FrancophonIA/ELRC3.0 huggingface dataset:
English: After influenza vaccination, 73 of 119 abatacept-treated patients without protective antibody levels at baseline were able to mount an adequate immune response of at least a 4-fold increase in antibody titers to trivalent influenza vaccine.
Danish: Efter influenzavaccinationen var 73 af de 119 patienter, der blev behandlet med abatacept og ikke havde beskyttende antistofniveauer ved baseline, i stand til at opbygge et tilstrækkeligt immunsrespons på trivalent influenzavaccine med mindst en 4-dobbelt stigning i antistoftitre.
English: ORENCIA subcutaneous (SC) may be initiated with or without an intravenous (IV) loading dose.
Danish: Subkutan (s.c.) behandling med ORENCIA kan indledes med eller uden en intravenøs (i.v.)
English: * n = 119 for Abatacept SC + MTX; n = 116 for MTX
Danish: * n = 119 for abatacept s.c. + MTX; n = 116 for MTX
English: Upon reinitiating therapy, there were no injection reactions and no other safety concerns in patients who were withdrawn from subcutaneous therapy for up to 3 months relative to those who remained on subcutaneous therapy, whether therapy was reintroduced with or without an intravenous loading dose.
Danish: Efter genoptagelse af behandlingen var der ingen reaktioner på injektionsstedet og ingen andre sikkerhedsproblemer hos patienter, som havde seponeret den subkutane behandling i op til 3 måneder sammenlignet med de patienter, som fortsatte den subkutane behandling, uanset om behandlingen blev genoptaget med eller uden en intravenøs initialdosis.
English: Abatacept has been shown to be present in rat milk.
Danish: Abatacept er vist at blive udskilt i rottemælk.
English: the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate.
Danish: behandling af højaktiv og progressiv sygdom hos voksne patienter med reumatoid artritis, som ikke tidligere har været behandlet med methotrexat.
English: b Concurrent DMARDs included one or more of the following: methotrexate, chloroquine/hydroxychloroquine, sulfasalazine,
Danish: b Samtidig DMARD dækker en eller flere af følgende: methotrexat, chloroquin/hydroxychloroquin, sulfasalazin, leflunomid,
English: Serious adverse reactions were reported in 3.5% (11/318) and 6.1% (20/328) of the respective group.
Danish: Der blev rapporteret om alvorlige bivirkninger hos 3,5% (11/318) og 6,1% (20/328) i de respektive grupper.
English: The total content of the pre-filled syringe should be administered as a subcutaneous injection only.
Danish: Det totale indhold i den fyldte injektionssprøjte bør udelukkende administreres som subkutan injektion.
English: Don't shake the syringe, as this may damage the ORENCIA medicine.
Danish: ryste sprøjten, da det kan beskadige medicinen.
English: ORENCIA is used to treat moderate to severe active rheumatoid arthritis when you do not respond well enough to treatment with other disease-modifying medicines or with another group of medicines called 'tumour necrosis factor (TNF) blockers'.
Danish: ORENCIA anvendes til at behandle moderat til svær leddegigt, når du ikke reagerer godt nok på behandling med anden sygdomsmodificerende medicin eller med en gruppe lægemidler, der kaldes ”tumornekrosefaktor (TNF)-hæmmere”.
English: Step 3: Check the Dose on the Pre-filled Syringe Hold the syringe at eye level.
Danish: TRIN 3: Kontroller dosis på den fyldte injektionssprøjte Hold sprøjten i øjenhøjde.
English: The open label period of the study provided an assessment of the ability of abatacept to maintain efficacy for subjects originally randomised to abatacept and the efficacy response of those subjects who were switched to abatacept following treatment with infliximab.
Danish: Den åbne periode af studiet gav en vurdering af abatacepts muligheder for at opretholde effekt hos forsøgspersoner, som oprindeligt var randomiseret til abatacept, samt effektrespons hos de forsøgspersoner, der blev skiftet til abatacept efter behandling med infliximab.
English: Abatacept selectively modulates a key costimulatory signal required for full activation of T lymphocytes expressing CD28.
Danish: Abatacept modulerer selektivt et primært co-stimulerende signal, der er nødvendigt for fuld aktivering af de T-lymfocytter, hvor CD28-receptoren er til stede.
English: The most frequently reported autoimmune-related disorders other than the indication being studied during the cumulative period were psoriasis, rheumatoid nodule, and Sjogren's syndrome.
Danish: De hyppigst rapporterede autoimmune lidelser udover den indikation, der blev undersøgt i den samlede periode var psoriasis, gigtknuder og Sjögrens syndrom.
English: Mean steady-state trough concentrations were approximately 25 mcg/mL, and mean Cmax concentrations were approximately 290 mcg/mL.
Danish: De gennemsnitlige dalkoncentrationer ved steady-state var ca. 25 μg/ml, og de gennemsnitlige Cmax-koncentrationer var ca. 290 μg/ml.
English: The geometric mean estimate (90% confidence interval) for the bioavailability of abatacept following subcutaneous administration relative to intravenous administration is 78.6% (64.7%, 95.6%).
Danish: Det estimerede geometriske gennemsnit (90% konfidensinterval) for abatacepts biotilgængelighed efter subkutan administration var 78,6% (64,7%, 95,6%)sammenlignet med intravenøs administration.
English: B. Keep a record of your injection
Danish: B. Noter din indsprøjtning
English: Clinical responses were maintained or continued to improve up to one year in studies PsA-I and PsA-II.
Danish: Klinisk respons blev opretholdt eller forbedret i op til et år i studierne PsA-I og PsA-II.
English: After pneumococcal vaccination, 62 of 112 abatacept-treated patients were able to mount an adequate immune response of at least a 2-fold increase in antibody titers to pneumococcal polysaccharide vaccine.
Danish: Efter pneumokokvaccination var 62 af de 112 patienter, der blev behandlet med abatacept, i stand til at opbygge et tilstrækkeligt immunsrespons på pneumokok-polysaccharid-vaccine med mindst en fordobling i antistoftitre.
English: DO NOT PULL back the plunger at any time.
Danish: DU MÅ IKKE TRÆKKE stemplet tilbage på noget tidspunkt.
English: Studies in vitro and in animal models demonstrate that abatacept modulates T lymphocyte-dependent antibody responses and inflammation.
Danish: In vitro-studier og dyremodeller har vist, at abatacept modulerer det T-lymfocytafhængige antistofrespons og inflammation.
English: Let your ClickJect Pen warm up.
Danish: KLARGØR DIN CLICKJECT-PEN Lad din ClickJect-pen varme op.
English: Common adverse reactions: pyrexia Uncommon adverse reactions: haematuria, otitis (media and externa).
Danish: Almindelige bivirkninger: pyreksi Ikke almindelige bivirkninger: hæmaturi, otitis (media og externa).
English: ORENCIA contains sodium
Danish: ORENCIA indeholder natrium
English: Remove the ClickJect Pre-filled Pen from the injection site by lifting it straight up.
Danish: Fjern ClickJect-pennen fra injektionsstedet ved at løfte den lodret op.
English: leflunomide, azathioprine, gold, and anakinra.
Danish: azathioprin, guld og anakinra.
English: This medicinal product contains 34.5 mg sodium per maximum dose of 4 vials (8.625 mg sodium per vial), equivalent to 1.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 34,5 mg natrium per maksimal dosis af 4 hætteglas (8,625 mg natrium per hætteglas), svarende til 1,7% af den WHO anbefalede maximale daglige indtagelse af 2 g natrium for en voksen.
English: The overall frequency of injection site reactions was 2.6% (19/736) and 2.5% (18/721) for the subcutaneous abatacept group and the subcutaneous placebo group (intravenous abatacept), respectively.
Danish: Den samlede hyppighed af reaktioner på injektionsstedet var henholdsvis 2,6% (19/736) og 2,5% (18/721) for den subkutane abatacept-gruppe og den subkutane placebogruppe (intravenøst abatacept).
English: Always keep your Sharps container out of reach of children and animals.
Danish: Opbevar altid kanyleboksen utilgængeligt for børn og dyr.
English: Your doctor will advise you on the duration of treatment and what other medicines, including other disease-modifying medicines, if any, you may continue to take while on ORENCIA.
Danish: Lægen vil rådgive dig om, hvor længe du skal behandles og om, hvilken anden medicin, inklusive anden sygdomsdæmpende medicin, du kan fortsætte med, mens du er i behandling med ORENCIA.
English: The dose of abatacept was 500 mg for patients weighing less than 60 kg, 750 mg for patients weighing 60 to 100 kg, and 1,000 mg for patients weighing greater than 100 kg.
Danish: Abataceptdosis var 500 mg for patienter, der vejede mindre end 60 kg, 750 mg for patienter, der vejede 60-100 kg, og 1.000 mg for patienter, der vejede mere end 100 kg.
English: Among the patients who entered the open-label 12 month period, 59% (125/213) of patients receiving continuous abatacept plus methotrexate treatment and 48% (92/192) of patients who initially received methotrexate and switched to combination with abatacept had no progression.
Danish: Blandt de patienter, der blev inkluderet i den 12-måneders åbne periode, havde 59% (125/213) af de patienter, som kontinuerligt fik abatacept plus methotrexat-behandling og 48% (92/192) af de patienter, som oprindeligt fik methotrexat og skiftede til kombination med abatacept, ingen progression.
English: If you forget to use ORENCIA
Danish: Hvis du har glemt at bruge ORENCIA
English: The efficacy and safety of intravenous abatacept were assessed in randomised, double-blind, placebocontrolled clinical trials in adult patients with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria.
Danish: Effekt og sikkerhed af intravenøs abatacept er undersøgt i randomiserede, dobbeltblinde, placebokontrollerede kliniske studier med voksne patienter med aktiv reumatoid artritis diagnosticeret i overensstemmelse med ACR-kriterier (American College of Rheumatology).
English: AFTER THE INJECTION
Danish: EFTER INJEKTION
English: Hypersensitivity was reported uncommonly.
Danish: Hypersensitivitet blev rapporteret med hyppigheden ”ikke almindelig”.
English: Keep the pen refrigerated until ready to use.
Danish: Opbevar pennen i køleskab, indtil du skal anvende den.
English: Abatacept SC n = 116 Proportion of randomised patients with induction of remission after 12 months of treatment DAS28-Remissiona Odds Ratio (95% CI) vs. MTX P value
Danish: Abatacept s.c. n = 116 Andel af randomiserede patienter, hvor remission er induceret efter 12 måneders behandling DAS28-Remissiona Odds ratio (95% CI) versus MTX P-værdi
English: Combination with TNF-inhibitors
Danish: Kombination med TNF-hæmmere
English: Injection sites should be rotated and injections should never be given into areas where the skin is tender, bruised, red, or hard.
Danish: Der bør skiftes mellem injektionsstederne, og injektioner bør aldrig gives i områder, hvor huden er øm, blodunderløben, rød eller hård.
English: If you forget to receive ORENCIA
Danish: Hvis du har glemt at få ORENCIA
English: The most frequently reported adverse reactions (≥ 5%) among abatacept-treated patients were headache, nausea, and upper respiratory tract infections (including sinusitis).
Danish: De hyppigst indberettede bivirkninger (≥ 5%) blandt abatacept-behandlede patienter var hovedpine, kvalme og infektioner i de øvre luftveje (herunder sinusitis).
English: ORENCIA should not be infused concomitantly in the same intravenous line with other medicinal products.
Danish: ORENCIA må ikke infunderes samtidig eller i samme intravenøse slange som andre lægemidler.
English: Contact your doctor, nurse, or pharmacist for further instructions.
Danish: Kontakt lægen, sundhedspersonalet eller apotekspersonalet for yderligere oplysninger.
English: ORENCIA is used to treat psoriatic arthritis alone or in combination with methotrexate.
Danish: ORENCIA anvendes til at behandle psoriasisgigt alene eller i kombination med methotrexat.
English: Population pharmacokinetic analysis of abatacept serum concentration data from patients with pJIA 6 to 17 years of age following administration of intravenous abatacept 10 mg/kg revealed that the estimated clearance of abatacept, when normalised for baseline body weight, was higher in pJIA patients (0.4 mL/h/kg for a child weighing 40 kg) versus adult rheumatoid arthritis patients.
Danish: En populationsfarmakokinetisk analyse af abatacepts serumkoncentration fra data fra patienter med pJIA i alderen 6-17 år viste, at efter administration af 10 mg/kg intravenøs abatacept var den estimerede clearance af abatacept, normaliseret til baseline kropsvægt, højere hos pJIA-patienter (0,4 ml/t/kg for et barn med en vægt på 40 kg) i forhold til voksne patienter med reumatoid artritis.
English: Pre-filled syringe with UltraSafe Passive Needle guard
Danish: Fyldt injektionssprøjte med UltraSafe passiv beskyttelseshætte
English: Start of ORENCIA Treatment:
Danish: Start på ORENCIA-behandling:
English: Studies I, II, III, IV, V, VI, SC-II, and SC-III evaluated 339, 638, 389, 1441, 431, 509, 646, and 351 adult patients, respectively.
Danish: Studie I, II, III, IV, V, VI, SC-II og SC-III evaluerede henholdsvis 339, 638, 389, 1.441, 431, 509, 646 og 351 voksne patienter.
English: 10 kg to less than 25 kg
Danish: 10 kg til mindre end 25 kg
English: During the first 4-month treatment period of intravenous and subcutaneous abatacept in 409 patients with pJIA, the most common adverse reactions were nasopharyngitis (3.7% patients) and upper respiratory tract infection (2.9% patients).
Danish: Under den første 4 måneders behandlingsperiode med intravenøs og subkutan abatacept hos 409 patienter med pJIA, var de mest almindelige bivirkninger nasofaryngit (3,7% af patienterne) og øvre luftvejsinfektion (2,9% af patienterne).
English: In carcinogenicity studies in mice, an increase in lymphomas and mammary tumours were noted.
Danish: I carcinogenicitetsstudier med mus viste en stigning i lymfomer og mammatumorer.
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis or pJIA.
Danish: Behandling skal initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af reumatoid artritis eller pJIA.
English: This medicine has been prescribed for you only.
Danish: Lægen har ordineret dette lægemiddel dig personligt.
English: If this happens, contact immediately your doctor who will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.
Danish: Hvis dette sker, skal du straks kontakte lægen, som vil undersøge dig for tegn og symptomer på bivirkninger og om nødvendigt behandle dig for eventuelle symptomer.
English: It is important that you tell your baby's doctors and other health care professionals about your ORENCIA use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).
Danish: Det er vigtigt, at du fortæller barnets læge og andet sundhedspersonale om din behandling med ORENCIA under graviditeten, inden din baby bliver vaccineret (se også afsnittet om vaccination).
English: Improvement from baseline as measured by HAQ-DI at 24 months and over time was also similar between abatacept SC and adalimumab SC.
Danish: Forbedring i forhold til baseline målt ved HAQ-DI ved 24 måneder og over tid var også sammenlignelige mellem abatacept s.c. og adalimumab s.c.
English: Unless they had discontinued due to safety reasons, all patients who completed, or had a flare during Period B or were non-responders in Period A were offered entry into Period C, the open-label extension, which assessed long-term safety and efficacy.
Danish: Medmindre de afbrød behandlingen af sikkerhedsmæssig årsager, blev alle de patienter, som fuldførte behandlingen, fik opblussen af sygdommen i periode B eller ikke responderede på behandlingen i periode A, tilbudt at deltage i periode C, den åbne forlængelse, som vurderede sikkerhed og virkning ved langtidsbehandling.
English: ORENCIA should NOT be used with siliconised syringes (see section 6.6).
Danish: ORENCIA må ikke anvendes med silikonebehandlede sprøjter (se pkt.
English: No dose adjustment is required when used in combination with other DMARDs, corticosteroids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics.
Danish: Dosisjustering er ikke nødvendig ved samtidig behandling med andre DMARDs, kortikosteroider, salicylater, non-steroide anti-inflammatoriske lægemidler (NSAID) eller analgetika.
English: To minimise foam formation in solutions of ORENCIA the vial should be rotated with gentle swirling until the contents are completely dissolved.
Danish: For at minimere skumdannelse i ORENCIAinfusionsvæsken, vendes hætteglasset med forsigtige, roterende bevægelser, indtil indholdet er fuldstændig opløst.
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. In study SC-I, improvement from baseline as measured by HAQ-DI at 6 months and over time was similar between subcutaneous and intravenous administration.
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. I studie SC-I var forbedring fra baseline målt ved HAQ-DI ved måned 6 og over tid den samme ved subkutan og intravenøs administration.
English: The primary outcome was the mean change in disease activity in abatacept-treated patients compared to placebo-treated patients at 6 months with a subsequent double-blind assessment of safety and efficacy of abatacept and infliximab at 12 months.
Danish: Det primære endepunkt var gennemsnitlig ændring i sygdomsaktivitet hos abatacept-behandlede patienter sammenlignet med placebobehandlede ved 6 måneder med en efterfølgende dobbeltblind vurdering af sikkerhed og effekt af abatacept og infliximab ved 12 måneder.
English: Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis.
Danish: Behandling skal initieres og superviseres af speciallæger med erfaring i diagnosticering og behandling af reumatoid artritis.
English: The risk of disease flare for patients continuing on abatacept was less than one third that for placebo-treated patients (hazard ratio estimate=0.31; 95% CI
Danish: Risikoen for opblussen af sygdom hos patienter i fortsat behandling med abatacept var mindre end en tredjedel af risikoen for placebo-behandlede patienter (estimeret hazard ratio=0,31; 95% CI 0,16;
English: Abatacept is a fusion protein produced by recombinant DNA technology in Chinese hamster ovary cells.
Danish: Abatacept er et fusionsprotein fremstillet ved rekombinant DNA-teknologi i ovarieceller fra kinesiske hamstre.
English: At 12 months 61% (148/242) of the patients treated with abatacept plus methotrexate and 53% (128/242) of the patients treated with methotrexate plus placebo had no progression (TSS ≤ 0).
Danish: Efter 12 måneder udviste 61% (148/242) af patienterne behandlet med abatacept plus methotrexat og 53% (128/242) af patienterne behandlet med methotrexat plus placebo ingen progression (TSS ≤ 0).
English: Healthcare professionals will monitor you while you receive your ORENCIA infusion.
Danish: Sundhedspersonalet holder øje med dig under ORENCIA-infusionen.
English: Study II, III, IV, and VI patients were randomised to receive a fixed dose approximating 10 mg/kg of abatacept or placebo for 12 (studies II, IV, and VI) or 6 months (study III).
Danish: Patienterne i studie II, III IV og VI randomiseredes til fast dosis abatacept, ca. 10 mg/kg, eller placebo i 12 (studie II, IV og VI) eller 6 måneder (studie III).
English: Abatacept is not recommended for use in combination with TNF-inhibitors.
Danish: Abatacept bør ikke bruges i kombination med TNF-hæmmere.
English: Pull orange needle cover STRAIGHT off.
Danish: Træk den orange kanylehætte LIGE af.
English: Study SC-I compared the safety of abatacept including injection site reactions following subcutaneous or intravenous administration.
Danish: Studie SC-I sammenlignede abatacepts sikkerhed inklusive reaktioner på injektionsstedet efter subkutan og intravenøs administration.
English: Abatacept 125 mg SC N=213
Danish: Abatacept 125 mg s.c. N=213
English: Abatacept has been studied in patients with pJIA in two clinical trials (pJIA SC study and pJIA IV study).
Danish: Abatacept er blevet undersøgt hos patienter med pJIA i to kliniske studier (pJIA s.c.-studiet og pJIA IV-studiet).
English: The effects of ORENCIA in pregnancy are not known, so do not use ORENCIA if you are pregnant unless your doctor specifically recommends it.
Danish: Effekten af ORENCIA på graviditet kendes ikke, så du må ikke anvende ORENCIA, hvis du er gravid, medmindre lægen specifikt anbefaler det.
English: If you are already on intravenous ORENCIA treatment and wish to transition to ORENCIA subcutaneous, you should receive a subcutaneous injection instead of your next intravenous infusion, followed by weekly subcutaneous injections of ORENCIA.
Danish: Hvis du allerede får ORENCIA intravenøst og ønsker at skifte til subkutan behandling, skal du have en subkutan indsprøjtning i stedet for den næste intravenøse infusion, efterfulgt af en ugentlig subkutan injektion af ORENCIA.
English: During Period B, the time to disease flare for the patients randomised to placebo was significantly shorter than for those randomised to abatacept (primary endpoint, p=0.0002; log-rank test).
Danish: I periode B var tiden til opblussen af sygdom for de patienter, der var randomiseret til placebo, signifikant kortere end for de patienter, der var randomiseret til abatacept (primært endepunkt, p=0,0002; log-rank test).
English: Store unused syringes in the refrigerator in the original carton.
Danish: opbevare ubrugte injektionssprøjter i køleskabet i den originale æske.
English: Of the 190 patients enrolled, 170 completed Period A, 65% (123/190) achieved an ACR Pedi 30 response, and 122 were randomised to Period B. Responses were similar in all subtypes of pJIA studied and for patients with or without methotrexate use.
Danish: Af de 190 deltagende patienter, gennemførte 170 periode A, 65% (123/190) opnåede et ACR Pedi 30respons, og 122 blev randomiseret til periode B. Respons var ens for alle undersøgte suptyper af pJIA og for patienter med eller uden brug af methotrexat.
English: The safety and efficacy of ORENCIA in children below 2 years of age have not been established.
Danish: Sikkerhed og virkning af ORENCIA hos børn under 2 år er ikke klarlagt.
English: The patients entered in the trial were a mean of 12.4 years of age with mean disease duration of 4.4 years.
Danish: De patienter, der deltog i studiet, var i gennemsnit 12,4 år med en gennemsnitlig sygdomsvarighed på 4,4 år.
English: Serious infections, including sepsis and pneumonia, have been reported with abatacept (see section 4.8).
Danish: Der er rapporteret alvorlige infektioner, herunder sepsis og pneumoni med abatacept (se pkt.
English: 125 mg/mL orange plunger
Danish: 125 mg/ml orange stempel
English: Response rates at the end of Period A, at the end of Period B and after 5 years exposure in Period C are summarized in Table 10:
Danish: Responsraterne i slutningen af periode A, i slutningen af periode B og efter 5 års eksponering i periode C er opsummeret i Tabel 10.
English: The overall safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis (Table 2).
Danish: Den samlede sikkerhedsprofil var sammenlignelig mellem PsA-I og PsA-II studierne og i overensstemmelse med sikkerhedsprofilen ved reumatoid artritis (Tabel 2).
English: The overall safety profile was comparable between studies PsA-I and PsA-II and consistent with the safety profile in rheumatoid arthritis (Table 1).
Danish: Den samlede sikkerhedsprofil var sammenlignelig mellem PsA-I og PsA-II studierne og i overensstemmelse med sikkerhedsprofilen ved reumatoid artritis (Tabel 1).