FrancophonIA/ELRC3.0 huggingface dataset:
English: Severe and uncontrolled infections such as sepsis and opportunistic infections (see section 4.4).
Danish: Svære og ubehandlede infektioner, som for eksempel sepsis og opportunistiske infektioner (se pkt.
English: The symptoms described above can be signs of the side effects listed below, all of which have been observed with ORENCIA in adult clinical trials:
Danish: Ovenstående symptomer kan være tegn på følgende bivirkninger, som alle er blevet observeret med ORENCIA hos voksne personer i kliniske studier:
English: Read the package leaflet for the shelf-life of the reconstituted product.
Danish: Se indlægssedlen for holdbarhed af det rekonstituerede produkt.
English: Comparison of incidence rates across different assays is not appropriate, as the ECL assay was developed to be more sensitive and drug tolerant than the previous ELISA assay.
Danish: En sammenligning af incidensraten analyserne imellem er ikke hensigtsmæssig, da ECL-analysen er udviklet til at være mere følsom og lægemiddeltolerant end den tidligere ELISA-analyse.
English: A major costimulatory pathway involves the binding of CD80 and CD86 molecules on the surface of antigen presenting cells to the CD28 receptor on T lymphocytes (signal 2).
Danish: Et væsentligt co-stimulatorisk led involverer binding af CD80- og CD86-molekyler på overfladen af celler med antigener for CD28-receptoren på T-lymfocytter (signal 2).
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C.
Danish: Der er vist kemisk og fysisk holdbarhed i 24 timer ved 2°C - 8°C.
English: Check the liquid through the viewing window.
Danish: Undersøg væsken gennem vinduet.
English: Three patients had SAEs (postoperative wound infection, H1N1 influenza, and myocardial ischemia in 1 patient each) that were not considered related to the study drug.
Danish: Tre patienter fik alvorlige bivirkninger (postoperativ sårinfektion, H1N1-influenza og myokardieiskæmi hver især hos 1 patient), som ikke blev anset for at være relateret til studiemedicinen.
English: Estimate of difference (95% CI)
Danish: Estimeret forskel (95% CI)
English: No difference in clinical response between subcutaneous and intravenous abatacept was seen across the 3 weight groups.
Danish: Der blev ikke observeret nogen forskel i klinisk respons mellem subkutant og intravenøst abatacept på tværs af de 3 vægtgrupper.
English: Upper respiratory tract infection (including tracheitis, nasopharyngitis, and sinusitis)
Danish: Øvre luftvejsinfektion (inklusive tracheitis, nasopharyngitis og sinusitis)
English: Intravenous use after reconstitution and dilution.
Danish: Til intravenøs anvendelse efter rekonstituering og fortynding.
English: In study SC-II, structural joint damage was assessed radiographically and expressed as a change from baseline in the van der Heijde-modified Total Sharp Score (mTSS) and its components.
Danish: Studie SC-II vurderede strukturel ledskade radiografisk udtrykt som ændringen i forhold til baseline i van der Heijde modificeret total Sharp score (mTSS) og dets komponenter.
English: No clinical impact of these antibody responses was detected, and no safety concerns were observed upon reinitiation of abatacept therapy.
Danish: Der blev ikke påvist nogen klinisk effekt af dette antistofrespons, og ingen sikkerhedsproblemer blev observeret ved genoptagelse af abatacept-behandling.
English: Ask your doctor or pharmacist for advice before taking any other medicine while using ORENCIA.
Danish: Spørg lægen eller apoteket om råd, inden du tager anden medicin samtidig med, at du får behandling med ORENCIA.
English: Insert the needle with a quick motion into the pinched skin at a 45° angle (Figure 5).
Danish: Stik med en hurtig bevægelse kanylen ind i den fastklemte hud i en vinkel på 45° (Figur 5).
English: A reduction in the progression of joint damage and improvement of physical function have been demonstrated during combination treatment with abatacept and methotrexate.
Danish: Der er vist reduktion i progression af ledskade og forbedring i fysisk funktion med kombinationsbehandling med abatacept og methotrexat.
English: The absence of concomitant methotrexate did not appear to be associated with a higher rate of seropositivity.
Danish: Fraværet af samtidig methotrexat ansås ikke for at være associeret med højere hyppighed af seropositivitet.
English: If neurological symptoms suggestive of PML occur during ORENCIA therapy, treatment with ORENCIA should be discontinued and appropriate diagnostic measures initiated.
Danish: Hvis der opstår neurologiske symptomer, der tyder på PML, under behandling med ORENCIA, bør behandlingen stoppes og nødvendige diagnostiske foranstaltninger igangsættes.
English: *Note: the figure shows the 50 mg pre-filled syringe Proceed to Step 3
Danish: *Bemærk: figuren viser den 50 mg fyldte injektionssprøjte Fortsæt til Trin 3
English: Adverse reactions in patients with chronic obstructive pulmonary disease (COPD)
Danish: Bivirkninger hos patienter med kronisk obstruktiv lungesygdom (KOL)
English: Ask your doctor, nurse, or pharmacist about national and local laws regarding the proper disposal of medical products that contain needles.
Danish: Spørg lægen, sundhedspersonalet eller på apoteket om korrekt bortskaffelse af lægemidler, der indeholder kanyler.
English: There is no relevant use of ORENCIA in children under two years old.
Danish: Det er ikke relevant at bruge ORENCIA hos børn under 2 år
English: The mean distribution volume (Vss) was 0.07 L/kg and ranged from 0.02 to 0.13 L/kg.
Danish: Det gennemsnitlige fordelingsvolumen (Vss) var 0,07 l/kg og spændte fra 0,02 til 0,13 l/kg.
English: Do not use if your pre-filled syringe does not have the correct amount of liquid.
Danish: Brug den ikke, hvis den fyldte injektionssprøjte ikke har den korrekte mængde væske.
English: If you received ORENCIA while you were pregnant, your baby may be at a higher risk for getting such an infection for up to approximately 14 weeks after the last dose you received during pregnancy.
Danish: Hvis du har fået ORENCIA, imens du var gravid, har din baby en større risiko for at få sådan en infektion i op til ca. 14 uger efter, du fik den sidste dosis under graviditeten.
English: if you have any kind of infection, including long-term or localised infection, if you often get infections or if you have symptoms of infection (e.g. fever, malaise, dental problems), it is important to tell your doctor.
Danish: ved enhver form for infektion, også længerevarende eller lokal infektion, hvis du ofte får infektioner eller hvis du har symptomer på infektion (for eksempel feber, utilpashed, tandproblemer) er det vigtigt, at du kontakter din læge.
English: c Health Assessment Questionnaire; 0 = best, 3 = worst; 20 questions; 8 categories: dressing and grooming, arising, eating,
Danish: c HAQ; 0 = bedst, 3 = værst; 20 spørgsmål; 8 kategorier: påklædning og soignering, stå op, spise, gå, hygiejne, nå, gribe og aktiviteter.
English: No systemic accumulation of abatacept occurred upon continued repeated treatment with 10 mg/kg at monthly intervals in rheumatoid arthritis patients.
Danish: Der var ingen systemisk akkumulering af abatacept ved gentagen behandling med 10 mg/kg med månedlige intervaller hos patienter med reumatoid artritis.
English: Patients entering the two PsA studies had mild to moderate psoriasis with median PASI scores of 8.6 in PsA-I and 4.5 in PsA-II.
Danish: Patienterne som indgik i to PsA studier havde mild til moderat psoriasis med median PASI-scores på 8,6 i PsA-I og 4,5 i PsA-II.
English: A. Choose an area of your body for the injection (injection site) You can use: o the front of your thigh o your abdomen, except for the 5 cm area around the navel (Figure 3).
Danish: A. Vælg et område på kroppen til indsprøjtningen (injektionssted) Du kan vælge: o forsiden af låret o maven, undtagen 5 cm rundt om navlen (Figur 3).
English: If you have received ORENCIA while you were pregnant, it is important that you inform the baby's health care personnel before any vaccinations are given to your baby.
Danish: Hvis du har fået ORENCIA, mens du var gravid, er det vigtigt, at du fortæller det til sundhedspersonalet, inden din baby får nogen som helst form for vaccination.
English: Injection Areas Self-Injection and Caregiver
Danish: Injektionsområder Selvinjektion og omsorgsperson
English: The total content (1 mL) of the pre-filled pen should be administered as a subcutaneous injection only.
Danish: Det totale indhold (1 ml) i den fyldte pen bør udelukkende administreres som subkutan injektion.
English: ORENCIA solution for injection is injected under the skin (subcutaneous use).
Danish: ORENCIA injektionsvæske indsprøjtes under huden (subkutan).
English: Because there is a higher incidence of infections and malignancies in the elderly in general, caution should be used when treating the elderly (see section 4.8).
Danish: Da der generelt er højere forekomst af infektioner og maligniteter i denne population, bør der udvises forsigtighed ved behandling af ældre patienter (se pkt.
English: Immunogenicity to abatacept following long-term subcutaneous administration was assessed by a new electrochemiluminescence (ECL) assay.
Danish: Abatacepts immunogenicitet efter langvarig subkutan anvendelse blev undersøgt ved en ny elektrokemiluminescens (ECL)-analyse.
English: In Period A all patients received 10 mg/kg of abatacept on days 1, 15, 29, 57 and 85 and were assessed on day 113.
Danish: I periode A fik alle patienter 10 mg abatacept/kg på dag 1, 15, 29, 57 og 85 og blev vurderet på dag 113.
English: DAS28 response
Danish: DAS28-respons
English: e DAS28-CRP Remission is defined as a DAS28-CRP score < 2.6
Danish: e DAS28-CRP-remission defineres som en DAS28-CRP score < 2,6
English: Description of selected adverse reactions Infections
Danish: Beskrivelse af udvalgte bivirkninger Infektioner
English: There may be a little bleeding at the injection site.
Danish: Det kan bløde lidt på injektionsstedet.
English: A. Check the expiry date and batch number on the carton The expiry date can be found on the ORENCIA carton and on each syringe.
Danish: A. Tjek udløbsdato og batchnummer på æsken Udløbsdatoen står på æsken og på hver injektionssprøjte.
English: Important instructions for use.
Danish: Vigtig brugervejledning.
English: Age and gender (when corrected for body weight) did not affect apparent clearance.
Danish: Alder og køn (korrigeret for kropsvægt) påvirkede ikke den tilsyneladende clearance.
English: Anti-abatacept antibodies were generally transient and of low titer.
Danish: Anti-abatacept-antistoffer var generelt forbigående og af lav titer.
English: Sharps containers are special puncture-resistant disposal bins that can be bought at many retail outlets.
Danish: En kanyleboks er en speciel affaldsbeholder til spidse genstande, som kan købes i en række detailforretninger.
English: In SC-III the safety profiles of the three treatment groups (abatacept + MTX, abatacept monotherapy, MTX group) were overall similar.
Danish: I SC-III var sikkerhedsprofilen i de tre behandlingsgrupper (abatacept + MTX, abatacept-monoterapi, MTX-gruppen) generelt sammenlignelig.
English: In the 2 to 5 year age cohort, 39 (84.8%) patients completed 2 years.
Danish: I aldersgruppen 2-5 år gennemførte 39 (84,8%) patienter 2 år.
English: There were six overall discontinuations during this period, only one of which was due to an AE (the SAE of post-operative wound infection).
Danish: Der var i alt seks personer, der seponerede medicinen i denne periode, hvoraf kun et tilfælde skyldtes en bivirkning (postoperativ sårinfektion).
English: Patients had active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite prior treatment with DMARD therapy and had one qualifying psoriatic skin lesion of at least 2 cm in diameter.
Danish: Patienterne havde aktiv PsA ((≥ 3 hævede led og ≥ 3 ømme led) på trods af tidligere behandling med DMARD og havde én kvalificeret hudlæsion forårsaget af psoriasis som var mindst 2 cm i diameter.
English: Liver function test abnormal (including transaminases increased)
Danish: Almindelig Unormal leverfunktionstest (herunder øget transaminase)
English: In patients assessed for anti-abatacept antibodies after discontinuation of abatacept (> 42 days after last dose), 103 of 1,888 (5.5%) were seropositive.
Danish: Blandt patienter, der blev vurderet for antistoffer efter seponering af abatacept (> 42 dage efter sidste dosis), var 103 ud af 1.888 (5,5%) seropositive.
English: Read these instructions before you use the ClickJect Pre-filled Pen.
Danish: Læs denne vejledning omhyggeligt, før du anvender den fyldte ClickJect-pen.
English: Reconstitution and dilution should be performed in accordance with good practices rules, particularly with respect to asepsis.
Danish: Rekonstitution og fortynding skal udføres i overensstemmelse med regler for god fremstillingspraksis særligt med hensyn til aseptisk fremstilling.
English: Administration of live vaccines to infants exposed to abatacept in utero is not recommended for 14 weeks following the mother's last exposure to abatacept during pregnancy.
Danish: Det anbefales ikke at administrere levende vacciner til spædbørn, som har været eksponeret for abatacept in utero, i 14 uger efter moderens sidste abatacept-eksponering under graviditeten.
English: Infections were the most commonly reported adverse events in patients with pJIA.
Danish: Infektioner var de hyppigst indrapporterede bivirkninger hos patienter med pJIA.
English: One patient was diagnosed with multiple sclerosis while in the extension period of the pJIA IV study.
Danish: Én patient blev diagnoseret med multipel sklerose under forlængelsesperioden af pJIA IV-studiet.
English: Overall, 6.9% (15/218) of subjects (cohorts combined) had a positive immunogenicity response relative to baseline during the cumulative period, including the 4-month short-term treatment period, 20-month extension treatment period and the 6-month post abatacept follow-up period.
Danish: Generelt havde 6,9% (15/218) af forsøgspersonerne (kombinerede kohorter) et positivt immunogenicitetsrespons i forhold til baseline under den kumulative periode, der omfatter den kortvarige behandlingsperiode på 4 måneder, forlængelsesperioden på 20 måneder og opfølgningsperioden på 6 måneder efter abatacept.
English: In people with rheumatoid arthritis the body's own immune system attacks normal body tissues, leading to pain and swelling of the joints.
Danish: Hos patienter med leddegigt angriber kroppens eget immunsystem normalt væv i kroppen, hvilket medfører smerter og hævede led.
English: Your doctor may start your ORENCIA treatment with or without a one-time dose of powder for concentrate for solution for infusion (given to you into a vein, usually in your arm, over a period of 30 minutes).
Danish: Lægen kan begynde behandlingen med ORENCIA med eller uden en enkelt dosis infusionsvæske (indgives i en blodåre (vene), sædvanligvis i armen, over en periode på 30 minutter).
English: Comparable trough concentrations across weight tiers and age groups were achieved by the body-weight-tiered subcutaneous dosing regimen.
Danish: Sammenlignelige dalkoncentrationer på tværs af vægtgrupperinger og aldersgrupper blev opnået ved den kropsvægtbaserede subkutane dosering.
English: In these studies, clinically and statistically significant improvement was observed in the abatacept group as compared with the placebo group in all 8 domains of the SF-36 (4 physical domains: physical function, role physical, bodily pain, general health; and 4 mental domains: vitality, social function, role emotional, mental health), as well as the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Danish: I disse studier sås klinisk og statistisk signifikant forbedring i abataceptgruppen sammenlignet med placebogruppen inden for alle 8 domæner i SF-36 (4 fysiske domæner: fysisk funktion, fysisk betingede begrænsninger, fysiske smerter, alment helbred; og 4 psykiske domæner: energi, sociale aktiviteter, psykisk betingede begrænsninger, psykisk velbefindende), såvel som i den fysiske totalscore (PCS) og den psykiske totalscore (MCS).
English: The time to and proportion of patients with the relapse of the disease observed between the two groups were similar.
Danish: Den observerede tid til og antallet af patienter med sygdomsrelaps var ens i de to grupper.
English: Abatacept decreases antigen specific TNFα, interferon-γ, and interleukin-2 production by T lymphocytes.
Danish: Abatacept hæmmer antigenspecifik dannelse af TNFα, interferon-γ og interleukin-2 fra T-lymfocytter.
English: Do not use prolonged or vigorous agitation.
Danish: Må ikke blandes langvarigt eller voldsomt.
English: Rheumatoid arthritis (RA) affects everyone differently.
Danish: RA påvirker mennesker forskelligt.
English: In vitro, abatacept attenuates human T lymphocyte activation as measured by decreased proliferation and cytokine production.
Danish: In vitro svækker abatacept human T-lymfocytaktivering målt ved nedsat proliferation og cytokinproduktion.
English: The type of serious infections was similar between the abatacept and placebo treatment groups (see section 4.4).
Danish: Typen på alvorlige infektioner var tilsvarende mellem de abatacept- og placebobehandlede grupper (se pkt.
English: A study in the subcutaneous program was conducted to investigate the effect of withdrawal (three months) and restart of abatacept subcutaneous treatment on immunogenicity.
Danish: I det subkutane program blev der udført et studie af effekten af seponering (tre måneder) og genoptagelse af subkutan abatacept-behandling på immunogenicitet.
English: The safety and efficacy of intravenous ORENCIA in children below 6 years of age have not been studied and therefore, intravenous ORENCIA is not recommended for use in children under six years old.
Danish: Sikkerhed og virkning af intravenøs ORENCIA er ikke undersøgt hos børn under 6 år, og derfor anbefales intravenøs ORENCIA ikke til børn under 6 år.
English: The pre-filled syringe has a flange extender that makes it easier to hold and inject, and a needle guard that automatically covers the needle after a complete injection.
Danish: Den fyldte injektionssprøjte har en udvidet flange, som gør den nemmere at holde og indsprøjte, og en beskyttelseshætte som automatisk dækker for kanylen efter endt indsprøjtning.
English: The GDH-PQQ based glucose monitoring systems may react with the maltose present in ORENCIA, resulting in falsely elevated blood glucose readings on the day of infusion.
Danish: GDH-PQQ-baserede glucosemonitoreringssystemer kan reagere på maltosen i ORENCIA, og dette kan medføre en falsk forhøjet blodglucosemåling på infusionsdagen.
English: The increased incidence of lymphomas and mammary tumours observed in mice treated with abatacept may have been associated with decreased control of murine leukaemia virus and mouse mammary tumour virus, respectively, in the presence of long-term immunomodulation.
Danish: Den øgede forekomst af lymfomer og mammatumorer hos mus behandlet med abatacept kan være forbundet med nedsat kontrol af henholdsvis det murine leukæmivirus og musemammatumorvirus ved længerevarende immunmodulering.
English: STEP 3: Inject ORENCIA
Danish: TRIN 3: Indsprøjt ORENCIA
English: The transparent tip locks over the needle once the injection is complete and the Pen is removed from the skin.
Danish: Den gennemsigtige spids låses over kanylen, når injektionen er slut og pennen fjernes fra huden.
English: Of the 190 patients with pJIA treated with intravenous ORENCIA, one (0.5%) patient discontinued due to non-consecutive infusion reactions, consisting of bronchospasm and urticaria.
Danish: Af de 190 patienter med pJIA, der blev behandlet med intravenøs ORENCIA, afbrød én (0,5%) patient behandlingen på grund af ikke-konsekutive infusionsrelaterede reaktioner i form af bronkospasme og urticaria.
English: Your doctor may recommend a different method for monitoring your blood glucose levels.
Danish: Lægen kan anbefale en anden metode til blodsukkerkontrol.
English: if you become pregnant while using ORENCIA, tell your doctor.
Danish: hvis du bliver gravid, mens du anvender ORENCIA, skal du informere lægen.
English: Reversible pharmacological effects consisted of minimal transient decreases in serum IgG and minimal to severe lymphoid depletion of germinal centres in the spleen and/or lymph nodes.
Danish: Reversible farmakologiske virkninger bestod af minimale, forbigående fald i serum-IgG og minimalt til svært lymfoidt tab i germinale centre i milten og/eller lymfekirtler.
English: Change injection site Each week you can use the same area of your body, but use a different injection site in that area.
Danish: Skift injektionssted Du kan bruge samme område hver uge, men du skal bruge et andet injektionssted inden for området.
English: The safety and efficacy of intravenous abatacept were assessed in a three-part study.
Danish: Sikkerhed og virkning af intravenøst abatacept blev vurderet i et tredelt studie.
English: The results were measured using the Genant-modified total Sharp score (TSS) and its components, the erosion score and joint space narrowing (JSN) score.
Danish: Resultaterne blev målt ved Genant-modificeret TSS (Total Sharp Score) og dets komponenter, erosionsscore og JSN-score (joint space narrowing).
English: Care of injection site:
Danish: Pleje af injektionsstedet:
English: The efficacy of subcutaneous abatacept in children 2 to 17 years of age is based on pharmacokinetic exposure and extrapolation of established efficacy from intravenous abatacept in pJIA patients and subcutaneous abatacept in adult patients with RA, and is supported by data from an ongoing clinical study.
Danish: Effekten af subkutan abatacept hos børn i alderen 2 til 17 år er baseret på farmakokinetisk eksponering og ekstrapolation af fastslået effekt fra intravenøs abatacept hos pJIA patienter og subkutan abatacept hos voksne patienter med RA, og er understøttet af data fra igangværende kliniske studier.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af PSUR'er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer og offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Do not use ORENCIA if you are allergic to abatacept or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke ORENCIA hvis du er allergisk over for abatacept eller et af de øvrige indholdsstoffer i ORENCIA (angivet i punkt 6).
English: One hundred and eighty-seven of 3,877 (4.8%) patients developed anti-abatacept antibodies while on treatment.
Danish: 187 ud af 3.877 patienter (4,8%) udviklede antistoffer mod abatacept under behandlingen.
English: Step 4: Choose and Prepare an Injection Site Choose your injection site in either the abdomen, front of the thighs, or outer area of upper arm (only if caregiver administered).
Danish: TRIN 4: Vælg og klargør et injektionssted Vælg dit injektionssted på enten maven, forsiden af låret eller det ydre område på overarmen (kun ved indgivelse af omsorgsperson).
English: What ORENCIA contains
Danish: ORENCIA indeholder
English: Other medicines: ORENCIA should not be mixed with other medicines or infused concomitantly in the same intravenous line with other medicines.
Danish: Anden medicin: ORENCIA må ikke blandes med andre lægemidler eller infunderes samtidig med andre lægemidler i samme infusionsslange.
English: ≥ 60 kg to ≤ 100 kg
Danish: ≥ 60 kg til ≤ 100 kg
English: Of the 219 patients entering the study, 56 (25.6%) had previously been treated with biologic DMARD therapy (including TNF inhibitors and tocilizumab).
Danish: Af de 219 patienter der indgik i studiet, havde 56 (25,6%) tidligere været behandlet med biologisk DMARDbehandling (inklusive TNF-hæmmere og tocilizumab).
English: Uncommon Conjunctivitis, dry eye, visual acuity reduced
Danish: Konjunktivitis, tørre øjne, nedsat synsskarphed