FrancophonIA/ELRC3.0 huggingface dataset:
English: Greater improvements were seen with abatacept than with placebo in other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Danish: Der er set større forbedringer med abatacept end med placebo i andre målinger af sygdomsaktivitet af reumatoid artritis, som ikke er inkluderede i ACR-responskriterierne fx morgenstivhed.
English: No significant changes in PASI scores with abatacept treatment were seen over the 24-week doubleblind period.
Danish: Der blev ikke observeret signifikant ændring i PASI-scores med abatacept-behandling under den 24ugers dobbelt-blindede periode.
English: Medicinal products which affect the immune system, including ORENCIA, may affect host defences against infections and malignancies, and affect vaccination responses.
Danish: Lægemidler som påvirker immunsystemet, inklusive ORENCIA, kan påvirke forsvaret mod infektioner og maligniteter samt påvirke vaccinationsrespons.
English: Table 1: Weekly dose of ORENCIA Body weight of patient
Danish: Tabel 1: Ugentlig dosis af ORENCIA Patientens kropsvægt
English: In study II, the baseline median TSS was 31.7 in abatacept-treated patients and 33.4 in placebo-treated patients.
Danish: I studie II var middel-TSS ved baseline 31,7 hos de abatacept-behandlede patienter og 33,4 hos de placebobehandlede patienter.
English: It is not known whether ORENCIA passes into human milk.
Danish: Det vides ikke, om ORENCIA udskilles i mælk hos mennesker.
English: The progression of structural damage was lower in patients receiving continuous abatacept plus methotrexate treatment (for 24 months) compared to patients who initially received methotrexate plus placebo (for 12 months) and were switched to abatacept plus methotrexate for the next 12 months.
Danish: Progression af strukturel skade var lavere hos patienter, der kontinuerligt fik abatacept plus methotrexat-behandling (i 24 måneder), sammenlignet med patienter, der oprindeligt fik methotrexat plus placebo (i 12 måneder), og som blev skiftet til abatacept plus methotrexat i de næste 12 måneder.
English: Doses up to 50 mg/kg have been administered without apparent toxic effect.
Danish: Der er administreret doser på op til 50 mg/kg uden åbenlys toksisk effekt.
English: Uncommon (may affect up to 1 in 100 people): blood in urine ear infection
Danish: Ikke almindelige (kan påvirke op til 1 ud af 100 personer): blod i urinen øreinfektion
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til subkutan anvendelse.
English: In the substudy 108 subjects were randomised 1:1 in double blinded fashion to receive abatacept at doses approximating 10 mg/kg (ABA 10) or 5 mg/kg (ABA 5).
Danish: I substudiet blev 108 personer randomiseret 1:1 på dobbeltblind vis til at få abatacept i doser på ca. 10 mg/kg (ABA 10) eller 5 mg/kg (ABA 5).
English: B. Position the syringe and inject ORENCIA Hold the syringe by its body in one hand between your thumb and index finger (Figure 5).
Danish: B. Placer injektionssprøjten og indsprøjt ORENCIA Hold cylinderen mellem tommelfinger og pegefinger med den ene hånd (Figur 5).
English: STEP 2: Choose and prepare your injection site
Danish: TRIN 2: Vælg og klargør et injektionssted
English: Uncommon Palpitations, tachycardia, bradycardia
Danish: Palpitationer, takykardi, bradykardi
English: During the first 4-month open-label period, the overall safety profile in these 409 pJIA patients was similar to that observed in the RA population with the following exceptions in the pJIA patients:
Danish: Under den første 4 måneders åbne periode svarede den overordnede sikkerhedsprofil for de 409 pJIA patienter til den, der var observeret hos RA-populationen, med de følgende undtagelser hos pJIA-patienterne:
English: Overall, there was no apparent correlation of antibody development to clinical response or adverse events.
Danish: Generelt sås ingen umiddelbar korrelation mellem udvikling af antistoffer og klinisk respons eller bivirkninger.
English: The safety observed in the treatment arm that reinitiated therapy without an intravenous loading dose was also consistent with that observed in the other studies.
Danish: Sikkerheden i behandlingsarmen, som indledte behandling uden en intravenøs initialdosis, svarede også til sikkerheden i de andre studier.
English: See the Package Leaflet for additional disposal information.
Danish: Se indlægssedlen for flere oplysninger vedrørende bortskaffelse.
English: Allow the syringe to rest at room temperature for 30 to 60 minutes before you inject.
Danish: Lad injektionssprøjten ligge ved stuetemperatur i 30-60 minutter, før du indsprøjter væsken.
English: The safety and efficacy of subcutaneous abatacept were assessed in a single-arm, open-label study designed with a primary endpoint of steady-state trough concentration (cmin) at 4 months (short-term period) in the 6 to 17 year age cohort.
Danish: Sikkerhed og virkning af subkutan abatacept blev undersøgt i et enkeltarmet, åbent studie designet med steady state dalkoncentration (Cmin) som primært endepunkt ved 4 måneder (kortvarig periode) i aldersgruppen 6-17 år.
English: Pinch the skin
Danish: Klem huden
English: The pharmacokinetics of abatacept is similar in adult RA and paediatric pJIA patients except for the higher SC absorption in pJIA patients.
Danish: Farmakokinetikken af abatacept er ens for voksne RA og pædiatriske pJIA patienter med undtagelse af den højere s.c. absorption hos pJIA patienter.
English: Each week you can use the same area of your body, but use a different injection site in that area.
Danish: Du kan bruge samme område hver uge, men du skal bruge et andet injektionssted inden for området.
English: Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin.
Danish: Psoriasisgigt er en inflammatorisk sygdom i leddene, som oftest ledsages af psoriasis, en inflammatorisk sygdom i huden.
English: ORENCIA is intended for use under the guidance of a healthcare professional.
Danish: ORENCIA bør anvendes under vejledning fra uddannet sundhedspersonale.
English: Release Needle Guard: slowly lift your thumb from the plunger to activate the needle guard.
Danish: Udløs beskyttelseshætte: løft din tommelfinger langsomt fra stemplet for at aktivere beskyttelseshætten.
English: There may be a small air bubble in the liquid in the syringe.
Danish: Der kan godt være en lille luftboble i væsken i injektionssprøjten.
English: In those patients who initially received infliximab and then switched to abatacept, the reduction in the mean DAS28 score from baseline was 3.29 at day 729 and 2.48 at day 365.
Danish: Hos de patienter, der oprindeligt fik infliximab og derefter skiftede til abatacept, var reduktionen i den gennemsnitlige DAS28-score fra baseline 3,29 på dag 729 og 2,48 på dag 365.
English: Don't speed the warming process in any way, such as using the microwave or placing the syringe in warm water.
Danish: Du må ikke på nogen måde forsøge at fremskynde processen ved f.eks. at varme den i en mikroovn eller i varmt vand.
English: Pharmacokinetics of abatacept for subcutaneous injection have been studied in patients 2 to 17 years of age.
Danish: Abatacepts farmakokinetik for subkutan injektion, har været undersøgt hos patienter i alderen 2-17 år.
English: Parenteral medicinal products containing maltose can interfere with the readings of blood glucose monitors that use test strips with glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ).
Danish: Parenterale lægemidler, der indeholder maltose kan påvirke aflæsningen i blod-glucoseapparater, der anvender strips med glucosedehydrogenasepyrroloquinolinequinon (GDH-PQQ).
English: ORENCIA should not be used in pregnant women unless clearly necessary.
Danish: ORENCIA må ikke gives til gravide kvinder, medmindre det er tvingende nødvendigt.
English: Inadequate response to TNF Inhibitor
Danish: Utilstrækkeligt respons på TNF-hæmmer
English: MARKETING AUTHORISATION NUMBERS EU/1/07/389/011-012
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/07/389/011-012
English: At the start, your doctor or nurse may inject ORENCIA.
Danish: I begyndelsen vil det muligvis være din læge eller en sygeplejerske, der giver dig ORENCIA.
English: * No active joints, physician's global assessment of disease severity ≤10 mm and CRP ≤0.6 mg/dL.
Danish: Inaktiv sygdom* * Ingen aktive led, lægens globale vurdering af sygdomsalvorlighed ≤10 mm og CRP≤0,6 mg/dl.
English: The results from studies II, III, and VI are shown in Table 7.
Danish: Resultater fra studie II, III og VI angives i Tabel 7.
English: In study II, 43% of the patients who had not achieved an ACR 20 response at 6 months developed an ACR 20 response at 12 months.
Danish: I studie II udviklede 43% af de patienter, som ikke opnåede et ACR 20-respons efter 6 måneder, ACR 20respons efter 12 måneder.
English: Exploratory studies to assess the effect of abatacept on the antibody response to vaccination in healthy subjects as well as the antibody response to influenza and pneumococcal vaccines in rheumatoid arthritis patients suggested that abatacept may blunt the effectiveness of the immune response, but did not significantly inhibit the ability to develop a clinically significant or positive immune response.
Danish: Eksplorative studier med henblik på at vurdere abatacepts effekt på antistofresponset efter vaccination af raske forsøgspersoner såvel som på antistofresponset på influenzavaccine og pneumokokvaccine hos patienter med reumatoid artritis tyder på, at abatacept kan svække effekten af immunresponset, men ikke i signifikant grad hæmme evnen til at udvikle klinisk signifikant eller positivt immunrespons.
English: The efficacy and safety of abatacept were assessed in two randomised, double-blind, placebocontrolled trials (studies PsA-I and PsA-II) in adult patients, age 18 years and older.
Danish: Effekt og sikkerhed af abatacept er undersøgt i to randomiserede, dobbelt-blindede, placebokontrollerede kliniske studier (studierne PsA-I og PsA-II) med voksne patienter i alderen 18 år og ældre.
English: In abatacept-treated patients in studies II and III, statistically significant improvement in the ACR 20 response versus placebo was observed after administration of the first dose (day 15), and this improvement remained significant for the duration of the studies.
Danish: Hos abatacept-behandlede patienter i studie II og III sås en statistisk signifikant forbedring i ACR 20respons versus placebo efter administration af første dosis (dag 15), og denne forbedring forblev signifikant igennem hele studiet.
English: Juvenile rats seemed to be more sensitive to lymphocytic inflammation of thyroid.
Danish: Unge rotter virkede mere følsomme over for lymfocyt-inflammation i skjoldbruskkirtlen.
English: No major safety issues were identified with use of abatacept in combination with sulfasalazine, hydroxychloroquine, or leflunomide.
Danish: Der er ikke identificeret øget risiko for bivirkninger i forbindelse med brug af abatacept i kombination med sulfasalazin, hydroxychloroquin eller leflunomid.
English: • Please make sure you also have a list of all your other medicines with you at any visit to a health care professional.
Danish: • Du skal medbringe en liste over alle de lægemidler, som du anvender, når du går til lægen eller konsulterer andet sundhedspersonale.
English: After multiple intravenous infusions (days 1, 15, 30, and every 4 weeks thereafter), the pharmacokinetics of abatacept in rheumatoid arthritis patients showed dose-proportional increases of Cmax and AUC over the dose range of 2 mg/kg to 10 mg/kg.
Danish: Efter gentagne intravenøse infusioner (dag 1, 15, 30 og herefter hver 4. uge) har farmakokinetik for abatacept hos patienter med reumatoid artritis vist dosisproportionelle stigninger i Cmax og AUC over dosisområdet 2 mg/kg til 10 mg/kg.
English: • See the ORENCIA package leaflet for more information.
Danish: • Se yderligere information i indlægssedlen for ORENCIA.
English: Do not freeze.
Danish: DEN MÅ IKKE NEDFRYSES.
English: Based on its mechanism of action, abatacept is expected to have no or negligible influence on the ability to drive and use machines.
Danish: Baseret på virkningsmekanismen påvirker abatacept ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: When the intravenous loading dose was not administered, a mean trough concentration of 12.6 mcg/mL was achieved after 2 weeks of dosing.
Danish: Når der ikke blev administreret en intravenøs initialdosis, blev en gennemsnitlig dalkoncentration på 12,6 mikrog/ml nået efter 2 ugers dosering.
English: The results from studies II, III, and VI are shown in Table 6.
Danish: Resultater fra studie II, III og VI angives i Tabel 6.
English: If a response to abatacept is not present within 6 months of treatment, the continuation of the treatment should be reconsidered (see section 5.1).
Danish: Hvis der ikke ses respons på abataceptbehandling inden for 6 måneder, skal det overvejes, om behandlingen skal fortsætte (se pkt.
English: The entire, fully diluted ORENCIA solution should be administered over a period of 30 minutes and must be administered with an infusion set and a sterile, non-pyrogenic, low-protein-binding filter (pore size of 0.2 to 1.2 μm).
Danish: Hele den fortyndede ORENCIA-infusionsvæske indgives over en periode på 30 minutter og skal administreres med et infusionssæt og et sterilt, ikke-pyrogent filter med lav proteinbindingsgrad (porestørrelse 0,2 - 1,2 μm).
English: Of the 219 patients with pJIA treated with subcutaneous abatacept during the first 4-month abatacept treatment, the frequency of local injection reactions was 4.6% (10/219); injection site pain and injection site erythema were the most frequently reported local injection reactions.
Danish: Af de 219 patienter med pJIA, der blev behandlet med subkutan abatacept under de første 4 måneders behandling med abatacept, var frekvensen af lokale injektionsreaktioner 4,6% (10/219); smerter og erytem på injektionsstedet var de hyppigst indrapporterede lokale injektionsreaktioner.
English: In the 6 to 17 year age cohort 132 (76.3%) patients completed 2 years.
Danish: I aldersgruppen 6-17 år gennemførte 132 (76,3%) patienter 2 år.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Danish: I tilfælde af overdosis anbefales det at overvåge patienten for eventuelle tegn og symptomer på bivirkninger og at klargøre relevant symptomatisk behandling.
English: Serious infections were reported in 0.8% (1/119), 3.4% (4/116) and 0% (0/116) patients.
Danish: Alvorlige infektioner blev rapporteret hos 0,8% (1/119), 3,4% (4/116) og 0% (0/116) af patienterne.
English: - You should be screened for certain infections prior to treatment with ORENCIA.
Danish: - Du bør undersøges for bestemte infektioner, inden du begynder behandling med ORENCIA.
English: The reduction from baseline in mean DAS28 score at day 365 (3.06) was maintained through day 729 (-3.34) in those patients who continued with abatacept.
Danish: Reduktionen i den gennemsnitlige DAS28-score fra baseline på dag 365 (-3,06) blev opretholdt til dag 729 (-3,34) hos de patienter, der fortsatte med abatacept.
English: Treatment with immunosuppressive therapy, such as ORENCIA, may be associated with progressive multifocal leukoencephalopathy (PML).
Danish: Immunsuppressiv behandling kan være forbundet med progressiv multifokal leukoencefalopati (PML).
English: Dates of ORENCIA Treatment:
Danish: Datoer for ORENCIA-behandling:
English: Study IV primarily assessed safety in patients with active rheumatoid arthritis requiring additional intervention in spite of current therapy with non-biological and/or biological DMARDs; all DMARDs used at enrollment were continued.
Danish: Studie IV vurderede primært sikkerhed hos patienter med aktiv reumatoid artritis med behov for yderligere intervention på trods af aktuel behandling med non-biologisk og/eller biologisk DMARD; alle DMARDs anvendt ved inklusion blev fortsat.
English: Improvement in physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) in studies II, III, IV, V, and VI and the modified HAQ-DI in study I. The results from studies II, III, and VI are shown in Table 7.
Danish: Forbedring i fysisk funktion blev målt ved HAQ-DI (Health Assessment Questionnaire Disability Index) i studie II, III, IV, V og VI samt et modificeret HAQ-DI i studie I. Resultater fra studie II, III og VI angives i Tabel 7.
English: The types of infections were consistent with those commonly seen in outpatient paediatric populations.
Danish: Infektionstyperne var i overensstemmelse med de infektionstyper, der almindeligvis ses hos ambulante pædiatriske patienter.
English: It is important that you tell your baby's doctors and other health care professionals about your ORENCIA use during your pregnancy so they can decide when your baby should receive any vaccine.
Danish: Det er vigtigt, at du fortæller barnets læge og andet sundhedspersonale om din behandling med ORENCIA under graviditeten, så de kan afgøre, hvornår din baby skal vaccineres.
English: Polyarticular juvenile idiopathic arthritis is a long-term inflammatory disease affecting one or more joints in children and adolescents.
Danish: Børnegigt (polyartikulær juvenil idiopatisk artritis) Børnegigt er en længerevarende inflammatorisk sygdom, der påvirker et eller flere led hos børn og unge.
English: What you need to know before you use ORENCIA 3.
Danish: Det skal du vide, før du begynder at bruge ORENCIA 3.
English: Consistent with previous experience, titers and persistence of antibody responses were generally low and did not increase upon continued dosing (6.8% subjects were seropositive on 2 consecutive visits), and there was no apparent correlation of antibody development to clinical response, adverse events, or pharmacokinetics.
Danish: I overensstemmelse med tidligere erfaringer var titre og persistens af antistofrespons generelt lave og forøgedes ikke ved forsat behandling (6,8% af forsøgspersonerne var seropositive ved 2 på hinanden følgende kontrolbesøg), og der var ingen åbenlys sammenhæng mellem udvikling af antistoffer og klinisk respons, bivirkninger eller farmakokinetik.
English: Antibodies directed against the abatacept molecule were assessed by ELISA assays in 3,985 rheumatoid arthritis patients treated for up to 8 years with abatacept.
Danish: Antistoffer rettet mod abataceptmolekylet blev vurderet ved ELISA-analyse hos 3.985 patienter med reumatoid artritis, der blev behandlet med abatacept i op til 8 år.
English: For ITT; n=736, 721 for subcutaneous (SC) and intravenous (IV) abatacept,
Danish: For ITT; henholdsvis n=736, 721 for subkutan (s.c).
English: Dose selection: see section 3 ‘How to use ORENCIA' of the Package Leaflet
Danish: Fastsættelse af dosis: Se afsnit 3 ”Sådan skal du bruge ORENCIA” på indlægssedlen.
English: Press a cotton ball over the injection site and hold for 10 seconds.
Danish: Pres en vatrondel på injektionsstedet i 10 sekunder.
English: Examine the ClickJect Pre-filled Pen:
Danish: Undersøg den fyldte ClickJect-pen:
English: The rate of progression of structural damage in year 2 was significantly lower than that in year 1 for patients randomised to abatacept (p < 0.0001).
Danish: Progressionshastigheden af strukturel skade var signifikant mindre det andet år sammenlignet med det første år hos patienter, som var randomiseret til abatacept (p < 0,0001).
English: No evidence of lymphomas or preneoplastic morphological changes was observed, despite the presence of a virus, lymphocryptovirus, which is known to cause such lesions in immunosuppressed monkeys within the time frame of this study.
Danish: Inden for studiets tidsramme sås ingen tegn på lymfomer eller præ-neoplastiske morfologiske forandringer på trods af tilstedeværelse af et virus, lymfocryptovirus, som vides at forårsage sådanne læsioner hos immunsupprimerede aber.
English: D. Gather your additional supplies and keep them within easy reach.
Danish: D. Læg de ting, du skal bruge frem, og hold dem inden for rækkevidde.
English: ORENCIA can be given as monotherapy in case of intolerance to methotrexate or when treatment with methotrexate is inappropriate.
Danish: ORENCIA kan gives som monoterapi i tilfælde af intolerance overfor methotrexat eller når behandling med methotrexat er uhensigtsmæssig.
English: In study III the efficacy and safety of abatacept were assessed in patients with an inadequate response to a TNF-inhibitor, with the TNF-inhibitor discontinued prior to randomisation; other DMARDs were permitted.
Danish: Studie III vurderede effekt og sikkerhed af abatacept hos patienter med utilstrækkeligt respons på en TNFhæmmer, hvor TNF-hæmmeren seponeredes inden randomisering; andre DMARDs var tilladt.
English: Avoid any areas with scars or stretch marks.
Danish: Du skal undgå områder med ar eller strækmærker.
English: They had active disease, with a mean active joint count of 11.8, mean number of joints with loss of motion of 10.3, and a mean elevated C-reactive protein (CRP) level of 1.24 mg/dL at baseline.
Danish: De havde aktiv sygdom, med et gennemsnitligt antal aktive led på 11,8, gennemsnitligt antal led med tab af bevægelse på 10,3. og et gennemsnitligt forhøjet C-reaktivt protein (CRP) niveau på 1,24 mg/dl ved baseline.
English: Overall antibodies against abatacept were generally transient and of low titer.
Danish: Antistoffer mod abatacept var generelt forbigående og af lav titer.
English: Push DOWN on skin to unlock the Pen.
Danish: Tryk NED mod huden, så pennen låses op.
English: Outer area of upper arms
Danish: Ydre område af overarme
English: Weekly Dose of ORENCIA Body Weight of Patient
Danish: Ugentlig dosis af ORENCIA Patientens vægt
English: In study II, among patients with clinically meaningful improvement at month 12, 88% retained the response at month 18, and 85% retained the response at month 24.
Danish: I studie II opretholdt 88% af de patienter, der havde klinisk betydningsfuld forbedring ved måned 12, respons ved måned 18, og 85% opretholdt respons ved måned 24.
English: There were no adverse reactions that occurred at ≥ 2% in either treatment group during the 24-week placebocontrolled period.
Danish: Der var ingen bivirkninger, som forekom ≥ 2% i nogen af behandlingsgrupperne under den 24-ugers placebokontrollerede periode.
English: ORENCIA contains maltose, which is a type of sugar that can give falsely high blood glucose readings with certain types of blood glucose monitors.
Danish: ORENCIA indeholder maltose, som er en sukkertype, der kan give et falsk forhøjet blodsukkerresultat ved nogle typer apparater.
English: In study VI, which only included adults, a significantly higher proportion of patients in the abatacept plus methotrexate group (41%) achieved DAS28 (CRP)-defined remission (score < 2.6) versus the methotrexate plus placebo group (23%) at year 1.
Danish: I studie VI, som kun omfattede voksne, opnåede en væsentligt større andel af patienterne i abatacept plus methotrexat-gruppen (41%) DAS28 (CRP)-defineret remission (score < 2,6) versus methotrexat plus placebo-gruppen (23%) ved år 1.
English: Physicians should exercise caution when considering the use of ORENCIA in patients with a history of recurrent infections or underlying conditions which may predispose them to infections.
Danish: Lægen bør udvise forsigtighed, når ORENCIA anvendes til patienter med recidiverende infektioner eller underliggende tilstande, som kan disponere til infektioner i anamnesen.
English: There is insufficient evidence to assess the safety and efficacy of abatacept in combination with anakinra or rituximab (see section 4.4).
Danish: Der foreligger ikke tilstrækkelig dokumentation til vurdering af sikkerhed og effekt af abatacept i kombination med anakinra eller rituximab (se pkt.