FrancophonIA/ELRC3.0 huggingface dataset:
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens, apotekspersonalets eller sundhedspersonalets anvisning.
English: Needle guard (extended over needle)
Danish: Beskyttelseshætte (sidder over kanylen)
English: The most common side effects with ORENCIA are infections of the upper airway (including infections of the nose and throat), headache and nausea, as listed below.
Danish: Som anført nedenfor er de hyppigste bivirkninger med ORENCIA infektioner i de øvre luftveje (herunder infektion i næse og hals), hovedpine og kvalme.
English: The recommended dose of abatacept for adults with rheumatoid arthritis or psoriatic arthritis is based on body weight:
Danish: Anbefalet dosis til voksne Den anbefalede dosis abatacept til voksne med leddegigt eller psoriasisgigt beregnes ud fra kropsvægt:
English: Concomitant medication, such as methotrexate, corticosteroids, and NSAIDs, did not influence abatacept apparent clearance.
Danish: Samtidig brug af medicin, såsom methotrexat, kortikosteroider og NSAIDs havde ikke indflydelse på den tilsyneladende clearence af abatacept.
English: Patients achieving at least a ACR Pedi 30 response at the end of Period A were randomised into a double-blind, withdrawal phase (Period B), and received either abatacept or placebo for 6 months or until pJIA disease flare as defined in the study.
Danish: De patienter, der fik minimum en ACR Pedi 30-respons i slutningen af periode A, blev randomiseret til en dobbeltblind seponeringsfase (periode B) og fik enten abatacept eller placebo i 6 måneder eller indtil opblussen af pJIA-sygdommen, som defineret i studiet.
English: Check the liquid in the pre-filled syringe through the viewing window.
Danish: Kontroller væsken i den fyldte injektionssprøjte igennem vinduet.
English: Tell your doctor immediately if you notice any of the following: severe rash, hives or other signs of allergic reaction swollen face, hands or feet trouble breathing or swallowing fever, persistent cough, weight loss, listlessness
Danish: Kontakt straks lægen, hvis du bemærker ét af følgende: alvorligt udslæt, nældefeber eller andre tegn på en overfølsomhedsreaktion hævet ansigt, hævede hænder eller fødder vejrtræknings- eller synkebesvær feber, vedvarende hoste, vægttab, sløvhed
English: A greater percentage of abatacept- than placebotreated patients with COPD developed a serious adverse reaction (5.4% vs. 0%), including COPD exacerbation (1 of 37 patients [2.7%]) and bronchitis (1 of 37 patients [2.7%]).
Danish: En større procentdel af de abatacept-behandlede end de placebobehandlede patienter med KOL udviklede alvorlig bivirkning (5,4% vs 0%), inklusive KOL-exacerbation (1 ud af 37 patienter [2,7%]) og bronkitis (1 ud af 37 patienter [2,7%]).
English: At 12 months, the incidence of AE of infections were 59.6% (93), 68.5% (113), and the incidence of serious AE of infections were 1.9% (3) and 8.5% (14) for abatacept and infliximab groups, respectively.
Danish: Ved 12 måneder var hyppigheden af bivirkninger, i form af infektioner, henholdsvis 59,6% (93) og 68,5% (113) og hyppigheden af alvorlige bivirkninger var henholdsvis 1,9% (3) og 8,5% (14) for abataceptgruppen og infliximabgruppen.
English: For patients 2 to 17 years of age with polyarticular juvenile idiopathic arthritis, the recommended weekly dose of ORENCIA solution for injection in pre-filled syringe is based on body weight:
Danish: Til patienter i alderen 2 til 17 år med børnegigt (polyartikulær juvenil idiopatisk artritis) er den anbefalede ugentlige dosis af ORENCIA injektionsvæske, opløsning, i fyldt injektionssprøjte baseret på kropsvægt.
English: C. Check the liquid in the syringe Hold the syringe by its body, with the covered needle pointing down.
Danish: C. Kontroller væsken i injektionssprøjten Hold cylinderen med den tildækkede kanyle pegende nedad.
English: Do not use if opaque particles, discolouration, or other foreign particles are present.
Danish: Må ikke bruges, hvis der er uigennemsigtige partikler, misfarvning eller andre fremmedlegemer tilstede.
English: Less than 60 kg
Danish: Under 60 kg
English: Hypertension, blood pressure increased Uncommon Hypotension, hot flush, flushing, vasculitis, blood pressure decreased
Danish: Hypotension, hedeture, rødmen, vaskulitis, nedsat blodtryk
English: Clinical efficacy and safety in adult psoriatic arthritis
Danish: Klinisk virkning og sikkerhed hos voksne med psoriasisartritis
English: Rare (may affect up to 1 in 1,000 people): tuberculosis inflammation of uterus, fallopian tubes and/or ovaries gastrointestinal infection cancer of white blood cells, lung cancer
Danish: Sjældne (kan påvirke op til 1 ud af 1.000 personer): tuberkulose underlivsbetændelse betændelse i mave-tarmkanalen kræft i de hvide blodlegemer, lungekræft
English: ORENCIA should be administered weekly at a dose of 125 mg by subcutaneous (SC) injection without the need for an intravenous (IV) loading dose.
Danish: ORENCIA skal administreres ugentligt i en dosis på 125 mg ved subkutan injektion, uden behov for en intravenøs (i.v.)
English: Higher ACR 20 responses in study PsA-II were seen with abatacept 125 mg subcutaneous vs. placebo irrespective of concomitant nonbiological DMARD treatment.
Danish: Højere ACR 20-respons blev observeret i studiet PsA-II med abatacept 125 mg subkutant vs. placebo uafhængig af samtidig ikke-biologisk behandling med DMARDs.
English: Talk to your doctor, pharmacist or nurse: if you experience allergic reactions such as chest tightness, wheezing, severe dizziness or lightheadedness, swelling or skin rash tell your doctor immediately.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger ORENCIA: hvis du oplever overfølsomhedsreaktioner, såsom trykken for brystet, hvæsen, svær svimmelhed eller ørhed, hævelse eller udslæt, skal du straks underrette lægen.
English: The incidence rate of autoimmune disorders in abatacept-treated patients during the double-blind period was 8.8 (7.6, 10.1) per 100 person-years of exposure and for placebo-treated patients was 9.6 (7.9, 11.5) per 100 person-years of exposure.
Danish: Incidensraten for autoimmune sygdomme hos abataceptbehandlede patienter under den dobbeltblinde periode var 8,8 (7,6, 10,1) pr. 100 personår og var hos placebobehandlede patienter 9,6 (7,9, 11,5) pr. 100 personår.
English: What ORENCIA looks like and contents of the pack ORENCIA powder for concentrate for solution for infusion is a white to off-white powder that can appear solid or broken into pieces.
Danish: ORENCIA pulver til koncentrat til infusionsvæske, opløsning er et hvidt til grålighvidt pulver, der kan være i fast form eller i mindre stykker.
English: Uncommon Increased tendency to bruise, dry skin, alopecia, pruritus, urticaria, psoriasis, acne, erythema, hyperhidrosis
Danish: Øget tendens til blå mærker, tør hud, alopeci, pruritus, urticaria, psoriasis, acne, erythema, hyperhidrose
English: Before you use the pre-filled syringe for the first time, make sure your doctor, nurse or pharmacist shows you the right way to use it.
Danish: Læs denne vejledning, før du anvender den fyldte ORENCIA injektionssprøjte Før du bruger den fyldte injektionssprøjte første gang, skal du sikre dig at din læge, sundhedspersonalet eller apotekspersonalet viser dig den korrekte måde at bruge den på.
English: No studies were conducted to examine the effects of either renal or hepatic impairment on the pharmacokinetics of abatacept.
Danish: Der er ikke udført studier af betydningen af nyre- og leverinsufficiens på abatacepts farmakokinetik.
English: Medicinal products that affect the immune system, including abatacept, may blunt the effectiveness of some immunisations.
Danish: Lægemidler, der påvirker immunsystemet, inklusive abatacept, kan svække effekten af visse immuniseringer.
English: o Signs or symptoms of the safety concern and when to seek attention from a healthcare professional o Contact details of the ORENCIA prescriber o A warning message for patients who have received ORENCIA while pregnant to inform healthcare personnel before any vaccination is given to the baby due to the potential risk of severe infection caused by immunization with live vaccines
Danish: o En advarsel til patienter, der har fået ORENCIA under graviditet, om at underrette sundhedspersoner, før barnet vaccineres, på grund af den potentielle risiko for alvorlige infektioner forårsaget af immunisering med levende vacciner.
English: How ORENCIA is given to you
Danish: Hvordan ORENCIA indgives
English: DO NOT use if it is cracked or broken.
Danish: DU MÅ IKKE bruge den, hvis den har revner eller er ødelagt.
English: Following the initial administration, ORENCIA should be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter.
Danish: Efter initial administration bør ORENCIA gives 2 uger og 4 uger efter den første infusion og derefter hver 4. uge.
English: A study of open-label abatacept on a background of nonbiologic DMARDs was conducted in patients with active RA who had an inadequate response to previous (washout for at least 2 months; n=449) or current (no washout period; n=597) TNF-inhibitor therapy (study VII).
Danish: En undersøgelse af åben abatacept på en baggrund af ikke-biologiske DMARDs blev gennemført hos patienter med aktiv reumatoid artritis, som havde utilstrækkeligt respons på tidligere (udvaskning i mindst 2 måneder; n = 449) eller aktuel (ingen udvaskningsperiode; n = 597) behandling med TNFhæmmer (studie VII).
English: Keep any remaining unused syringes in their original carton, in the refrigerator.
Danish: Lad resten af injektionssprøjterne blive i køleskabet i den originale æske.
English: * p < 0.05 vs placebo, p values not assessed for ACR 50 and ACR 70. a 37% of patients were previously treated with TNF inhibitor.
Danish: *p < 0,05 vs. placebo, p værdier ikke evalueret for ACR 50 og ACR 70.
English: Abatacept has been studied in patients with active psoriatic arthritis in two placebo-controlled clinical trials (341 patients with abatacept, 253 patients with placebo) (see Section 5.1).
Danish: Abatacept er blevet undersøgt hos patienter med aktiv psoriasisartritis i to placebokontrollerede kliniske studier (341 patienter modtog abatacept, 253 patienter modtog placebo) (se pkt.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 250 mg of abatacept.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 250 mg abatacept.
English: Of the 133 (70%) patients with no prior TNF-inhibitor therapy, 101 (76%) achieved at least an ACR Pedi 30 response; of the 57 patients who had received prior TNF-inhibitor therapy, 22 (39%) achieved at least an ACR Pedi 30 response.
Danish: Af de 133 (70%) patienter, som ikke tidligere havde været i behandling med en TNF-hæmmer, opnåede 101 (76%) som minimum en ACR Pedi 30respons.
English: The cumulative immunogenicity frequency to abatacept by the ECL assay with at least one positive sample in the short-term and long-term periods combined was 15.7% (215/1369) while on abatacept, with a mean duration of exposure of 48.8 months, and 17.3% (194/1121) after discontinuation (> 21 days up to 168 days after last dose).
Danish: Den kumulative forekomst af immunogenicitet ved abatacept med mindst en positiv prøve i den kombinerede korttids- og langtidsperiode var ifølge ECL-analysen 15,7% (215/1.369) under behandling med abatacept med en gennemsnitlig eksponeringsvarighed på 48,8 måneder og 17,3% (194/1121) efter seponering (> 21 dage og op til 168 dage efter sidste dosis).
English: Month 6 Month 12 76%‡
Danish: Måned 3 64%†† Måned 6 75%† Måned 12 76%‡
English: A greater percentage of abatacept- than placebo treated patients with COPD developed a serious adverse reaction (5.4% vs. 0%), including COPDexacerbation (1 of 37 patients [2.7%]) and bronchitis (1 of 37 patients [2.7%]).
Danish: En større procentdel af de abataceptbehandlede end de placebobehandlede patienter med KOL udviklede alvorlig bivirkning (5,4% vs 0%), inklusive KOLexacerbation (1 ud af 37 patienter [2,7%]) og bronkitis (1 ud af 37 patienter [2,7%]).
English: Respiratory disorders occurred more frequently in abatacept-treated patients than in placebo-treated patients (10.8% vs. 5.9%, respectively); these included COPD exacerbation, and dyspnea.
Danish: Respiratoriske forstyrrelser forekom oftere hos abataceptbehandlede patienter end placebobehandlede (henholdsvis 10,8% og 5,9%).
English: In rats, abatacept had no undesirable effects on male or female fertility.
Danish: Hos rotter havde abatacept ingen uønsket effekt på fertiliteten - hverken hos hanner eller hunner.
English: The recommended dose of ORENCIA for adults with rheumatoid arthritis or psoriatic arthritis is 125 mg given every week regardless of weight.
Danish: Den anbefalede dosis af ORENCIA til voksne med leddegigt eller psoriasisgigt er 125 mg en gang om ugen, uanset din vægt.
English: Co-administration of abatacept with biologic immunosuppressive or immunomodulatory agents could potentiate the effects of abatacept on the immune system.
Danish: Samtidig administration af abatacept og biologiske immunsuppressive eller immunmodulerende stoffer kan forstærke abatacepts effekt på immunsystemet.
English: The recommended dose of ORENCIA for adults with rheumatoid arthritis or psoriatic arthritis is 125 mg abatacept given every week regardless of weight.
Danish: Den anbefalede dosis af ORENCIA til voksne med leddegigt eller psoriasisgigt er 125 mg abatacept en gang om ugen, uanset din vægt.
English: ORENCIA is available in the following presentations: - pack of 4 pre-filled pens and multipack containing 12 pre-filled pens (3 packs of 4).
Danish: ORENCIA fås i følgende pakningsstørrelser: - pakninger med 4 fyldte penne og multipakninger med 12 fyldte penne (3 pakninger med hver 4).
English: DO NOT remove the needle cover from the Pen while allowing it to reach room temperature.
Danish: DU MÅ IKKE fjerne kanylehætten på pennen, mens den opnår stuetemperatur.
English: A randomised and double-blinded study evaluated abatacept SC in combination with methotrexate (abatacept + MTX), abatacept SC monotherapy, or methotrexate monotherapy (MTX group) in induction of remission following 12 months of treatment, and maintenance of drug-free remission after complete drug withdrawal in MTX-naive adult patients with highly active early rheumatoid arthritis with poor prognostic factors.
Danish: Et randomiseret og dobbeltblindt studie undersøgte abatacept s.c. i kombination med methotrexat (abatacept + MTX), abatacept s.c.-monoterapi eller methotrexat-monoterapi (MTX-gruppe) med hensyn til induktion af remission efter 12 måneders behandling, samt opretholdelse af lægemiddelfri remission efter seponering af alle lægemidlerhos MTX-naive voksne patienter med højaktiv, tidlig reumatoid artritis med faktorer, der indikerer en dårlig prognose.
English: Study VI
Danish: Studie VI
English: One mL pre-filled syringe (type 1 glass) with flange extenders or one mL pre-filled syringe with an automatic needle safety guard and flange extenders (orange plunger).
Danish: Én ml fyldt injektionssprøjte (type 1 glas) med udvidet flange eller én ml fyld injektionssprøjte med en automatisk kanylebeskyttelse og udvidet flange (orange stempel).
English: Orange plunger
Danish: Orange stempel
English: 1 mL Fill line
Danish: 1 ml Fyldelinje
English: A study of open-label intravenous abatacept on a background of nonbiologic DMARDs was conducted in patients with active RA who had an inadequate response to previous (washout for at least 2 months; n=449) or current (no washout period; n=597) TNF-inhibitor therapy (study VII).
Danish: En undersøgelse af åben intravenøst abatacept på en baggrund af ikke-biologiske DMARDs blev gennemført hos patienter med aktiv reumatoid artritis, som havde utilstrækkeligt respons på tidligere (udvaskning i mindst 2 måneder; n = 449) eller aktuel (ingen udvaskningsperiode; n = 597) behandling med TNF-hæmmer (studie VII).
English: ClickJect Pre-filled Pen
Danish: Fyldt ClickJect-pen
English: A total of 270 patients 65 years of age and older, including 46 patients 75 years and older, received subcutaneous abatacept in controlled clinical trials.
Danish: I alt 270 patienter i aldersgruppen 65 år eller derover, inklusive 46 patienter i aldersgruppen 75 år eller derover, blev behandlet subkutant med abatacept i kontrollerede kliniske studier .
English: In the placebo-controlled clinical trials, the frequencies of malignancies in abatacept- and placebotreated patients were 1.2% and 0.9%, respectively (see section 4.8).
Danish: I de placebo-kontrollerede, kliniske studier var hyppighed af maligniteter blandt de abatacept- og placebo-behandlede patienter henholdsvis 1,2% og 0,9% (se pkt.
English: Sodium dihydrogen phosphate monohydrate
Danish: Natriumdihydrogenphosphatmonohydrat Natriumchlorid
English: Abatacept 10 mg/kg IV N=40
Danish: Abatacept 10 mg/kg i.v.
English: − If you develop symptoms suggestive of infections, such as fever, persistent cough, weight loss, or listlessness, seek medical attention immediately.
Danish: − Hvis du får symptomer, som tyder på en infektion, såsom feber, vedvarende hoste, vægttab eller sløvhed, skal du straks kontakte lægen.
English: How to use ORENCIA
Danish: Sådan skal du bruge ORENCIA
English: Table 10:
Danish: Tabel 10:
English: A randomised, double-blind study was conducted to assess the safety and efficacy of abatacept or infliximab versus placebo in patients with an inadequate response to methotrexate (study V).
Danish: Der er gennemført et randomiseret dobbeltblindt studie med henblik på at vurdere sikkerhed og effekt af abatacept eller infliximab versus placebo hos patienter med utilstrækkeligt respons på methotrexat (studie V).
English: Similarly, the frequencies of serious infection and malignancy among subcutaneous abatacept-treated patients over age 65 were higher than among those under age 65.
Danish: Ligeledes var hyppigheden af alvorlig infektion og malignitet blandt intravenøst abataceptbehandlede patienter over 65 år højere end den, der sås hos patienter under 65 år.
English: You must stop breast-feeding if you are being treated with ORENCIA and for up to 14 weeks after the last dose.
Danish: Du skal holde op med at amme, mens du får behandling med ORENCIA og i op til 14 uger efter sidste dosis.
English: DAS28-Remission a Odds Ratio (95% CI) vs. MTX P value
Danish: DAS28-remissiona Odds Ratio (95% CI) versus MTX P-værdi
English: Tuberculosis, bacteraemia, gastrointestinal infection, pelvic inflammatory disease
Danish: Tuberkulose, bakteriæmi, mave-tarminfektion, underlivsbetændelse
English: The type 1 glass syringe has a coated bromobutyl stopper and fixed stainless steel needle covered with a rigid needle shield.
Danish: Type 1 glassprøjten har en beklædt bromobutylprop og fæstnet kanyle af rustfrit stål tildækket med en fast kanylehætte.
English: In study SC-I, ACR responses were assessed at 5 years with 85% (356/421) ACR 20 responses, 66% (277/423) ACR 50 responses, and 45% (191/425) ACR 70 responses.
Danish: I studie SC-I blev ACRresponset vurderet efter 5 år, hvor 85% (356/421) opnåede ACR 20 respons, 66% (277/423) opnåede ACR 50 respons, og 45% (191/425) opnåede ACR 70 respons.
English: Therefore, ORENCIA solution for injection in pre-filled pen is not recommended for use in this patient population.
Danish: Derfor bør ORENCIA injektionsvæske, i fyldt pen, ikke anvendes til denne patientgruppe.
English: Abatacept/methotrexate reduced the rate of progression of structural damage compared to placebo/methotrexate after 12 months of treatment as shown in Table 5.
Danish: Abatacept/methotrexat reducerede efter 12 måneders behandling progressionshastigheden af strukturel skade sammenlignet med placebo/methotrexat, vist i Tabel 5.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 125 mg of abatacept in one mL.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldt pen indeholder 125 mg abatacept i en ml.
English: Dispose of used ClickJect Pre-filled Pen into sharps disposal container right away after use.
Danish: Du skal kassere den brugte ClickJect-pen i kanyleboksen straks efter brug.
English: Headache, dizziness Uncommon Migraine, paraesthesia
Danish: Almindelig Hovedpine, svimmelhed Ikke almindelig
English: Abatacept/methotrexate reduced the rate of progression of structural damage compared to placebo/methotrexate after 12 months of treatment as shown in Table 4.
Danish: Abatacept/methotrexat reducerede efter 12 måneders behandling progressionshastigheden af strukturel skade sammenlignet med placebo/methotrexat, vist i Tabel 4.
English: Abatacept in pJIA patients has also been studied with the subcutaneous formulation in children and adolescents with moderate to severe active pJIA, ages 2 to 17 years with an inadequate response or intolerance to at least one DMARD, which may have included biologic agents.
Danish: Abatacept hos pJIA-patienter har også været undersøgt som subkutan formulering hos børn og unge i alderen 2 til 17 år med moderat til svær, aktiv pJIA, med et utilstrækkeligt respons eller intolerance overfor mindst en DMARD, som kan have indholdt et biologisk stof.
English: if you are using a blood glucose monitor to check your blood glucose levels.
Danish: hvis du bruger et apparat til at måle blodsukker.
English: In the smaller study PsA-I, the ACR 20 responses with abatacept 10 mg/kg intravenous vs placebo in patients who were TNF inhibitor-naive were 55.6% vs 20.0%, respectively, and in patients who were TNF inhibitorexperienced were 30.8% vs 16.7%, respectively.
Danish: I det mindre PsA-I-studie, blev ACR 20-responset med abatacept 10 mg/kg intravenøst vs. placebo hos patienter som var TNFhæmmer naive henholdsvis 55,6% vs. 20,0%.
English: However, dizziness and reduced visual acuity have been reported as common and uncommon adverse reactions respectively from patients treated with ORENCIA, therefore if a patient experiences such symptoms, driving and use of machinery should be avoided.
Danish: Svimmelhed og nedsat synsskarphed er dog rapporteret som henholdsvis almindeligt og ikke almindeligt forekommende bivirkninger hos patienter, der blev behandlet med ORENCIA.
English: Table 8:
Danish: Tabel 8.
English: Injection Reactions in adult patients treated with subcutaneous abatacept
Danish: Reaktioner på injektionsstedet hos voksne patienter, der behandles med subkutan abatacept
English: Do not use the pre-filled syringe if the needle is damaged or bent.
Danish: Du må ikke bruge den fyldte injektionssprøjte, hvis kanylen er beskadiget eller bøjet.
English: ORENCIA powder for concentrate for solution for infusion has not been studied in children and adolescents under 6 years of age, therefore ORENCIA powder for concentrate for infusion is not recommended for use in this patient population.
Danish: ORENCIA pulver til koncentrat til infusionsvæske, opløsning er ikke undersøgt hos børn og unge under 6 år, og bør derfor ikke anvendes til denne patientgruppe.
English: ORENCIA is used to treat rheumatoid arthritis and psoriatic arthritis in adults.
Danish: ORENCIA anvendes til behandling af leddegigt (reumatoid artritis - RA) og psoriasisartritis (psoriasisgigt) hos voksne.
English: ACR Pedi 30 responders at the end of Period A were randomised into Period B, the double-blind, withdrawal phase, to receive either abatacept or placebo for 6 months or until JIA flare.
Danish: Patienter, der fik ACR Pedi 30-respons i slutningen af periode A, blev randomiseret til periode B, den dobbeltblinde seponeringsfase, og fik enten abatacept eller placebo i 6 måneder eller indtil opblussen af JIA-sygdommen.
English: The frequencies of serious infection and malignancy relative to placebo among abatacept-treated patients over age 65 were higher than among those under age 65.
Danish: Hyppigheden af alvorlig infektion og malignitet i forhold til placebo blandt abatacept-behandlede patienter over 65 år var højere end den, der sås hos patienter under 65 år.
English: Immunogenicity in adults treated with intravenous abatacept
Danish: Immunogenicitet hos voksne, der behandles med intravenøst abatacept