FrancophonIA/ELRC3.0 huggingface dataset:
English: Veyvondi was shown to be effective in treating bleeding episodes in patients with von Willebrand disease.
Danish: Det er påvist, at Veyvondi er effektivt til behandling af blødningsepisoder hos patienter med von Willebrands sygdom.
English: For the full list of side effects of Veyvondi, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Veyvondi fremgår af indlægssedlen.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Veyvondi have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Veyvondi.
English: How is Veyvondi used?
Danish: Hvordan anvendes Veyvondi?
English: What benefits of Veyvondi have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Veyvondi?
English: How does Veyvondi work?
Danish: Hvordan virker Veyvondi?
English: Press & Hold
Danish: Tryk & Hold
English: Improve your physical function and your ability to do normal daily activities.
Danish: At forbedre din fysiske funktion og din evne til at udføre almindelige daglige aktiviteter.
English: Some of these infections have been fatal.
Danish: Nogle af disse infektioner har været dødelige.
English: Most of these reactions were mild to moderate.
Danish: De fleste af reaktionerne var milde til moderate.
English: WAIT until blue indicator stops moving
Danish: VENT indtil den blå indikator ikke bevæger sig
English: Abatacept is the first selective co-stimulation modulator.
Danish: Abatacept er den første, selektive co-stimulerende modulator.
English: You may see a small air bubble.
Danish: Du kan muligvis se en lille luftboble.
English: The response at year 1 in the abatacept group was maintained through year 2.
Danish: Responset ved år 1 i abatacept-gruppen blev opretholdt gennem år 2.
English: E. Wash your hands thoroughly with soap and warm water.
Danish: E. Vask hænderne grundigt med sæbe og varmt vand.
English: RA is usually a chronic (long-term), progressive disease.
Danish: RA er sædvanligvis en kronisk (permanent) progressiv sygdom.
English: After that you will receive a dose every 4 weeks.
Danish: Herefter får du en dosis hver 4. uge.
English: There is no need to remove the air bubble.
Danish: Det er ikke nødvendigt at fjerne luftboblen.
English: The ACRP responses and inactive disease results were maintained through 2 years.
Danish: ACRP responser og inaktive sygdomsresultater blev bibeholdt gennem 2 år.
English: You do not need to remove it.
Danish: Du behøver ikke fjerne den.
English: Blue Indicator
Danish: Blå indikator
English: The Pen automatically delivers the medicine.
Danish: Pennen frigiver automatisk medicinen.
English: Long-term extension period
Danish: Langvarig forlængelsesperiode
English: Safety information related to the pharmacological class
Danish: Sikkerhedsoplysninger relateret til den farmakologiske klasse
English: Non-clinical studies relevant for use in the paediatric population
Danish: Ikke-kliniske studier, der er relevante for brug i den pædiatriske population
English: However, in some, RA may progress rapidly and yet other people may have RA for a limited period of time and then enter a period of remission.
Danish: Hos nogle kan RA dog udvikle sig hurtigt, og atter andre kan have RA i en begrænset periode, hvorefter de oplever en periode med bedring.
English: Allergic reactions may occur after the use of ORENCIA.
Danish: Der kan forekomme allergiske reaktioner efter brug af ORENCIA.
English: It is very important to use ORENCIA exactly as prescribed by your doctor.
Danish: Det er meget vigtigt at tage ORENCIA præcist som anvist af lægen.
English: Press button, HOLD for 15 seconds AND watch window.
Danish: Tryk på knappen, HOLD i 15 sekunder OG hold øje med vinduet.
English: End of Period A (day 113)
Danish: Slutning af periode A (dag 113)
English: However, the number of patients that developed antibodies was too limited to make a definitive assessment.
Danish: Antallet af patienter der udviklede antistoffer var imidlertid for begrænset til, at vurderingen er definitiv.
English: Twenty-two of 48 evaluable patients showed significant neutralizing activity.
Danish: 22 ud af 48 evaluérbare patienter havde signifikant neutraliserende aktivitet.
English: No systemic hypersensitivity reactions were reported.
Danish: Ingen systemiske overfølsomhedsreaktioner blev rapporteret.
English: d Reduction in HAQ-DI of ≥ 0.3 units from baseline.
Danish: d Reduktion i HAQ-DI på ≥ 0,3 enheder fra baseline.
English: The most frequently reported event with abatacept (1-2%) was dizziness.
Danish: Den hyppigst rapporterede hændelse med abatacept (1-2%) var svimmelhed.
English: Reduce the signs and symptoms of your disease.
Danish: At reducere tegn og symptomer på din sygdom.
English: The relevance of these results to humans is unknown.
Danish: Relevansen af disse resultater hos mennesker er ukendt.
English: Date of first authorisation: 21 May 2007 Date of latest renewal: 21 May 2012
Danish: Dato for første markedsføringstilladelse: 21. maj 2007 Dato for seneste fornyelse: 21. maj 2012
English: Check the Pen for damage.
Danish: Undersøg pennen for skader.
English: Certain vaccinations may cause infections from the vaccine.
Danish: Nogle vaccinationer kan forårsage infektioner, der skyldes vaccinen.
English: It is normal to see an air bubble, and there is no reason to remove it. All contents of the syringe should be injected.
Danish: Det er normalt at kunne se en luftboble, og det er ikke nødvendigt at fjerne den. Hele indholdet i injektionssprøjten skal indsprøjtes.
English: The final concentration of abatacept in the bag or bottle will depend upon the amount of active substance added, but will be no more than 10 mg/mL.
Danish: Den endelige abatacept-koncentration i posen eller flasken afhænger af den mængde aktivt stof, der tilsættes, men vil ikke være mere end 10 mg/ml.
English: Safety and structural damage assessments were conducted at one and two years.
Danish: Vurdering af sikkerhed og strukturel skade blev udført ved år et og to.
English: Health-related outcomes and quality of life
Danish: Helbredsrelaterede endepunkter og livskvalitet
English: This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 1,7% af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: There are no adequate data from use of abatacept in pregnant women.
Danish: Der foreligger ikke tilstrækkelige data om brug af abatacept hos gravide kvinder.
English: In most people, joint symptoms develop gradually over several years.
Danish: Hos de fleste vil der gradvist over en årrække udvikles ledsymptomer.
English: Flange extender
Danish: Udvidet flange
English: Non-responder in Period A
Danish: Patienter uden respons i periode A
English: This procedure is referred to as an infusion.
Danish: Proceduren kaldes en infusion.
English: It is used in combination with a medicine called methotrexate.
Danish: Det bruges i kombination med et lægemiddel, der kaldes methotrexat.
English: Proportion of patients with a clinically meaningful improvementd
Danish: Andel af patienter med en klinisk signifikant forbedringd
English: The safety of ORENCIA in individuals with latent tuberculosis is unknown.
Danish: ORENCIAs sikkerhed hos personer med latent tuberkulose er ikke kendt.
English: Mean Improvement from Baseline
Danish: Gennemsnitlig forbedring fra baseline
English: Study SC-I
Danish: Studie SC-I
English: Wash your hands well with soap and water to prepare for injection.
Danish: Vask hænderne grundigt med vand og sæbe for at gøre klar til injektion.
English: Studies in adult mice and monkeys have not demonstrated similar findings.
Danish: Studier med voksne mus og aber har ikke vist lignende fund.
English: Improvement in physical function in controlled trials Methotrexate-Naive Inadequate response to Methotrexate
Danish: Forbedring i fysisk funktion i kontrollerede studier Methotrexat-naive Utilstrækkeligt respons på methotrexat
English: Similar efficacy was observed in these patients and in younger patients.
Danish: Der sås samme effekt i denne patientgruppe som hos yngre patienter.
English: Study V continued for an additional 6 months with the abatacept and infliximab groups only.
Danish: Studie V fortsatte i yderligere 6 måneder med kun abatacept- og infliximabgruppen.
English: Of the 219 patients treated, 205 completed the short-term period and 200 entered the ongoing longterm extension period.
Danish: Af de 219 behandlede patienter gennemførte 205 den kortvarige periode og 200 indgik i den igangværende langvarige forlængelsesperiode.
English: ORENCIA can cause serious side effects, which may need treatment.
Danish: ORENCIA kan forårsage alvorlige bivirkninger, som det kan være nødvendigt at behandle.
English: Study IV did not require any specific number of tender or swollen joints.
Danish: I studie IV krævedes ikke et specifikt antal ømme eller hævede led.
English: Your doctor will advise you on suitable methods.
Danish: Lægen vil rådgive dig om egnede præventionsmetoder.
English: Activation Button (BLUE)
Danish: Aktiveringsknap (BLÅ)
English: If you do not respond well enough to these medicines, you may be given ORENCIA to:
Danish: Hvis du ikke responderer tilstrækkeligt på disse lægemidler, kan du få ordineret ORENCIA for:
English: Patient's Name: ____________________
Danish: Patientens navn: ____________________
English: Inject: push the plunger with your thumb as far as it will go.
Danish: Indsprøjt: tryk på stemplet med din tommelfinger så langt som det kan komme.
English: ORENCIA is given to you into a vein, usually in your arm, over a period of 30 minutes.
Danish: ORENCIA indgives i en vene, sædvanligvis i armen, over en periode på 30 minutter.
English: Always handle the ORENCIA syringe carefully, especially when you are around other people, and children.
Danish: Du skal altid håndtere ORENCIA-injektionssprøjten med forsigtighed, især når du er sammen med andre mennesker herunder børn.
English: OTHER SPECIAL WARNING(S), IF NECESSARY 8.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER 8.
English: ORENCIA has not been studied in these patient populations.
Danish: ORENCIA er ikke undersøgt i disse patientpopulationer.
English: It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had TB.
Danish: Det er vigtigt, at du fortæller din læge, hvis du har eller tidligere har haft tuberkulose, eller hvis du har været i tæt kontakt med nogen, som har tuberkulose.
English: Combination with other medicinal products that affect the immune system and with vaccinations
Danish: Kombination med andre lægemidler, der kan påvirke immunsystemet og med vaccinationer
English: Check the expiry date printed on the label.
Danish: Kontroller udløbsdatoen, som er trykt på etiketten.
English: Mean radiographic changes over 12 months in study II
Danish: Gennemsnitlige radiografiske forandringer over 12 måneder i studie II
English: Keep track of your next dose.
Danish: Du skal holde styr på din næste dosis.
English: Component of a multipack, can't be sold separately.
Danish: Del af multipakning, kan ikke sælges enkeltvist.
English: Read carefully.
Danish: Læs den omhyggeligt.
English: During Periods A, B, and C, acute infusion-related reactions occurred at a frequency of 4%, 2%, and 4%, respectively, and were consistent with the types of reactions reported in adults.
Danish: I perioderne A, B og C forekom akutte infusionsrelaterede reaktioner med en hyppighed på henholdsvis 4%, 2% og 4% og det var den samme type reaktioner, som blev rapporteret hos voksne.
English: The exposure adjusted incidence rate (expressed per 100 person-years) remained stable over the treatment duration.
Danish: Den eksponeringsjusterede forekomst (angivet som 100 personår) forblev stabil i behandlingsperioden.
English: BEFORE YOU BEGIN
Danish: FØR DU BEGYNDER
English: Period Cb (day 1765)
Danish: Periode Cb (dag 1.765)
English: Abdomen, avoid 5 cm around navel
Danish: Mave, undgå området 5 cm rundt om navlen
English: ACR30 65 ACR50 50 ACR70 28 ACR90 13 Inactive disease
Danish: ACR30 65 ACR50 50 ACR70 28 ACR90 13 Inaktiv sygdom
English: You will hear a click as the injection begins.
Danish: Der lyder et klik, når injektionen begynder.
English: This alert card contains important safety information that you need to be aware of before you are given ORENCIA and during treatment with ORENCIA.
Danish: Dette advarselskort indeholder vigtige informationer om sikkerhed, som du skal være opmærksom på, inden du får ORENCIA, og mens du er i behandling med ORENCIA.
English: Consequently, these infants may be at increased risk of infection.
Danish: Derfor kan disse spædbørn have en øget risiko for infektioner.
English: 30 Minutes
Danish: 30 Minutter
English: Complete ALL steps to deliver your full dose of the medicine
Danish: Færdiggør ALLE trin for at indgive den fulde dosis af medicinen
English: ORENCIA contains the active substance abatacept, a protein produced in cell cultures.
Danish: ORENCIA indeholder det aktive stof abatacept, et protein, der dannes i cellekulturer.
English: If you have active psoriatic arthritis you will first be given other medicines.
Danish: Hvis du har aktiv psoriasisgigt vil du først blive behandlet med andre lægemidler.
English: To be administered as a 30-minute intravenous infusion at the dose specified in Table 1.
Danish: Skal administreres som en 30-minutters intravenøs infusion i den dosis, som er specificeret i Tabel 1.
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA24
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, selektive immunsuppressiva, ATC-kode: L04AA24
English: If you do not respond well enough to these medicines, you may be given ORENCIA to: Reduce the signs and symptoms of your disease.
Danish: Hvis du ikke responderer tilstrækkeligt på disse lægemidler, kan du få ordineret ORENCIA for: At reducere tegn og symptomer på din sygdom.
English: However, for microbiological reasons, it is to be used immediately.
Danish: Den bør dog af mikrobiologiske årsager anvendes straks.
English: There was a significant improvement of DAS in studies II, III, V, and VI as compared to placebo or comparator.
Danish: Der var signifikant forbedring af DAS i studie II, III, V og VI sammenlignet med placebo eller komparator.
English: Once you remove it from your skin, the transparent tip will lock over the needle.
Danish: Når du har fjernet den fra huden, vil den gennemsigtige spids låses over kanylen.
English: ORENCIA can be used by adults over 65 with no change in dose.
Danish: ORENCIA kan anvendes af voksne over 65 år uden ændring i dosis.
English: Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
Danish: Regelmæssig undersøgelse af huden anbefales for alle patienter, men især for patienter med risikofaktorer for hudcancer.
English: After proper training, you can give the injection to yourself, or it can be given by another person, for example a family member or friend.
Danish: Efter passende undervisning kan du selv tage indsprøjtningen, eller en anden person kan give injektionen, f.eks. et familiemedlem eller en ven.
English: For full-dose delivery, hold the Pre-filled Pen in place for 15 seconds AND wait until blue indicator stops moving in window.
Danish: For at få den fulde dosis skal du holde pennen nede i 15 sekunder OG vente, indtil den blå indikator i vinduet ikke længere bevæger sig.
English: It is likely that the increased susceptibility to opportunistic infections observed in juvenile rats is associated with the exposure to abatacept before development of memory responses.
Danish: Det er sandsynligt, at den øgede følsomhed over for opportunistiske infektioner, der er observeret hos unge rotter, er associeret med eksponering for abatacept inden udvikling af memory-respons.
English: Choose a different injection site for each new injection.
Danish: Vælg et nyt injektionssted til hver injektion.
English: Disease activity was also assessed using the Disease Activity Score 28.
Danish: Sygdomsaktivitet blev også vurderet ved DAS28 (Disease Activity Score 28).
English: Inadequate response to MTX
Danish: Utilstrækkeligt respons på MTX
English: Further improvement was observed at 12 months with abatacept.
Danish: Der blev observeret yderligere forbedring efter 12 måneders behandling med abatacept.
English: Recommended dose in adults
Danish: Anbefalet dosis til voksne
English: PREPARE FOR INJECTION
Danish: GØR KLAR TIL INJEKTION
English: Abatacept was shown to cross the placenta in rats and rabbits.
Danish: Det er vist, at abatacept passerer placenta hos rotter og kaniner.
English: Study SC-I: Pre-filled pen sub-study
Danish: Studie SC-I: Fyldt pen sub-studie
English: The clinical significance of this observation is unknown (see section 5.3).
Danish: Den kliniske betydning af denne observation kendes ikke (se pkt.
English: The type of pre-filled syringe you receive depends on the dose prescribed by your doctor.
Danish: Typen af fyldt injektionssprøjte du modtager, afhænger af den dosis din læge udskriver.
English: The active substance is abatacept.
Danish: Aktivt stof: abatacept.
English: if you have a severe or uncontrolled infection, do not start treatment with ORENCIA.
Danish: hvis du har en alvorlig eller ukontrolleret infektion, må du ikke starte behandling med ORENCIA.
English: After 1 year of treatment, the maintenance of remission was assessed by the relapse of the disease.
Danish: Efter 1 års behandling blev fastholdelse af remission vurderet ud fra sygdomsrelaps.
English: Study SC-II: abatacept versus adalimumab
Danish: Studie SC-II: abatacept versus adalimumab
English: - You must not be treated with ORENCIA if you have severe infection.
Danish: - Du må ikke behandles med ORENCIA, hvis du har en alvorlig infektion.
English: This means, even if you're on treatment, whether or not you're still having symptoms, RA could be continuing to damage your joints.
Danish: Det betyder, at selvom du er i behandling, og hvad enten du har symptomer eller ej, så kan leddegigten fortsætte med at beskadige dine led.
English: 15 Seconds
Danish: 15 Sekunder
English: The pen should not be shaken.
Danish: Pennen bør ikke rystes.
English: N/A Proportion of randomised patients in remission at 12 months and at 18 months (6 months of complete drug withdrawal)
Danish: N/A Forholdet mellem randomiserede patienter i remission ved 12 måneder og ved 18 måneder (6 måneders komplet lægemiddelseponering)
English: Confirm: after a complete injection, the needle guard will cover the needle and you may hear a click.
Danish: Bekræft: efter en færdiggjort injektion vil beskyttelseshætten dække kanylen og du kan høre et klik.
English: Treatment with ORENCIA should not be initiated in patients with active infections until infections are controlled.
Danish: Behandling med ORENCIA bør ikke påbegyndes hos patienter med aktive infektioner, før infektionerne er under kontrol.
English: Patients continued abatacept treatment in an ongoing open-label extension, which assessed long-term safety and efficacy for an additional 20 months.
Danish: Patienterne fortsatte med abataceptbehandling i en igangværende åben forlængelse, der vurderede langvarig sikkerhed og effekt i yderligere 20 måneder.
English: Remission rates at end of drug treatment and drug withdrawal phases in study SC-III
Danish: Remissionsrater ved afslutning af behandling og seponeringsfasen i studie SC-III
English: c Major clinical response is defined as achieving an ACR 70 response for a continuous 6-month period.
Danish: c Større klinisk respons defineres som opnåelse af ACR 70-respons over en 6-måneders periode.
English: Look at the liquid in the syringe (Figure 2).
Danish: Kig på væsken i injektionssprøjten (Figur 2).
English: As in study SC-I, there was no effect of immunogenicity on safety or efficacy.
Danish: Lige som i studie SC-I havde immunogeniciteten ikke nogen effekt på sikkerhed eller virkning.
English: The primary endpoint for both PsA-I and PsA-II was the proportion of patients achieving ACR 20 response at Week 24 (day 169).
Danish: Det primære endepunkt for både PsA-I og PsA-II var andelen af patienter som fik ACR 20-respons ved uge 24 (dag 169).
English: End of Period Ba (day 169)
Danish: Slutning af periode Ba (dag 169)
English: No increase of tuberculosis was observed in the pivotal placebo-controlled studies; however, all ORENCIA patients were screened for tuberculosis.
Danish: Der er ikke observeret øget forekomst af tuberkulose i de større, placebo-kontrollerede studier; alle ORENCIA-patienter blev imidlertid screenet for tuberkulose.
English: if you have cancer, your doctor will decide if you can still be given ORENCIA.
Danish: hvis du har kræft, vil din læge beslutte, hvorvidt du kan fortsætte med ORENCIA.
English: ORENCIA increases the risk of getting infections.
Danish: ORENCIA øger risikoen for infektioner.
English: Let your skin dry before injecting.
Danish: Lad huden tørre inden indsprøjtningen.
English: Important instructions for use Please read these instructions carefully and follow them step by step.
Danish: Vigtig brugervejledning Læs denne vejledning grundigt og følg den trin for trin.
English: HAQc Disability Index
Danish: HAQc Handicapindex
English: ORENCIA, in combination with methotrexate, is indicated for:
Danish: ORENCIA er i kombination med methotrexat indiceret til:
English: If the dose is missed by more than three days, the patient should be instructed when to take the next dose based on medical judgment (condition of the patient, status of disease activity, etc).
Danish: Hvis der er gået mere end tre dage siden den planlagte dato, bør patienten informeres om, hvornår den næste dosis bør tages baseret på en klinisk vurdering (patientens tilstand, status for sygdomsaktivitet etc.).
English: INJECT YOUR DOSE
Danish: INDSPRØJT DIN DOSIS
English: Doctor's Phone: ____________________
Danish: Lægens telefonnummer: ______________
English: Abatacept selectively inhibits this costimulatory pathway by specifically binding to CD80 and CD86.
Danish: Abatacept hæmmer selektivt denne co-stimulation ved specifikt at bindes til CD80 og CD86.
English: The potential role of abatacept in the development of malignancies, including lymphoma, in humans is unknown.
Danish: Abatacepts potentielle rolle i udviklingen af maligniteter inklusive lymfomer hos mennesker er ukendt.
English: Data were analysed in an as-observed analysis using mean change in total score from the previous annual visit.
Danish: Data blev analyseret i en ”som observeret” analyse ved brug af gennemsnitlig ændring i samlet score fra det foregående årlige besøg.
English: Doctor's Name: ____________________
Danish: Lægens navn: ______________________
English: Abatacept may cross the placenta into the serum of infants born to women treated with abatacept during pregnancy.
Danish: Abatacept kan passere placenta og kan findes i serum hos spædbørn født af kvinder, der er blevet behandlet med abatacept under graviditeten.
English: Long-term safety data in 2 to 5 year age cohort with pJIA was limited, but the existing evidence did not reveal any new safety concern in this younger paediatric population.
Danish: Langtidssikkerhedsdata i aldersgruppen 2-5 år med pJIA var begrænset, men den eksisterende dokumentation afslørede ikke nogle nye sikkerhedsmæssige bekymringer hos denne yngre pædiatriske population.
English: 15, 29, and then every 28 days thereafter.
Danish: på dag 1, 15, 29 og derefter hver 28. dag.
English: In a one-year toxicity study in cynomolgus monkeys, abatacept was not associated with any significant toxicity.
Danish: I et 1-årigt toksicitetsstudie med cynomolgus-aber var abatacept ikke forbundet med signifikant toksicitet.
English: Anaphylaxis or anaphylactoid reactions can occur after the first infusion and can be life-threatening.
Danish: Anafylaksi eller anafylaktoide reaktioner kan forekomme efter den første infusion og kan være livstruende.