FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been reports of non-melanoma skin cancers in patients receiving ORENCIA (see section 4.8).
Danish: Der er rapporteret om non-melanom hudcancer hos patienter, der får ORENCIA (se pkt.
English: ORENCIA will be given to you under the supervision of an experienced doctor.
Danish: Du vil blive behandlet med ORENCIA under opsyn af en speciallæge.
English: Studies I, II, III, IV, V, VI, SC-I, SC-II, and SC-III evaluated 339, 638, 389, 1441, 431, 509, 1371, 646, and 351 adult patients, respectively.
Danish: Studie I, II, III, IV, V, VI, SC-I, SC-II og SC-III evaluerede henholdsvis 339, 638, 389, 1.441, 431, 509, 1.371, 646 og 351 voksne patienter.
English: This medicine contains 34.5 mg sodium (main component of cooking/table salt) per maximum dose of 4 vials (8.625 mg sodium per vial).
Danish: Denne medicin indeholder 34,5 mg natrium (hovedkomponent i madlavnings-/bordsalt) per maksimumsdosis fra 4 hætteglas (8,625 mg natrium per hætteglas).
English: ORENCIA lessens the immune system's attack on normal tissues by interfering with the immune cells (called T lymphocytes) that contribute to the development of rheumatoid arthritis.
Danish: ORENCIA mindsker immunsystemets angreb på det normale væv ved at påvirke de immunceller (T-lymfocytter), som bidrager til udviklingen af leddegigt.
English: ORENCIA is available in the following presentations:
Danish: ORENCIA fås i følgende pakningsstørrelser:
English: if you have had tuberculosis (TB) or have symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever) tell your doctor.
Danish: hvis du har haft tuberkulose (TB), eller har symptomer på tuberkulose (vedvarende hoste, vægttab, mathed, let feber), skal du kontakte lægen.
English: The incidence rate in abatacept-treated patients was 3.8 per 100 person-years in the cumulative period.
Danish: Incidensraten hos abatacept-behandlede patienter var 3,8 pr. 100 personår i den samlede periode.
English: Record the date, time, and site where you inject.
Danish: Noter datoen, klokkeslættet og injektionsstedet.
English: ORENCIA is supplied as a powder for solution for infusion.
Danish: ORENCIA fås som et pulver til opløsning til infusionsvæske.
English: PUSH DOWN on skin
Danish: TRYK NED mod huden
English: Significantly more placebo recipients flared during Period B (33/62; 53%) than those maintained on abatacept (12/60; 20%; chi-square p<0.001).
Danish: Signifikant flere af placebo-patienterne fik opblussen af sygdom i periode B (33/62; 53%) i forhold til de patienter, der fortsat fik abatacept (12/60; 20%; chi-square P<0,001).
English: Complete drug withdrawal led to loss of remission (return to disease activity) in all three treatment arms (abatacept with methotrexate, abatacept or methotrexate alone) in a majority of patients (Table 3).
Danish: Komplet seponering af lægemidler medførte tab af remission (tilbagevenden til sygdomsaktivitet) i alle tre behandlingsarme (abatacept med methotrexat, abatacept og methotrexat alene) hos størstedelen af patienterne (Tabel 3).
English: Do not touch the injection site again before giving the injection.
Danish: Rør ikke dette område igen, før indsprøjtningen gives.
English: Improvement in HAQ-DI scores was maintained or improved for up to 1 year with continuing abatacept treatment in both PsA-I and PsA-II studies.
Danish: Forbedring af HAQ-DI score blev opretholdt eller forbedret i op til et år med fortsat behandling med abatacept i både PsA-I og PsA-II studierne.
English: Rheumatoid arthritis is a long-term progressive systemic disease that, if untreated, can lead to serious consequences, such as joint destruction, increased disability and impairment of daily activities.
Danish: Leddegigt er en langvarig progressiv (tiltagende) sygdom, der ubehandlet kan have alvorlige konsekvenser, såsom nedbrydning af led, øget funktionsnedsættelse og besværliggørelse af daglige aktiviteter.
English: Air Bubble
Danish: Luftboble
English: Complete drug withdrawal led to loss of remission (return to disease activity) in all three treatment arms (abatacept with methotrexate, abatacept or methotrexate alone) in a majority of patients (Table 4).
Danish: Komplet seponering af lægemidler medførte tab af remission (tilbagevenden til sygdomsaktivitet) i alle tre behandlingsarme (abatacept med methotrexat, abatacept og methotrexat alene) hos størstedelen af patienterne (Tabel 4).
English: While TNF-inhibitors did not influence abatacept clearance, in placebo-controlled clinical trials, patients receiving concomitant treatment with abatacept and TNF-inhibitors experienced more infections and serious infections than patients treated with only TNF-inhibitors.
Danish: Selvom TNF-hæmmere ikke påvirkede abatacepts clearance i placebo-kontrollerede studier, oplevede den patientgruppe, der fik samtidig behandling med abatacept og TNF-hæmmere, flere infektioner og alvorlige infektioner end de patienter, der fik behandling med TNF-hæmmere alene.
English: There is a theoretical concern that treatment with abatacept might increase the risk for autoimmune processes in adults and children, for example deterioration of multiple sclerosis.
Danish: Der er teoretiske overvejelser om, hvorvidt behandling med abatacept kan øge risikoen for autoimmune processer hos voksne og børn fx forværring af dissemineret sklerose.
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 9:
Danish: Responsraterne i slutningen af periode A, i slutningen af periode B og efter 5 års eksponering i periode C er opsummeret i Tabel 9.
English: Hold the body of the pre-filled syringe in your hand using your thumb and index finger.
Danish: Hold på cylinderen på den fyldte injektionssprøjte med din hånd, ved brug af din tommel- og pegefinger.
English: After 24 months, adverse reactions were reported in 41.5% (132/318) and 50% (164/328) of abatacept and adalimumab-treated patients.
Danish: Efter 24 måneder blev der rapporteret om bivirkninger hos 41,5% (132/318) og 50% (164/328) af patienterne, der blev behandlet med abatacept og adalimumab.
English: 50 mg/0.4 mL: white Plunger
Danish: 50 mg/0.4 ml: hvidt stempel
English: Patients treated with ORENCIA may receive concurrent vaccinations, except for live vaccines.
Danish: Patienter, der behandles med ORENCIA, kan vaccineres under behandlingen, dog ikke med levende vacciner.
English: In post-marketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA has been reported.
Danish: Efter markedsføring er der rapporteret om et tilfælde af dødelig anafylaksi efter første infusion af ORENCIA.
English: Do not use the vial if a vacuum is not present.
Danish: Brug ikke hætteglasset, hvis der ikke er vakuum.
English: In SC-II, serious infections were reported in 3.8 % (12/318) of patients treated with abatacept SC weekly, none of which led to discontinuation and in 5.8 % (19/328) of patients treated with adalimumab SC every-other-week, leading to 9 discontinuations in the 24-month period.
Danish: I SC-II blev der rapporteret om alvorlige infektioner hos 3,8% (12/318) af de patienter, som blev behandlet ugentligt med abatacept s.c., hvoraf ingen medførte seponering, og hos 5,8% (19/328) af de patienter, der blev behandlet med adalimumab s.c. hver anden uge, hvilket medførte seponering hos 9 i løbet af 24-måneders-perioden.
English: Abatacept was evaluated in an open-label study in rheumatoid arthritis patients administered the 23valent pneumococcal vaccine.
Danish: Abatacept blev undersøgt i et åbent studie hos patienter med reumatoid artritis, der fik den 23-valente pneumokokvaccine.
English: Abatacept is produced by recombinant DNA technology in Chinese hamster ovary cells.
Danish: Abatacept fremstilles ved rekombinant DNA-teknologi i OHC-celler (Chinese hamster ovarian cells).
English: The recommended dose of ORENCIA for patients 6 to 17 years of age with polyarticular juvenile idiopathic arthritis who weigh less than 75 kg is 10 mg/kg calculated based on the patient's body weight at each administration.
Danish: Den anbefalede dosis ORENCIA til patienter på 6-17 år med polyartikulær juvenil idiopatisk artritis, som vejer under 75 kg, er 10 mg/kg, hvilket udregnes på baggrund af patientens kropsvægt ved hver administration.
English: If a single intravenous dose is given to start the treatment, the first subcutaneous injection of ORENCIA should be given within a day of the intravenous infusion, followed by the weekly 125 mg subcutaneous injections.
Danish: Hvis du får en enkelt intravenøs dosis for at begynde behandling, skal du have den første subkutane indsprøjtning af ORENCIA på samme dag som den intravenøse infusion efterfulgt af ugentlige subkutane indsprøjtninger med 125 mg.
English: In study IV, there were 37 patients with COPD treated with intravenous abatacept and 17 treated with placebo.
Danish: I studie IV blev 37 patienter med KOL behandlet med intravenøst abatacept, og 17 med placebo.
English: During the cumulative study period when all subjects treated with abatacept in 7 SC studies were included, the frequency of injection site reactions was 4.6% (116/2,538) with an incidence rate of 1.32 per 100 person-years.
Danish: Under den samlede forsøgsperiode hvor alle forsøgspersoner, der blev behandlet med abatacept i 7 SC-studier, blev medtaget, var hyppigheden for reaktioner på injektionsstedet 4,6% (116/2.538) med en incidensrate på 1,32 pr. 100 personår.
English: Studies indicate that naive T lymphocyte responses are more affected by abatacept than memory T lymphocyte responses.
Danish: studier indikerer, at det naive T-lymfocytrespons påvirkes mere af abatacept end memory Tlymfocytresponset.
English: Antibodies directed against the whole abatacept molecule or to the CTLA-4 portion of abatacept were assessed by an ECL assay in patients with pJIA following repeated treatment with subcutaneous abatacept.
Danish: Antistoffer rettet mod hele abatacept molekylet eller CTLA-4-delen af abatacept blev vurderet ved et ECL-assay hos patienter med pJIA efter gentagne behandlinger med subkutan abatacept.
English: You can press a cotton ball or gauze over the injection site.
Danish: Du kan presse en vattot eller gaze mod injektionsstedet.
English: Physical function response
Danish: Respons i fysisk funktion
English: Very common (may affect more than 1 in 10 people): infections of the upper airway (including infections of the nose, throat and sinuses).
Danish: Meget almindelige (kan påvirke flere end 1 ud af 10 personer): infektioner i de øvre luftveje (herunder infektioner i næse, hals og bihuler).
English: The pJIA SC study included 46 patients in the 2 to 5 year age cohort and 173 patients in the 6 to 17 year age cohort.
Danish: pJIA s.c.-studiet inkluderede 46 patienter i aldersgruppen 2-5 år og 173 patienter i aldersgruppen 6-17 år.
English: In study SC-I, the goal was to demonstrate non-inferiority of the efficacy and comparability of the safety of abatacept subcutaneous relative to intravenous administration in subjects with moderate to severely active RA and experiencing inadequate response to MTX.
Danish: I studie SC-I var formålet at påvise non-inferioritet i virkning og sammenlignelighed i abatacepts sikkerhed ved subkutan og intravenøs administration til forsøgspersoner med moderat til svær aktiv RA og med utilstrækkeligt respons på MTX.
English: When receiving ORENCIA, patients that require blood glucose monitoring should be advised to consider methods that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase, or glucose hexokinase test methods.
Danish: Patienter med behov for kontrol af blodglucoseniveauet bør under behandling med ORENCIA tilrådes anden metode, der ikke reagerer på maltose, fx en metode baseret på glucosedehydrogenase-nicotinadenindinucleotid (GDH-NAD), glucoseoxidase eller glucosehexokinase.
English: Doses up to 50 mg/kg have been administered intravenously without apparent toxic effect.
Danish: Der er administreret intravenøse doser på op til 50 mg/kg uden åbenlys toksisk effekt.
English:  Supplies checklist: alcohol swabs, cotton ball or gauze, adhesive plaster, Sharps container.
Danish:  Tjekliste: spritservietter, vatrondel eller gaze, hæfteplaster, kanyleboks.
English: The effects of ORENCIA in pregnancy are not known, so you should not be given ORENCIA if you are pregnant unless your doctor specifically recommends it.
Danish: Effekten af ORENCIA på graviditet kendes ikke, så du må ikke få behandling med ORENCIA, hvis du er gravid, medmindre lægen specifikt anbefaler det.
English: P-valuea
Danish: P-værdia
English: Your doctor will advise you on the duration of treatment and what other medicines you may continue to take while on ORENCIA.
Danish: Lægen vil rådgive dig om, hvor længe du skal have ORENCIA og om, hvilken anden medicin du kan fortsætte med, mens du er i behandling med ORENCIA.
English: DO NOT replace the cap on the used Pen.
Danish: DU MÅ IKKE sætte hætten tilbage på den brugte pen.
English: Keep refrigerated until ready to use.
Danish: Opbevar den i køleskab, indtil du skal anvende den.
English: Most randomised Period B patients entered Period C (58/60 Period B abatacept recipients; 59/62 Period B placebo recipients), as did 36 of the 47 Period A non-responders (n=153 total patients).
Danish: Størstedelen af de patienter, der blev randomiseret til periode B, deltog i periode C (58/60 periode B abatacept-modtagere; 59/62 periode B placebo-modtagere), ligesom 36 af de 47 patienter, der ikke responderede i periode A (n=153 samlet antal patienter), deltog.
English: After reconstitution and dilution, the infusion solution is stable for 24 hours in a refrigerator, but for bacteriological reasons, it is to be used immediately.
Danish: Infusionsvæsken er holdbar i 24 timer i køleskab efter rekonstituering og fortynding, men bør af bakteriologiske årsager anvendes straks.
English: Administration: when reconstitution and dilution are performed under aseptic conditions ORENCIA infusion solution can be used immediately or within 24 hours if stored refrigerated at 2°C to 8°C.
Danish: Administration: hvis rekonstituering og fortynding er udført under aseptiske forhold, kan ORENCIAinfusionsvæsken anvendes straks eller inden for 24 timer, såfremt det opbevares i køleskab ved 2°C - 8°C.
English: For instructions on preparation of the medicinal product before administration, see section 6.6.
Danish: For instruktioner om klargøring af lægemidlet inden administration, se pkt.
English: Flare was defined as: ≥ 30% worsening in at least 3 of the 6 pJIA core set variables ≥ 30% improvement in not more than 1 of the 6 pJIA core set variables ≥ 2 cm (possible up to 10 cm) of worsening must have been present if the Physician or Parent Global Assessment was used to define flare worsening in ≥ 2 joints must have been present if the number of active joints or joints with limited range of motion was used to define flare
Danish: Opblussen blev defineret som; ≥ 30% forværring af mindst 3 af de 6 kernevariabler ved pJIA ≥ 30% forbedring i ikke mere end 1 af de 6 kernevariabler ved pJIA ≥ 2 cm (muligvis op til 10 cm) forværring skal have været til stede, hvis læge eller forældre Global Assessment blev anvendt til at definere opblussen forværring af ≥ 2 led skal have været til stede, hvis antallet af aktive led eller led med nedsat bevægelighed blev anvendt til at definere opblussen
English: Vial (15 mL Type 1 glass) with a stopper (halobutyl-rubber) and flip off seal (aluminium).
Danish: Hætteglas (15 ml Type 1 glas) med gummiprop (halobutylgummi) og flip-off forsegling (aluminium).
English: In addition, study V investigated the safety and efficacy of abatacept or infliximab relative to placebo.
Danish: Derudover undersøgte studie V sikkerhed og effekt af abatacept eller infliximab i forhold til placebo.
English: Patients entered in the trial were a mean 10.6 years of age with mean disease duration of 2.4 years.
Danish: Patienterne der indgik i studiet var i gennemsnit 10,6 år gamle med en gennemsnitlig sygdomsvarighed på 2,4 år.
English: Embryo-foetal development studies were conducted with abatacept in mice, rats, and rabbits at doses up to 20 to 30 times a human 10 mg/kg dose and no undesirable effects were observed in the offspring.
Danish: Der er udført embryo-føtale udviklingsstudier med abatacept på mus, rotter og kaniner i doser på op til 20-30 gange den humane dosis på 10 mg/kg, og der sås ingen bivirkninger hos afkommet.
English: There have been reports of tuberculosis in patients receiving ORENCIA (see section 4.8).
Danish: Der er rapporteret om tuberkulose hos patienter, der får ORENCIA (se pkt.
English: You will be trained by your doctor or nurse on how to self-inject ORENCIA using the pre-filled syringe.
Danish: Lægen eller sygeplejersken vil undervise dig i, hvordan du selv indsprøjter ORENCIA ved hjælp af den fyldte injektionssprøjte.
English: Abatacept was also evaluated in an open-label study in rheumatoid arthritis patients administered the seasonal influenza trivalent virus vaccine.
Danish: Abatacept blev også undersøgt i en åben undersøgelse med patienter med reumatoid artritis, der blev vaccineret med sæsonbestemt trivalent influenzavaccine.
English: The rate of seropositivity while patients were receiving abatacept therapy was 0.5% (1/189) during Period A; 13.0% (7/54) during Period B; and 12.8% (19/148) during Period C. For patients in Period B who were randomised to placebo (therefore withdrawn from therapy for up to 6 months) the rate of seropositivity was 40.7% (22/54).
Danish: Det seropositive niveau, mens patienterne fik behandling med abatacept, var 0,5% (1/189) i periode A; 13,0% (7/14) i periode B; og 12,8% (19/148) i periode C. Hos patienter i periode B, som blev randomiseret til placebo (og derfor taget ud af behandling i op til 6 måneder), var det seropositive niveau 40,7% (22/54).
English: By finding the right treatment plan for you, you may be able to slow down this disease process, which may help reduce long-term joint damage, as well as pain and fatigue and improve your overall quality of life.
Danish: Ved at finde en behandlingsplan, der passer til dig, kan man hæmme sygdomsudviklingen og derved på lang sigt mindske ledskader såvel som smerter og træthed.
English: The primary outcome, incidence of AEs, SAEs, and discontinuations due to AEs during 6 months of treatment, was similar between those who were previous and current TNF-inhibitor users at enrollment, as was the frequency of serious infections.
Danish: Det primære resultat, forekomst af bivirkninger og alvorlige bivirkninger og seponering på grund af bivirkninger i løbet af de 6 behandlingsmåneder, var det samme for tidligere og aktuelle brugere af TNF-hæmmere på tilmeldingspunktet.
English: The other ingredients are maltose, sodium dihydrogen phosphate monohydrate and sodium chloride (see section 2 "ORENCIA contains sodium").
Danish: Øvrige indholdsstoffer: maltose, natriumdihydrogenphosphat monohydrat og natriumchlorid (se afsnit 2 ”ORENCIA indeholder natrium”).
English: At 24 months, 50.6% (127/251) [95% CI: 44.4, 56.8] of patients in abatacept and 53.3% (130/244) [95% CI: 47.0, 59.5] of patients in adalimumab groups achieved DAS 28 < 2.6.
Danish: Ved 24 måneder nåede 50,6% (127/251) [95% CI: 44,4, 56,8] af patienterne i abatacept-gruppen og 53,3% (130/244) [95% CI: 47,0, 59,5] af patienterne i adalimumab-gruppen DAS 28 < 2,6.
English: There is a theoretical concern that treatment with abatacept might increase the risk for autoimmune processes in adults, for example deterioration of multiple sclerosis.
Danish: Der er teoretiske overvejelser om, hvorvidt behandling med abatacept kan øge risikoen for autoimmune processer hos voksne fx forværring af dissemineret sklerose.
English: The pJIA IV study included 190 patients in the 6 to 17 year age cohort.
Danish: pJIA IV-studiet inkluderede 190 patienter i aldersgruppen 6-17 år.
English: Check that the expiry date and batch number match the ones on the carton.
Danish: Kontroller at udløbsdato og batchnummer på injektionssprøjten er de samme som på æsken.
English: o Patient alert card: o A warning message for healthcare professionals treating the patient at any time, including in conditions of emergency, that the patient is using ORENCIA o That ORENCIA treatment may increase the risk of infections and allergic reactions.
Danish: o Advarselskort til patienter: o En advarsel til sundhedspersoner, der på et vilkårligt tidspunkt behandler patienten, herunder i nødsituationer, om at patienten bruger ORENCIA.
English: The powder is a white to off-white whole or fragmented cake.
Danish: Pulveret er hvidt til gråhvidt, i en hel eller fragmenteret blok.
English: Prior to administration, the ORENCIA solution should be inspected visually for particulate matter and discolouration.
Danish: Inden administration skal ORENCIA-væsken efterses for partikelholdigt materiale og misfarvning.
English: Each mL contains 25 mg of abatacept, after reconstitution.
Danish: Hver ml indeholder 25 mg abatacept efter rekonstituering.
English: Study V patients were randomised to receive this same fixed dose of abatacept or 3 mg/kg infliximab or placebo for 6 months.
Danish: Patienterne i studie V randomiseredes til samme faste abataceptdosis eller 3 mg/kg infliximab eller placebo i 6 måneder.
English: Patients were allowed to receive stable doses of concomitant methotrexate, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial.
Danish: Patienterne havde tilladelse til samtidigt at modtage methotrexat i konstante doser, lave doser kortikosteroider (ækvivalent til ≤ 10 mg prednison) og/eller NSAID'er under studiet.
English: A single study was conducted to determine the effect of monotherapy use of abatacept on immunogenicity following subcutaneous administration without an intravenous load.
Danish: Der blev udført et enkelt studie med henblik på at bedømme effekten af abatacept på immunogeniciteten, når abatacept blev givet i monoterapi som subkutan administration uden intravenøs initialdosis.
English: Rash (including dermatitis)
Danish: Almindelig Udslæt (inklusive dermatitis) Ikke almindelig
English: If any serious allergic or anaphylactic reaction occurs, intravenous or subcutaneous ORENCIA therapy should be discontinued immediately and appropriate therapy initiated, and the use of ORENCIA should be permanently discontinued.
Danish: Hvis der opstår alvorlige allergiske eller anafylaktiske reaktioner, skal intravenøs eller subkutan behandling med ORENCIA straks afbrydes og relevant behandling påbegyndes, og ORENCIA skal seponeres permanent.
English: After proper training in subcutaneous injection technique, a patient or caregiver may inject with ORENCIA if a physician/healthcare professional determines that it is appropriate.
Danish: Efter at have fået behørig undervisning i subkutan injektionsteknik kan patienten eller omsorgspersonen injicere ORENCIA, hvis lægen beslutter, at det er hensigtsmæssigt.
English: In study SC-III, similar immunogenicity rates were seen in patients on treatment for the abatacept+MTX, and abatacept monotherapy groups (2.9% (3/103) and 5.0% (5/101), respectively) during the double-blind 12 month period.
Danish: I studie SC-III blev sammenlignelig immunogenicitet observeret hos patienter i behandling med abatacept+MTX og abatacept-monoterapi (henholdsvis 2,9% (3/103) og 5,0% (5/101)) i løbet af den dobbeltblinde 12 måneders periode.
English: Patients were allowed to receive stable doses of concomitant methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, low dose corticosteroids (equivalent to ≤ 10 mg of prednisone) and/or NSAIDs during the trial.
Danish: Patienterne havde tilladelse til samtidigt at modtage methotrexat, sulfasalazin, lefunomid, hydroxychloroquin, lave doser kortikosteroider (ækvivalent til ≤ 10 mg prednison) og/eller NSAID'er under studiet.
English: ORENCIA is used to: slow down the damage to joints improve physical function improve other signs and symptoms of polyarticular juvenile idiopathic arthritis
Danish: ORENCIA anvendes til: at forsinke skade på led at forbedre fysisk funktionsevne at bedre andre tegn og symptomer på børnegigt