FrancophonIA/ELRC3.0 huggingface dataset:
English: Of those in clinical response at week 4, 48 % had been previously exposed to other TNFantagonists.
Danish: Blandt patienter med klinisk respons i uge 4 havde 48 % tidligere været eksponeret for anden TNF-antagonist.
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post marketing setting.
Danish: Der er rapporteret om maligne lidelser, i visse tilfælde letale, hos børn, unge og unge voksne (i alderen op til 22 år), som blev behandlet med TNF-antagonister (initiering af behandling før 18-års alderen), inklusive adalimumab i perioden efter markedsføring.
English: Of those patients who had a response at week 8, 47 % were in response, 29 % were in remission, 41 % had mucosal healing, and 20 % were in steroid-free remission for ≥ 90 days at week 52.
Danish: Blandt de patienter, som havde et respons ved uge 8, var 47 % i respons, 29 % var i remission, 41 % havde slimhindeheling, og 20 % var i steroid-fri remission i ≥ 90 dage ved uge 52.
English: They are displayed by system organ class and frequency in Table 6 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Danish: Nedenstående liste over bivirkninger er baseret på erfaring fra kliniske studier og erfaring efter markedsføring og er inddelt efter organklassesystem og hyppighed i tabel 6 nedenfor: meget almindelig (≥ 1/10); almindelig( ≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: You will inject into this raised area of
Danish: Du skal injicere i det løftede hudområde.
English: Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg/kg/day or 10 mg/day maximum).
Danish: Patienterne fortsatte på faste doser NSAID og/eller prednison (≤ 0,2 mg/kg/dag eller maksimalt 10 mg/dag).
English: This evaluation should include colonoscopy and biopsies per
Danish: Denne vurdering bør omfatte koloskopi og biopsier i henhold til lokale anbefalinger.
English: By attaching to TNFα, Cyltezo decreases the process of inflammation in these diseases.
Danish: Ved at binde sig til TNFα nedsætter Cyltezo betændelsesprocessen for disse sygdomme.
English: * p value for Standard Dose versus Low Dose comparison.
Danish: * p-værdi for sammenligning af standarddosis versus lavdosis.
English: The adjusted OR (accounting for baseline differences) was 1.10 (95 % CI 0.45-2.73) with RA and CD combined.
Danish: Den korrigerede OR (som tager højde for baseline forskelle) var 1,10 (95 % konfidensinterval 0,45-2,73) for RA og CD kombineret.
English: Time to Treatment Failure in Studies UV I and UV II
Danish: Tid til behandlingssvigt i studie UV I og UV II
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 forskelligt omfang af hudinvolvering (BSA ≥ 10 % (60 % af patienterne) og BSA < 10 % og ≥ 5 % (40 % af patienterne)).
English: The frequency of serious infections among adalimumab treated subjects over 65 years of age (3.7 %) was higher than for those under 65 years of age (1.5 %).
Danish: Hyppigheden af alvorlige infektioner var højere hos adalimumab-behandlede patienter over 65 år (3,7 %) end hos patienter under 65 år (1,5 %).
English: Patients who develop a new infection while undergoing treatment with Cyltezo should be monitored closely and undergo a complete diagnostic evaluation.
Danish: Patienter, der udvikler en ny infektion under behandling med Cyltezo, bør monitoreres nøje og gennemgå en fuldstænding diagnostisk evaluering.
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 µg/mL
Danish: Den tilsyneladende plasmakoncentation af adalimumab som giver 50 % sandsynlighed for PedACR 50 respons (EC50) var
English: Note: Treatment failure at or after week 6 (Study UV I), or at or after week 2 (Study UV II), was counted as event.
Danish: Note: Behandlingssvigt i eller efter uge 6 (Studie UV I) eller i eller efter uge 2 (Studie UV II) blev talt med som hændelser.
English: • Do not select tender, bruised, or scarred areas.
Danish: • Der må ikke vælges ømme områder, blå mærker eller områder med ar.
English: • Do not rub the injection site.
Danish: • Der må ikke gnides på injektionsstedet.
English: However, there have also been postmarketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Danish: Der har imidlertid også været rapporter i perioden efter markedsføring om leversvigt samt mindre alvorlige leverlidelser, som kan optræde forud for leversvigt, såsom hepatit, inklusive autoimmun hepatit, hos patienter, som
English: • If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Cyltezo and contact your doctor immediately since, in rare cases, these reactions
Danish: • Hvis du har allergiske reaktioner med symptomer som trykken i brystet, hvæsende vejrtrækning, svimmelhed, hævelser eller udslæt, så undlad at injicere mere Cyltezo, og kontakt straks lægen, da disse reaktioner i sjældne tilfælde kan være livstruende.
English: Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients)
Danish: Respons, remission og slimhindeheling i studie UC-II (Procentdel af patienter)
English: 40 mg every other week - Not applicable.
Danish: 40 mg hver anden uge - Ikke relevant.
English: What you need to know before you use Cyltezo
Danish: Det skal du vide, før du begynder at bruge Cyltezo
English: • worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).
Danish: • forværring af en tilstand, som kaldes dermatomyositis (ses som hududslæt ledsaget af
English: For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Cyltezo should be promptly discontinued.
Danish: For patienter, som udvikler tegn og symptomer såsom feber, utilpashed, vægttab, svedeture, hoste, dyspnø, og/eller pulmonale infiltrater eller anden alvorlig systemisk sygdom med eller uden samtidig shock, bør en invasiv svampeinfektion mistænkes, og administration af Cyltezo skal omgående afbrydes.
English: Side effects may occur up to 4 months or more after the last Cyltezo injection.
Danish: Bivirkninger kan forekomme op til 4 måneder eller længere efter den sidste
English: At week 16, a statistically significantly greater proportion of patients who received adalimumab achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6 % versus 4.3 %, respectively [p = 0.014]).
Danish: Ved uge 16 havde en statistisk signifikant større andel af de patienter, som fik adalimumab opnået PGA ”clear” eller ”almost clear” for psoriasis på hænder og/eller fødder sammenlignet med patienter, som fik placebo (30,6 % versus 4,3 % [p = 0,014]).
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, eller du let får blå mærker eller bløder eller er meget bleg, skal du omgående henvende dig til din læge.
English: A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be
Danish: En risiko for udvikling af maligniteter hos børn og unge behandlet med TNF-antagonister kan ikke udelukkes.
English: o Press injection button once (you should hear a ‘click' that indicates the start of injection) and keep pen pressed firmly against skin while you slowly count to 10.
Danish: • Administrer hele dosis: o Tryk på injektionsknappen én gang (du vil høre et 'klik', der indikerer starten på injektionen), og hold pennen trykket fast mod huden, mens du langsomt tæller til 10. o Flyt ikke pennen under injektionen.
English: In post-marketing experience from January 2003 to December 2010, predominantly in patients with rheumatoid arthritis, the reported rate of malignancies is approximately 2.7 per 1,000 patient treatment years.
Danish: Der er ved erfaring i perioden efter markedsføring fra januar 2003 til december 2010, hovedsageligt hos patienter med reumatoid artrit, rapporteret en hyppighed af maligniteter på cirka 2,7 pr.
English: • Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of
Danish: • Fortæl lægen, hvis du har en sygdomshistorie med gentagne infektioner eller andre tilfælde, der
English: The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 5.9 % for patients taking adalimumab and 5.4 % for control treated
Danish: Andelen af patienter, som ophørte med behandling på grund af bivirkninger i løbet af den dobbeltblindede, kontrollerede del af de pivotale studier, udgjorde 5,9 % for patienter, der fik adalimumab, og 5,4 % for kontrolbehandlede patienter.
English: Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposure response relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Danish: Adalimumabs virkning til behandling af unge patienter med HS er baseret på den demonstrerede virkning og eksponeringsresponsforholdet hos voksne HS-patienter og sandsynligheden for, at sygdomsforløb, patofysiologi og lægemidlets virkning i det væsentligste svarer til voksnes ved samme eksponeringsniveau.
English: • opportunistic infections (which include tuberculosis and other infections that occur when resistance to
Danish: • opportunistiske infektioner (som inkluderer tuberkulose og andre infektioner, som forekommer,
English: An embryo-foetal developmental toxicity/perinatal developmental study has been performed in cynomolgus monkeys at 0, 30 and 100 mg/kg (9-17 monkeys/group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Danish: Et embryoføtalt udviklingstoksicitet-/perinatalt udviklingsstudie foretaget på cynomolgusaber med 0, 30 og 100 mg/kg (9-17 aber/gruppe) viste ingen tegn på fosterskader på grund af adalimumab.
English: • Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);
Danish: • Stevens-Johnsons syndrom (tidlige symptomer inkluderer utilpashed, feber, hovedpine og
English: If active tuberculosis is diagnosed, Cyltezo therapy must not be initiated (see section 4.3).
Danish: Hvis der diagnosticeres aktiv tuberkulose, må Cyltezo-terapi ikke påbegyndes (se pkt.
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX-treated.
Danish: I den åbne indkøringsfase blev patienterne stratificeret i to grupper - MTX-behandlede (methotrexat-behandlede) og ikke-MTXbehandlede.
English: These include rare reports of pancytopenia, aplastic anaemia, central and peripheral demyelinating events and reports of lupus, lupus-related conditions and Stevens-Johnson syndrome.
Danish: Disse omfatter sjældne rapporter om pancytopeni, aplastisk anæmi, central og perifer demyeliniseringsforstyrrelser samt rapporter om lupus, lupus-relaterede tilstande og Stevens-Johnson syndrom.
English: 8) Before injecting, read steps A-C to learn correct way to administer dose.
Danish: 8) Læs trin A-C før injektionen, så du lærer den korrekte måde at administrere dosis på.
English: Your doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the
Danish: Din læge kan også ordinere en induktionsdosis på 80 mg, som kan administreres en uge før start af den
English: A single Cyltezo pre-filled syringe/pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Danish: En enkelt Cyltezo fyldt injektionssprøjte/fyldt pen kan opbevares ved temperaturer på op til maksimalt 25 °C i en periode på op til 14 dage.
English: Patients treated with Cyltezo should be given the patient alert card.
Danish: Patienter i Cyltezo-behandling bør få udleveret et patientkort.
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 lungesygdom kaldet kronisk obstruktiv lungesygdom (KOL), der var i behandling med en anden TNFα-hæmmer.
English: Adalimumab significantly decreased the risk of treatment failure by 75 % relative to placebo, as shown by the hazard ratio (HR = 0.25 [95 % CI: 0.12, 0.49]).
Danish: Adalimumab nedsætter signifikant risikoen for behandlingssvigt med 75 %, som vist med hazard ratio sammenlignet med placebo (HR = 0,25 [95 % CI: 0,12; 0,49]).
English: A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4 % vs. 47.1 %, p < 0.001) (Figure 1).
Danish: En større del af patienterne på adalimumab havde ingen opblussen af sygdommen i den dobbeltblinde periode ved sammenligning med dem på placebo (70,4 % versus 47,1 %, p < 0.001) (figur 1).
English: Cyltezo can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Danish: Cyltezo kan gives som monoterapi i tilfælde af intolerans over for methotrexat, eller hvis fortsat behandling med methotrexat er uhensigtsmæssig.
English: Similar trends (not all statistically significant) were seen in the smaller randomised, double-blind, placebo-controlled AS study II of 82 adult patients with active ankylosing spondylitis.
Danish: Lignende tendenser (ikke alle statistisk signifikante) blev set i det mindre, randomiserede, dobbeltblindede, placebokontrollerede AS-studie II på 82 voksne patienter med aktiv ankyloserende
English: Induction of Clinical Remission and Response (Percent of Patients)
Danish: Induktion af klinisk remission og respons (Procentdel af patienterne)
English: The efficacy of adalimumab in those patients was reduced compared to that in anti-TNF naïve patients.
Danish: Virkningen af adalimumab var nedsat hos disse patienter sammelignet med anti-TNF-naive patienter.
English: Formation of anti-adalimumab antibodies is associated with increased clearance and reduced efficacy of adalimumab.
Danish: Dannelse af adalimumab-antistoffer er forbundet med øget clearence og reduceret virkning af adalimumab.
English: The Cyltezo pre-filled pen is available in packs containing 1, 2, 4 and 6 pre-filled pens.
Danish: Cyltezo fyldt pen fås i pakninger indeholdende 1, 2, 4 og 6 fyldte penne.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Cyltezo should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en anafylaktisk reaktion eller andre alvorlige allergiske reaktioner, bør behandling med Cyltezo straks ophøre og egnet behandling påbegyndes.
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra studier af toksicitet efter enkeltdosering, toksicitet efter gentagne doser og genotoksicitet.
English: The Guide for healthcare professionals shall contain the following key elements:
Danish: Vejledningen til læger og sundhedspersonale skal indeholde de følgende nøgleelementer:
English: • If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Cyltezo.
Danish: • Hvis du har en infektion, herunder langvarig eller lokaliseret infektion (f.eks sår på benet), bør du kontakte din læge, før du begynder at bruge Cyltezo.
English: Preclinical data on postnatal toxicity of adalimumab are not available (see
Danish: Prækliniske data for adalimumab om postnatal toksicitet findes ikke (se pkt.
English: • Inspect Cyltezo pen, medication and expiration date.
Danish: • Inspicer Cyltezo-pennen, lægemidlet og udløbsdatoen.
English: Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Danish: Adalimumab/methotrexatkombinationsterapi var klinisk og statistisk bedre end methotrexat-monoterapi (p < 0,001) og adalimumab-monoterapi (p < 0,001) i opnåelsen af lav sygdomstilstand hos patienter med nylig diagnosticeret moderat til alvorlig reumatoid artrit.
English: You should record the date when the syringe is first removed from refrigerator and the date after which it
Danish: Du skal registrere den dato, hvor injektionssprøjten først tages ud af køleskabet, og den dato efter
English: The proportions of subjects with PedACR50/70/90 at week 12 and week 24 were 90.3 %/61.3 %/38.7 % and 83.3 %/73.3 %/36.7 %, respectively.
Danish: Forholdet mellem patienter med pædiatrisk ACR 50/70/90 ved uge 12 og uge 24 var henholdsvis 90,3 %/61,3 %/38,7 % og 83,3 %/73,3 %/36,7 %.
English: Thus, it is not possible to administer Cyltezo to paediatric patients that require less than a full 40 mg dose.
Danish: Det er derfor ikke muligt at administrere Cyltezo til pædiatriske patienter, som har behov for mindre end en fuld 40 mg dosis.
English: Administration of live vaccines (e.g. BCG vaccine) to infants exposed to Cyltezo in utero is not recommended for 5 months following the mother's last Cyltezo injection during pregnancy.
Danish: Administration af levende vacciner (f.eks. BCG-vaccine) til spædbørn, som har været eksponeret for Cyltezo i utero, anbefales ikke i 5 måneder efter moderens sidste Cyltezo-injektion under graviditeten.
English: Use of anti-tuberculosis prophylaxis treatment should also be considered before the initiation of Cyltezo in patients with several or significant risk factors for tuberculosis despite a negative test for tuberculosis and in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot
Danish: Inden start af behandling med Cyltezo skal profylaktisk behandling mod tuberkulose også overvejes hos patienter med adskillige eller signifikante risikofaktorer for tuberkulose på trods af en negative test for tuberkulose samt hos patienter, der tidligere har haft latent eller aktiv tuberkulose, hvor det ikke har kunnet bekræftes, at behandlingen har været tilstrækkelig.
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9 %) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Danish: Blandt de 68 patienter, som havde opblussen af sygdom i gruppen, som var allokeret til seponering af behandling, fuldførte 65 patienter 12 ugers rescue-behandling med adalimumab, ud af hvilke 37 (56,9 %) genvandt remission (ASDAS < 1.3) 12 uger efter genstart af behandling i den åbne periode.
English: Cyltezo is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Danish: Cyltezo bruges til at behandle polyartikulær juvenil idiopatisk artrit hos børn og unge i alderen 2 til 17 år og entesopatirelateret artrit hos børn og unge i alderen 6-17 år.
English: N Failure N (%)
Danish: BEHANDLINGSSVIGT (%)
English: The 1 pre-filled pen pack comes with 2 alcohol pads (1 spare).
Danish: Pakningen med 1 fyldt pen leveres med 2 alkoholservietter (1 ekstra).
English: Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post
Danish: immunmodulerende lægemidler kunne kun seponeres ved eller efter uge 26 efter investigators skøn, hvis patienten defineret som lukning af alle fistler, som var åbne ved baseline, ved mindst 2 på hinanden følgende besøg efter baseline
English: In general, the adverse events in paediatric patients were similar in frequency and type to those seen in adult
Danish: Generelt var bivirkningerne i hyppighed og type hos pædiatriske patienter tilsvarende dem, som blev
English: Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment.
Danish: Patienter med minimum et delvist respons på adalimumab 40 mg ugentlig efter 12 ugers behandling.
English: Following 3 years of adalimumab therapy, 75 % (301/402) continued to be in clinical remission per partial Mayo score.
Danish: Efter 3 års behandling med adalimumab fortsatte 75 % (301/402) med at være i klinisk remission i forhold til partiel Mayo-score.
English: Anti-adalimumab antibodies may develop during adalimumab treatment.
Danish: Der kan udvikles antistoffer mod adalimumab under behandlingen med adalimumab.
English: Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Danish: Samtidig administration af adalimumab og andre biologiske DMARDs (f.eks. anakinra og abatacept) eller andre TNF-antagonister anbefales ikke på grund af en øget risiko for infektioner, herunder alvorlige infektioner og andre potentielle farmakologiske interaktioner (se pkt.
English: Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis.
Danish: Rapporterne indeholder tilfælde af lungetuberkulose og ekstra-pulmonal (f.eks.
English: Percent of patients achieving PASI75 response was calculated as centre-adjusted rate
Danish: a Procentdel af patienterne, som opnåede PASI 75-respons beregnet med justering for center variation
English: Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Danish: Fortæl straks din læge, hvis du får symptomer som ændringer i dit syn, svaghed i arme eller ben eller følelsesløshed eller en snurrende fornemmelse et sted i
English: • Gently squeeze skin around cleaned injection site and hold firmly.
Danish: • Pres forsigtigt huden sammen rundt om det rensede injektionssted, og hold godt fast.
English: Cyltezo may have a minor influence on your ability to drive, cycle or use machines.
Danish: Cyltezo kan påvirke din evne i mindre grad til at føre motorkøretøj, cykle eller betjene maskiner.
English: Kaplan-Meier Curves Summarizing Time to Treatment Failure on or after Week 6 (Study UV I) or Week 2 (Study UV II)
Danish: Kaplan-Meier- kurver opsummerer tid til behandlingssvigt i eller efter uge 6 (Studie UV I) eller uge 2 (Studie UV II)
English: See leaflet for further information.
Danish: Læs indlægssedlen for at få yderligere information.
English: Adalimumabcan be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Danish: Adalimumab kan gives som monoterapi i tilfælde af intolerance over for methotrexat, eller hvis fortsat behandling med methotrexat er uhensigtmæssig (for virkning ved monoterapi, se pkt 5.1).