FrancophonIA/ELRC3.0 huggingface dataset:
English: No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of ORENCIA with other medicines.
Danish: Der er ikke udført fysiske eller biokemiske forligelighedsstudier med henblik på, at evaluere samtidig administration af ORENCIA med andre lægemidler.
English: Proportion (%) of polyarticular JIA patients with ACR responses or inactive disease
Danish: Andel (%) af polyartikulære JIA-patienter med ACR-respons eller inaktiv sygdom
English: 6.6 Special precautions for disposal and other handling The medicinal product is for single use only.
Danish: 6.6 Regler for bortskaffelse og anden håndtering Dette lægemiddel er udelukkende til engangsbrug.
English: Study SC-III: Induction of remission in methotrexate-naive RA patients
Danish: Studie SC-III: Induktion af remission hos methotrexat-naive RA-patienter
English: Paediatric pJIA population
Danish: Pædiatrisk pJIA population
English: Formal studies of the potential effect of abatacept on human fertility have not been conducted.
Danish: Der er ikke udført formelle studier af abatacepts potentielle effekt på human fertilitet.
English: Subjects continued taking their current dose of MTX from the day of randomisation.
Danish: Forsøgspersonerne fortsatte med at tage deres planlagte dosis MTX fra randomiseringsdagen.
English: Steady state of abatacept was achieved by day 85 following the weekly body-weight-tiered subcutaneous abatacept dosing.
Danish: Steady state af abatacept blev opnået ved dag 85 efter den ugentlige kropsvægtbaserede abatacept subkutane dosering.
English: ORENCIA should not be used during pregnancy unless the clinical condition of the woman requires treatment with abatacept.
Danish: ORENCIA bør ikke anvendes under graviditet medmindre kvindens kliniske tilstand kræver behandling med abatacept.
English: The overall safety profile with respect to adverse reactions was similar between the two groups over the 24-month period.
Danish: Den overordnede sikkerhedsprofil for så vidt angår bivirkninger var sammenlignelig i de to grupper i løbet af 24måneders-perioden.
English: Administration of ORENCIA should be discontinued if a patient develops a serious infection.
Danish: Administration af ORENCIA skal seponeres, hvis patienten udvikler alvorlig infektion.
English: Uncommon Depression, anxiety, sleep disorder (including insomnia)
Danish: Depression, angst, søvnforstyrrelser (herunder insomni)
English: Full activation of T lymphocytes requires two signals provided by antigen presenting cells: recognition of a specific antigen by a T cell receptor (signal 1) and a second, costimulatory signal.
Danish: Fuld aktivering af T-lymfocytter kræver 2 signaler fra celler med antigener: genkendelse af et specifikt antigen af en T-cellereceptor (signal 1) og et andet co-stimulatorisk signal.
English: Talk to your doctor if you have any questions about giving yourself an injection.
Danish: Tal med lægen, hvis du har spørgsmål til, hvordan du selv tager indsprøjtningen.
English: How to use ORENCIA 4.
Danish: Sådan skal du bruge ORENCIA 4.
English: Response rates at the end of the short-term exposure are summarised in Table 9:
Danish: Responsrater ved slutningen af den kortvarige eksponering er opsummeret i tabel 9:
English: d After 6 months, patients were given the opportunity to enter an open-label study.
Danish: d Efter 6 måneder fik patienterne mulighed for at indgå i et åbent studie.
English: The safety of administering live vaccines to infants exposed to abatacept in utero is unknown.
Danish: Sikkerheden ved at administrere levende vacciner til spædbørn, der har været eksponeret for abatacept in utero, er ikke kendt.
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: The solution is clear, colourless to pale yellow with a pH of 6.8 to 7.4.
Danish: Væsken er klar, farveløs til lys gullig med en pH på 6,8 til 7,4.
English: You may use the same thigh for weekly injections, as long as each injection site is approximately 2.5 cm away from where you last injected.
Danish: Du kan godt bruge det samme lår til de ugentlige indsprøjtninger, så længe injektionsstedet er ca. 2,5 cm fra det sidste injektionssted.
English: Most recent:
Danish: Seneste behandling:
English: Some vaccines should not be given while you are receiving ORENCIA.
Danish: Nogle vacciner må ikke gives, mens du er i behandling med ORENCIA.
English: The medicinal product is for single use only.
Danish: Dette lægemiddel er udelukkende til engangsbrug.
English: This can cause joint damage.
Danish: Dette kan forårsage ledskader.
English: The significance of the higher incidence in the 2 to 5 year age cohort is unknown, taking into account the difference in sample size.
Danish: Betydningen af den højere forekomst i aldersgruppen 2-5 år er ikke kendt, hvor forskellen i populationsstørrelse er taget i betragtning.
English: Not assessed a day 169 Last Observation Carried Forward (LOCF) for patients treated in Period C b As observed
Danish: Ikke vurderet adag 169 Last Observation Carried Forward (LOCF) for patienter behandlet i periode C b Som observeret
English: Study V: abatacept or infliximab versus placebo
Danish: Studie V: abatacept eller infliximab versus placebo
English: Because immunogenicity analyses are product-specific, comparison of antibody rates with those from other products is not appropriate.
Danish: Analyser af immunogenicitet er produkt-specifikke, og derfor er sammenligning med antistof-tal for andre produkter ikke hensigtsmæssig.
English: Position the ClickJect Pen so you can see the viewing window and it's at a 90º angle to the injection site.
Danish: Placer ClickJect-pennen, så du kan se vinduet, og så pennen er placeret i en vinkel på 90º på injektionsstedet.
English: The systemic clearance was approximately 0.22 mL/h/kg.
Danish: Systemisk clearance var ca. 0,22 ml/h/kg.
English: ORENCIA can lower your body's ability to fight infection and the treatment can make you more likely to get infections or make any infection you have worse.
Danish: ORENCIA kan nedsætte kroppens evne til at bekæmpe infektion, og behandlingen kan øge risikoen for, at du får infektioner, eller forværre infektioner, du allerede har.
English: If you stop using ORENCIA The decision to stop using ORENCIA should be discussed with your doctor.
Danish: Hvis du holder op med at bruge ORENCIA Beslutningen om at holde op med ORENCIA skal tages i samråd med lægen.
English: Use your thumb to push the plunger down, pressing firmly until the plunger will go no further, and all of the medicine has been injected (Figure 6).
Danish: Brug tommelfingeren til at trykke på stemplet og tryk stemplet helt i bund, indtil al medicinen er blevet indsprøjtet (Figur 6).
English: At 10 mg/kg, the mean terminal half-life was 13.1 days, ranging from 8 to 25 days.
Danish: Ved 10 mg/kg var den gennemsnitlige halveringstid 13,1 dage, spændende fra 8 til 25 dage.
English: Other reactions potentially associated with hypersensitivity to the medicinal product, such as hypotension, urticaria, and dyspnea, that occurred within 24 hours of ORENCIA infusion, were uncommon.
Danish: Andre reaktioner, der kan være forbundet med overfølsomhed over for lægemidlet som hypotension, urticaria og dyspnø, som forekom inden for 24 timer efter infusion med ORENCIA, var ikke almindelige.
English: Patients who develop a new infection while undergoing treatment with ORENCIA should be monitored closely.
Danish: Patienter, som udvikler ny infektion under behandling med ORENCIA, skal overvåges omhyggeligt.
English: Inspect the syringe for obvious flaws, but don't remove the needle cover.
Danish: Kontroller injektionssprøjten for åbenlyse fejl, men fjern ikke kanylehætten.
English: Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which in addition to their underlying disease, could further predispose them to infections.
Danish: Mange af de alvorlige infektioner er forekommet hos patienter i samtidig behandling med immunsuppressiva, der ud over den underliggende sygdom kan prædisponere patienterne for infektioner.
English: No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving abatacept.
Danish: Der foreligger ingen data vedrørende sekundær infektionstransmission fra personer, der får levende vacciner, til patienter, der behandles med abatacept.
English: During the 12-week pre-filled pen period of the substudy, there were no deaths or related SAEs.
Danish: I sub-studiets periode på 12 uger med den fyldte pen optrådte der ingen dødsfald eller relaterede alvorlige bivirkninger.
English: Abatacept Abatacept Placebo Abatacept group in Period B
Danish: Abatacept Abatacept Placebo Abataceptgruppe i periode B
English: b 61% of patients were previously treated with TNF inhibitor.
Danish: b 61% af patienterne havde tidligere været behandlet med en TNF-hæmmer.
English: The respective values for ACR 50 and ACR 70 at 12 months and 24 months were consistent and similar for abatacept and adalimumab.
Danish: De respektive værdier for ACR-50 og ACR-70 ved 12 måneder og 24 måneder var konsistente og sammenlignelige for abatacept og adalimumab.
English: Step 5: Inject Your Dose of ORENCIA
Danish: TRIN 5: Indsprøjt din dosis af ORENCIA
English: Total Sharp score Erosion score JSN score a Based on non-parametric analysis.
Danish: TS-score Erosionsscore JSN-score a Baseret på non-parametrisk analyse.
English: Keep this card with you for 3 months after the last ORENCIA dose, since side effects may occur a long time after your last dose of ORENCIA.
Danish: Dette kort skal du bære på dig i 3 måneder efter den sidste ORENCIA-dosis, da der kan forekomme bivirkninger længe efter, du har fået den sidste ORENCIA-dosis.
English: Live vaccines should not be given concurrently with abatacept or within 3 months of its discontinuation.
Danish: Levende vacciner bør ikke gives samtidig med abatacept eller inden for 3 måneder efter seponering.
English: Of the 54 patients withdrawn from ORENCIA during the doubleblind period for up to 6 months, none had an infusion reaction upon re-initiation of ORENCIA.
Danish: Af de 54 patienter, hvor behandlingen med ORENCIA blev seponeret i op til 6 måneder i den dobbeltblinde periode fik ingen en infusionsreaktion ved genoptagelse af behandlingen med ORENCIA.
English: Abatacept is a fusion protein that consists of the extracellular domain of human cytotoxic Tlymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1).
Danish: Abatacept er et fusionsprotein bestående af det ekstracellulære domæne af humant cytotoksisk Tlymfocyt-associeret antigen 4 (CTLA-4) forbundet med en modificeret Fc-del af humant immunglobulin G1 (IgG1).
English: The occurrence of anaphylaxis remained rare during the double blind and the cumulative period.
Danish: Forekomsten af anafylaksi forblev sjælden under de dobbeltblinde og den samlede periode.
English: Step 6: After the Injection
Danish: TRIN 6: Efter injektionen
English: Having an infection could put you at risk of serious side effects from ORENCIA.
Danish: Hvis du har en infektion, er der risiko for at få alvorlige bivirkninger af ORENCIA.
English: In the substudy of study VI, patients who had achieved remission at 2 years (DAS 28 ESR < 2.6) and after at least 1 year of treatment with abatacept in study VI were eligible to enter a substudy.
Danish: I et substudie til studie VI blev patienter, som havde opnået remission ved år 2 (DAS 28 ESR < 2,6) og efter mindst 1 års behandling med abatacept i studie VI, fundet egnet til at indgå i et substudie.
English: Look closely to make sure that the amount of liquid in the pre-filled syringe is at or just above the fill line for your prescribed dose:
Danish: Se nøje for at sikre dig at mængden af væske i den fyldte injektionssprøjte er ved eller lige over fyldelinjen for din ordinerede dosis.
English: If you received ORENCIA during your pregnancy, your baby may have a higher risk for getting an infection.
Danish: Hvis du fik ORENCIA under graviditeten, kan din baby have en øget risiko for at få en infektion.
English: Proportion of patients with ACR responses at week 24 in studies PsA-I and PsA-II
Danish: Procentdel af patienter med ACR-respons ved uge 24 i studierne PsA-I og PsA-II
English: Remove one Pen from the refrigerator and let it rest at room temperature (about 25°C) for 30 minutes.
Danish: Tag en pen ud af køleskabet og lad den ligge ved stuetemperatur (ca. 25°C) i 30 minutter.
English: • Show this card to any doctor involved in your treatment.
Danish: • Vis kortet til de læger, du er i behandling hos.
English: Blood glucose testing
Danish: Test af blod-glucose
English: In addition, serum levels of matrix metalloproteinase-3, which produces cartilage destruction and tissue remodelling, were decreased.
Danish: Derudover faldt serumniveauer af matrix metalloproteinase-3, som inducerer nedbrydning af brusk og remodellering af væv.
English: In this case, you will get training on how to inject ORENCIA yourself.
Danish: I dette tilfælde vil du blive undervist i, hvordan du selv tager ORENCIA.
English: Two patients (2/117, 1.7%) using the SC prefilled pen experienced local injection site reactions.
Danish: To patienter (2/117, 1,7%), som brugte den fyldte pen s.c., oplevede lokale reaktioner på injektionsstedet.
English: This was mostly due to non-serious upper respiratory tract infections in the 2 to 5 year age cohort.
Danish: Dette skyldtes først og fremmest ikke-alvorlige infektioner i de øvre luftveje i aldersgruppen 2-5 år.
English: Studies in rats exposed to abatacept have shown immune system abnormalities including a low incidence of infections leading to death (juvenile rats).
Danish: Studier med rotter, der blev eksponeret for abatacept, har vist immunsystemabnormiteter herunder en lav forekomst af infektioner medførende død (unge rotter).
English: Health-related quality of life was assessed by the SF-36 questionnaire at 6 months in studies I, II, and III and at 12 months in studies I and II.
Danish: Helbredsrelateret livskvalitet blev vurderet ved SF-36-spørgeskemaet ved 6 måneder i studie I, II og III og ved 12 måneder i studie I og II.
English: Samples with confirmed binding activity to CTLA-4 were assessed for the presence of neutralizing antibodies.
Danish: Prøver med bekræftet bindingsaktivitet til CTLA-4 blev vurderet for tilstedeværelse af neutraliserende antistoffer.
English: Study VII: Safety of abatacept in patients with or without washout of previous TNF-inhibitor therapy
Danish: Studie VII: Sikkerhed ved abatacept hos patienter med eller uden udvaskning af tidligere TNFhæmmer
English: Placebo group in Period B
Danish: Placebogruppe i periode B
English: Two serious infections (varicella and sepsis) were reported during the initial 4 months of treatment with abatacept.
Danish: To alvorlige infektioner (varicella og sepsis) blev rapporteret under den initiale 4 måneders behandling med abatacept.
English: - Any unused portion in the vials must be immediately discarded in accordance with local requirements.
Danish: - Eventuelt ubrugt infusionsvæske i hætteglasset skal straks bortskaffes i overensstemmelse med lokale krav.
English: Their pJIA subtypes at disease onset were: oligoarticular (16%), polyarticular (64%; 20% of the total were rheumatoid factor positive), and systemic (20%).
Danish: Deres pJIAundertyper ved sygdomsdebut var: oligoartikulær (16%), polyartikulær (64%; 20% af det samlede antal var reumafaktor-positive) og systemisk (20%).
English: Check with your doctor before you are given any vaccines.
Danish: Rådfør dig med lægen, inden du bliver vaccineret.
English: The rate is consistent with previous experience, and there was no effect of immunogenicity on pharmacokinetics, safety, or efficacy.
Danish: Forekomsten svarer til tidligere erfaringer, og immunogeniciteten havde ikke nogen effekt på farmakokinetik, sikkerhed eller virkning.
English: Your doctor may also do tests to examine your blood values.
Danish: Lægen vil muligvis tage blodprøver for at kontrollere dine blodværdier.
English: Age and gender (when corrected for body weight) did not affect clearance.
Danish: Alder og køn (korrigeret for kropsvægt) påvirkede ikke clearance.
English: Your baby may be at risk of severe infection caused by “live vaccines” for 14 weeks since your last ORENCIA administration.
Danish: Der er en risiko for, at din baby kan få en alvorlig infektion forårsaget af en ”levende vaccine” i 14 uger efter din sidste behandling med ORENCIA.
English: The Marketing Authorisation Holder (MAH) shall ensure that in each Member State where ORENCIA is marketed, all patients who are expected to use ORENCIA have access to the Patient Alert Card (provided within each medicine pack).
Danish: Indehaveren af markedsføringstilladelsen skal sikre sig, at alle patienter, som forventes at bruge ORENCIA, i alle medlemsstater, hvor ORENCIA er markedsført, skal have adgang til advarselskortet til patienter (der udleveres sammen med medicinpakningen).
English: Period A was a 4-month open-label lead-in designed to induce an ACR Pedi 30 response.
Danish: Periode A var en 4 måneders åben indkøringsfase designet til at forårsage en ACR Pedi 30-respons.
English: Month 12 41%‡
Danish: Måned 12 41%‡
English: if you recently had a vaccination or are planning to have one, tell your doctor.
Danish: hvis du for nylig er vaccineret, eller du planlægger vaccination, skal du fortælle det til lægen.
English: SC bioavailability (F) increased by 28% and the absorption rate constant (KA) was higher in pJIA patients than RA patients.
Danish: S.c. biotilgængelighed (F) blev øget med 28% og absorptionshastighedskonstanten (KA) var højere hos pJIA patienter end hos RA patienter.
English: Don't touch the needle or let it touch any surfaces.
Danish: Lad være med at røre kanylen og undgå at den rører andre overflader.
English: In addition, inflammation of the thyroid and pancreas was frequently seen in both juvenile and adult rats exposed to abatacept.
Danish: Derudover blev der hyppigt observeret inflammation i skjoldbruskkirtlen og bugspytkirtlen hos både unge og voksne rotter, der blev eksponeret for abatacept.
English: e After 6 months, patients were given the opportunity to enter into an open-label study.
Danish: e Efter 6 måneder fik patienterne mulighed for at indgå i et åbent studie.
English: Proportion (%) of polyarticular JIA patients with ACRP responses or inactive disease at end of short-term period (4 months) Ages 2 to 17 years n=219
Danish: Andel (%) af polyartikulære JIA-patienter med ACRP-respons eller inaktiv sygdom ved slutningen af den kortvarige periode (4 måneder) Alder 2 til 17 år n=219
English: Slow down the damage to your bones and joints.
Danish: At nedsætte skaderne på dine knogler og led.
English: Effects on the immune system
Danish: Påvirkning af immunsystemet
English: Clinical responses in controlled trials Percent of patients
Danish: Klinisk respons i kontrollerede studier Procentdel af patienter
English: Mean estimates for systemic clearance (0.28 mL/h/kg), volume of distribution (0.11 L/kg), and terminal half-life (14.3 days) were comparable between subcutaneous and intravenous administration.
Danish: Middelestimater for systemisk clearance (0,28 ml/t/kg), fordelingsvolumen (0,11 l/kg) og terminal halveringstid (14,3 dage) var sammenlignelige mellem subkutan og intravenøs administration.
English: a DAS28-defined remission (DAS28-CRP <2.6) b SDAI criterion (SDAI ≤ 3.3)
Danish: a DAS28-defineret remission (DAS28-CRP <2,6) b SDAI-kriterium (SDAI ≤ 3,3)
English: 1,000 mg a Approximating 10 mg/kg.
Danish: 1.000 mg a Ca. 10 mg/kg.
English: The potential clinical relevance of neutralizing antibody formation is not known.
Danish: Den potentielle kliniske relevans af dannelsen af neutraliserende antistoffer er ukendt.
English: Immunogenicity and safety of abatacept upon withdrawal and restart of treatment
Danish: Abatacepts immunogenicitet og sikkerhed efter seponering og genoptagelse af behandling
English: Subjects entering the long term extension after 1 year of double blind treatment all received abatacept treatment and radiographic progression was investigated through year 5.
Danish: Forsøgspersoner, som deltog i den lange forlængelse efter 1 års dobbeltblind behandling, fik alle abatacept og radiografisk progression blev undersøgt gennem 5 år.
English: The ACR responses in study V were consistent with the DAS28 score.
Danish: ACR-respons i studie V var konsistent med hensyn til DAS28-scoren.
English: Reductions in serum TNFα were also observed.
Danish: Der sås ligeledes fald i serum-TNFα.
English: ORENCIA is used to: slow down the damage to your joints improve your physical function
Danish: ORENCIA anvendes til: at forsinke skaden på dine led at forbedre din fysiske funktionsevne
English: c Patients who had less than 20% improvement in tender or swollen joint counts at Week 16 met escape criteria and were considered non-responders.
Danish: c Patienter som havde mindre end 20% forbedring i ømme eller hævede led ved uge 16 mødte kriterierne for at udgå og blev betragtet som ikke-responderende.
English: How often ORENCIA is given to you
Danish: Hvor ofte indgives ORENCIA
English: All injection site reactions were described as mild to moderate (hematoma, pruritus, or erythema) and generally did not necessitate drug discontinuation.
Danish: Alle reaktioner på injektionsstedet blev beskrevet som lette til moderate (hæmatom, pruritus eller erythem) og krævede generelt ikke seponering af lægemidlet.
English: Studies I, II, III, V, and VI required patients to have at least 12 tender and 10 swollen joints at randomisation.
Danish: I studie I, II, III, V og VI skulle patienterne have mindst 12 ømme og 10 hævede led ved randomisering.
English: Don't try to self-inject until you are sure that you understand how to prepare and give the injection.
Danish: Du må ikke forsøge selv at indsprøjte ORENCIA, før du er sikker på, at du forstår, hvordan injektionen klargøres og indgives.
English: Patients with known malignancies were not included in these clinical trials.
Danish: Patienter med kendte maligniteter kunne ikke deltage i disse kliniske studier.
English: The relevance of these findings to the clinical use of abatacept is unknown.
Danish: Relevansen af disse fund for den kliniske anvendelse af abatacept kendes ikke.
English: Structural response
Danish: Strukturel respons
English: It is unknown whether abatacept is excreted in human milk.
Danish: Det vides ikke, om abatacept udskilles i human mælk.
English: In this study, the steady-state concentrations of abatacept were dose-related.
Danish: I dette studie var steady-state koncentrationerne for abatacept dosis-relaterede.
English: No dose recommendations can be made.
Danish: Der kan ikke angives dosisanbefalinger.
English: The median duration of abatacept treatment in Period C was 1815 days (range 57-2,415 days; nearly 61 months).
Danish: Den gennemsnitlige varighed for abatacept-behandlingen i periode C var 1.815 dage (med et spænd på 57-2.415 dage; næsten 61 måneder).
English: Patients treated with abatacept subcutaneously also achieved similar ACR 50 and 70 responses as those patients receiving abatacept intravenously at 6 months.
Danish: Patienter, der blev behandlet subkutant med abatacept, opnåede samme ACR 50- og 70-respons som de patienter, der modtog abatacept intravenøst i 6 måneder.
English: Clinical responses in controlled trials Percent of patients Intravenous administration
Danish: Klinisk respons i kontrollerede studier Procentdel af patienter Intravenøs administration
English: However, you and your doctor may decide that you can inject ORENCIA yourself.
Danish: Du og din læge kan dog beslutte, at du selv tager ORENCIA.