methotrexate combination therapy, adalimumab 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Danish: Dette studie vurderede virkningen af adalimumab 40 mg hver anden uge/methotrexat-kombinationsterapi, adalimumab monoterapi 40 mg hver anden uge og methotrexat-monoterapi med hensyn til reduktion af tegn, symptomer og hastigheden af progressionen af ledskader ved reumatoid artrit i 104 uger.
English: Corticosteroids or other medicines that influence the immune system may be continued while using Kromeya.
Danish: Du kan fortsætte med at bruge kortikosteroider eller andre lægemidler, som påvirker immunsystemet, imens du tager Kromeya.
English: Use a new pre-filled syringe instead.
Danish: Brug en ny fyldt injektionssprøjte i stedet for.
English: Sodium hydroxide (for pH adjustment) Water for injections
Danish: Natriumhydroxid (til pH-justering) Vand til injektionsvæsker
English: Adults with rheumatoid arthritis
Danish: Voksne med reumatoid artrit
English: Excipients with known effects
Danish: Hjælpestoffer med kendt virkning
English: Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment.
Danish: Tilgængelige data tyder på, at klinisk respons normalt opnås inden for 2-8 ugers behandling.
English: Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg/day) at baseline to control their disease.
Danish: Studie UV II undersøgte 226 patienter med inaktiv uveitis, hvor kronisk kortikosteroidbehandling (oral prednison 10 til 35 mg/dag) ved baseline var nødvendig for at kontrollere sygdommen.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 24.
Danish: Rater for klinisk remission og klinisk respons (defineret som reduktion i PCDAI-score på mindst 15 point fra baseline) er vist i tabel 24.
English: • Do not use an Kromeya pre-filled pen that has been frozen or left in direct sunlight.
Danish: • Du må ikke bruge en Kromeya fyldt pen, der har været frossen eller har ligget i direkte sollys.
English: PGA: Clear/minimal c a
Danish: PGA: Clear/minimal
English: 6.2 With a quick, short motion, push the needle into the skin at an angle of 45°.
Danish: 6.2 Før kanylen ind i huden med en hurtig, kort bevægelse i en vinkel på 45°.
English: Leucocytosis, thrombocytopenia
Danish: Leukocytose, trombocytopeni
English: • Do not give Kromeya to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.
Danish: • Giv ikke Kromeya til børn under 2 år med polyartikulær juvenil idiopatisk artrit.
English: 5.4 Hold the syringe like a pencil with the pink needle safety cover pointing up
Danish: 5.4 Hold sprøjten som en blyant med den lyserøde kanylebeskyttelse pegende opad.
English: • Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Kromeya in case they cause infections.
Danish: • Visse vacciner indeholder levende men svækkede former for sygdomsfremkaldende bakterier eller virusser og bør ikke gives under behandling med Kromeya i tilfælde af, at de giver infektioner.
English: Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10% (60% of patients) and BSA < 10% and ≥ 5% (40% of patients)).
Danish: Adalimumab viste en behandlingsfordel hos patienter med neglepsoriasis med forskellig omfang af hudinvolvering (BSA≥10% (60 % af patienterne) og BSA<10% og ≥5% (40 % af patienterne)).
English: Because of the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-antagonists.
Danish: På grund af typen af bivirkningerne observeret ved kombinationen af etanercept og anakinra er der risiko for lignende toksicitet ved kombination af anakinra og andre TNFantagonister.
English: These results suggest that some patients who have not responded by week 4 benefit from continued maintenance therapy through week 12.
Danish: Disse resultater tyder på, at nogle patienter, som ikke har responderet ved uge 4, har fordel af fortsat vedligeholdelsesbehandling til og med uge 12.
English: Injection site reaction (including injection site erythema)
Danish: Meget almindelig Reaktioner på injektionsstedet (inklusive erytem på injektionstedet)
English: 1.7 Leave the pre-filled pen at room temperature for at least 30 minutes to allow the medicine to warm up (Figure F).
Danish: 1.7 Lad den fyldte pen hvile ved stuetemperatur i mindst 30 minutter, så lægemidlet kan blive varmet op (figur F).
English: Patients received either placebo or 20 mg adalimumab (if < 30 kg) or 40 mg adalimumab (if ≥ 30 kg) every other week in combination with their baseline dose of methotrexate.
Danish: Patienterne fik enten placebo eller 20 mg adalimumab (hvis < 30 kg) eller 40 mg adalimumab (hvis > 30 kg) hver anden uge i kombination med deres baseline dosis af methotrexat.
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 adalimumab therapy.
Danish: Før behandling med adalimumab påbegyndes, anbefales det, hvis det er muligt, at bringe pædiatriske patienter ajour med alle immuniseringer i overenstemmelse med gældende immuniseringsvejledninger.
English: Your symptoms may return upon stopping treatment.
Danish: Dine symptomer kan komme igen efter ophør med behandlingen.
English: In RA studies I-IV, adalimumab-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Danish: I RA-studie I-IV opnåede adalimumab-behandlede patienter statistisk signifikant ACR 20- og 50respons sammenlignet med placebo allerede én til to uger efter behandlingsstart.
English: On rare occasions, a specific and severe type of lymphoma, has been observed in patients taking adalimumab.
Danish: I sjældne tilfælde er der set en specifik og alvorlig type af lymfom hos patienter, der tog adalimumab.
English: The results for the 40 mg every other week dose are summarised in Table 9.
Danish: Resultaterne for 40 mg hver anden uge er opstillet i tabel 9.
English: a partial remission ASDAS
Danish: ASASa Delvis Remission
English: Figure I Warning: Do not use the syringe if it shows any sign of damage.
Danish: Figur I Advarsel: Du må ikke bruge injektionssprøjten, hvis den viser tegn på skade.
English: 6.3 Administer the Injection
Danish: 6.3 Indgiv injektionen
English: • The glass syringe is not cracked or broken (Figure H).
Danish: • at glassprøjten ikke er beskadiget eller revnet (figur H)
English: Thirty-three (18%) 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: Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015
Danish: 14 uger a Pædiatrisk ACR 30/50/70-responser ved uge 48 er signifikant bedre end responserne for placebobehandlede patienter b p = 0,015 c p = 0,031
English: • Certain vaccines contain living but weakened forms of bacteria or disease-causing bacteria or viruses and should not be given during treatment with Kromeya in case they cause infections.
Danish: • Visse vacciner indeholder levende men svækkede former for bakterier eller sygdomsfremkaldende bakterier eller virusser og bør ikke gives under behandling med Kromeya i tilfælde af, at de giver infektioner.
English: Adalimumab/MTX 40 mg every other week
Danish: Adalimumab/MTX 40 mg hver anden uge
English: Discontinued corticosteroids
Danish: Seponering af kortikosteroider
English: The second received 20 mg of adalimumab every week for 52 weeks.
Danish: Den anden fik 20 mg Adalimumab hver uge i 52 uger.
English: Worsening of symptoms of dermatomyositis
Danish: Forværring af dermatomyositis-symptomer1)
English: PsA study II with 12 -week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Danish: I PsA-studie II blev 100 patienter, som havde utilstrækkeligt respons på DMARD-terapi, behandlet i 12 uger.
English: In study I, improvements in the physical and mental component summary scores of the SF-36 were also significant compared to placebo.
Danish: I studie I var der også signifikante forbedringer i den fysiske og mentale komponent i den sammensatte SF-36-score sammenlignet med placebo.
English: After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.
Danish: Efter induktionsbehandling, er den anbefalede dosis 40 mg hver anden uge via subkutan injektion.
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Kromeya (see section 4.4).
Danish: Oftamologer rådes til at konsultere en passende specialist inden initering af behandling med Kromeya (se pkt.
English: This will include a thorough medical evaluation including your child's medical history and screening tests (for example chest X-ray and a tuberculin test).
Danish: Dette vil omfatte en omhyggelig gennemgang af dit barns sygdomshistorie og screeningstest (f. eks. røntgenundersøgelse af lunger og en tuberkulintest).
English: • The Kromeya pre-filled pen comes as a ready to use single-use pre-filled pen to give a full dose of adalimumab.
Danish: • Kromeya fyldt pen er en engangspen, som er klar til brug og giver en fuld dosis adalimumab.
English: Step 3 Check the Pre-filled Pen
Danish: Trin 3 Tjek den fyldte pen
English: • Tell your doctor if your child has a history of recurrent infections or other conditions that increase the risk of infections.
Danish: • Fortæl din læge, hvis dit barn har en sygdomshistorie med gentagne infektioner eller andre forhold, der forøger risikoen for infektioner.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 18.
Danish: Rater for klinisk remission og klinisk respons (defineret som reduktion i PCDAI-score på mindst 15 point fra baseline) er vist i tabel 18.
English: Warning: Do not blow on or touch the injection site after cleaning.
Danish: Advarsel: Du må ikke puste på eller røre ved injektionsstedet, når du har renset det.
English: Your child's doctor should test your child for HBV. Adalimumab can reactivate HBV infection in people who carry this virus.
Danish: Dit barns læge vil teste dig for HBV. Adalimumab kan reaktivere af HBV-infektion hos mennesker, der bærer denne virus.
English: This will include a thorough medical evaluation including your medical history and screening tests (for example chest X-ray and a tuberculin test).
Danish: Dette vil omfatte en omhyggelig gennemgang af din sygdomshistorie og screeningstest (f. eks. røntgenundersøgelse af lunger og en tuberkulintest).
English: • angioedema (localized swelling of the skin);
Danish: • angioødem (lokal hævelse af huden)
English: 2.2 Check the label on the vial for Kromeya and expiration date.
Danish: 2.2 Tjek, at der står Kromeya på hætteglassets etiket, og tjek udløbsdatoen.
English: No studies have been conducted that include patients with a history of malignancy or in whom treatment with adalimumab is continued following development of malignancy.
Danish: Der er ikke gennemført nogen studier med patienter, der tidligere har haft maligniteter, eller hos hvem behandling med adalimumab er fortsat med efterfølgende udvikling af maligniteter.
English: If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for your child.
Danish: Hvis dit barn har KOL, eller ryger meget, bør du diskutere med din læge, om behandling med en TNFα-hæmmer er passende for dit barn.
English: If you become pregnant, you should see your doctor.
Danish: Hvis du bliver gravid, skal du kontakte din læge.
English: Kromeya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: Kromeya kan gives som monoterapi i tilfælde af intolerans over for methotrexat eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: When Kromeya therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
Danish: Når Kromeya behandlingen påbegyndes kan en induktionsdosis på 40 mg til patienter < 30 kg eller 80 mg til patienter ≥ 30 kg administreres en uge før start af vedligeholdelsesdosis.
English: Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti−rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Danish: Nioghalvfjerds (20,1%) af patienterne blev samtidigt behandlet med sygdomsmodificerende antireumatiske lægemidler, og 37 (9,4 %) af patienterne med glukokortikoider.
English: • There have been cases of cancers, other than lymphoma, in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker.
Danish: • Der har været tilfælde af kræft, der er forskellig fra lymfom hos patienter med en specifik type lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL), der var i behandling med en anden TNFα-hæmmer.
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check your child for signs and symptoms of tuberculosis before starting Kromeya.
Danish: • Eftersom der har været rapporteret tilfælde af tuberkulose hos patienter i behandling med adalimumab, vil din læge undersøge dit barn for tegn og symptomer på tuberkulose, før behandling med Kromeya påbegyndes.
English: After Injection
Danish: Efter injektion
English: At week 52, 42.9% of patients who received adalimumab/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 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: • Kromeya pre-filled syringe has a clear needle guard that covers the needle after the injection is complete.
Danish: • Kromeya fyldt injektionssprøjte har en gennemsigtig kanylebeskyttelse, der dækker kanylen, når injektionen er udført.
English: The results for the 40 mg every other week dose are summarised in Table 7.
Danish: Resultaterne for 40 mg hver anden uge er opstillet i tabel 7.
English: Kromeya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Danish: Kromeya er i kombination med methotrexat indiceret til behandling af aktiv polyartikulær juvenil idiopatisk artrit hos patienter fra 2 år, som har haft et utilstrækkeligt respons på en eller flere sygdomsmodificerende anti-reumatiske lægemidler (DMARDs).
English: ▪ the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Danish: • behandling af alvorlig, aktiv og progressiv reumatoid artrit hos voksne patienter, som ikke tidligere er blevet behandlet med methotrexat.
English: Week 52 open-label
Danish: Uge 52 Åbent
English: This risk may increase if his/her lung function is reduced.
Danish: Risikoen kan stige, hvis hans/hendes lungefunktion er nedsat.
English: Week 4
Danish: Uge 4
English: Sarcoidosis1), vasculitis
Danish: Sarkoidose1) vaskulitis
English: Patients who achieved sustained remission for at least 12 weeks (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 studie varighed 68 uger).