FrancophonIA/ELRC3.0 huggingface dataset:
English: Most events were not serious, were mild to moderate in intensity, and did not recur.
Danish: De fleste reaktioner var ikke alvorlige, milde til moderate og opstod ikke igen.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 June 2011
Danish: Dato for første markedsføringstilladelse: 17. juni 2011
English: Please make sure you have this card with you at all times and a list of all your other medicines with you at any visit to a healthcare professional.
Danish: Sørg for altid at have dette kort på dig samt en liste over al den medicin, som du anvender, ved ethvert besøg til lægen eller andet sundhedspersonale.
English: Therefore, preclinical studies conducted with abatacept have been used to support the safety of belatacept in addition to the studies conducted with belatacept.
Danish: Derfor er de prækliniske studier, der er foretaget med abatacept, blevet anvendt til at understøtte belatacepts sikkerhed ud over de studier, der er foretaget med belatacept.
English: The diluted solution must be administered as an intravenous infusion at a relatively constant rate over 30 minutes.
Danish: Den fortyndede opløsning skal administreres som intravenøs infusion med en relativ konstant hastighed i løbet af 30 minutter.
English: Table 4: Infections occurring by treatment group (%)
Danish: Tabel 4: Forekomst af infektioner per behandlingsgruppe (%)
English: Wear protective clothing and use a sunscreen with a high protection factor.
Danish: Du bør bære beskyttende beklædning og anvende solcreme med høj beskyttelsesfaktor.
English: At Year 3, the incidence of NODM was 8% with belatacept and 10% with ciclosporin.
Danish: Ved år 3 var hyppigheden for NODM 8% med belatacept og 10% med ciclosporin.
English: Your doctor may need to investigate your symptoms to rule out PML, PTLD or other infections.
Danish: Lægen vil muligvis undersøge dine symptomer for at udelukke PML, PTLD eller andre infektioner.
English: Belatacept is not expected to interrupt the enterohepatic recirculation of MPA.
Danish: Belatacept forventes ikke at afbryde den enterohepatiske recirkulation af MPA.
English: Cases of PTLD varied by serostatus.
Danish: PTLD-tilfældene varierede efter serostatus.
English: After dilution, and from a microbiological point of view, the product should be used immediately.
Danish: Efter fortynding og fra et mikrobiologisk synspunkt bør lægemidlet anvendes straks.
English: However you should not drive or operate any machines if you are feeling tired or unwell after receiving NULOJIX.
Danish: Du må ikke køre eller arbejde med maskiner, hvis du føler dig træt eller utilpas efter behandling med NULOJIX.
English: The higher calculated GFR observed in belatacept-treated patients relative to ciclosporin-treated patients during the first 3 years was maintained over the long-term extension period.
Danish: Den højere beregnede GFR, der blev observeret hos belataceptbehandlede patienter i forhold til ciclosporinbehandlede patienter i løbet af de første 3 år, blev opretholdt under langtidsopfølgningen.
English: CMV prophylaxis is recommended for at least 3 months after transplantation, particularly for patients at increased risk for CMV infection.
Danish: CMV-profylakse anbefales i mindst 3 måneder efter transplantation, især hos patienter med øget risiko for CMV-infektion.
English: In general, antibody titers were low, not usually persistent, and often became undetectable with continued treatment.
Danish: Som regel var antistoftitrene lave, ikke vedvarende og kunne ofte ikke detekteres ved fortsat behandling.
English: It is not known whether these findings indicate a risk for development of autoimmune diseases in humans exposed in utero to abatacept or belatacept.
Danish: Det vides ikke om disse fund udgør en risiko for udvikling af autoimmune sygdomme hos mennesker, der eksponeres in utero for abatacept eller belatacept.
English: This Patient Alert Card includes information that will be helpful to you and alert other doctors that you have a transplanted kidney and are on a potent medicine to keep your kidney working.
Danish: Dette patient informationskort indeholder oplysninger, som kan være nyttige for dig og advare andre læger om, at du har en transplanteret nyre og behandles med en kraftig medicin for at nyren skal blive ved med at fungere.
English: Following administration, it is recommended that the intravenous line be flushed with infusion fluid to ensure administration of the complete dose.
Danish: Efter administration anbefales det at skylle intravenøsslangen med infusionsvæske for at sikre at den fulde dosis administreres.
English: Syringes are marked in units of 0.5 ml; therefore, the calculated dose should be rounded to the nearest 0.5 ml.
Danish: Sprøjten er opdelt i enheder på 0,5 ml og den beregnede dosis skal derfor afrundes til den nærmeste 0,5 ml.
English: The safety and efficacy of retreatment with belatacept has not been studied.
Danish: Sikkerhed og effekt ved genbehandling med belatacept er ikke blevet undersøgt.
English: Your doctor will advise you about using a reliable contraceptive.
Danish: Lægen vil rådgive dig om sikker prævention.
English: Therapeutic monitoring of belatacept is not required.
Danish: Terapeutisk monitorering af belatacept er ikke nødvendig.
English: Contrada Fontana del Ceraso 03012 Anagni (FR) - Italy
Danish: Contrada Fontana del Ceraso 03012 Anagni (FR) - Italien
English: Pneumocystis pneumonia prophylaxis is recommended for at least 6 months following transplantation.
Danish: Profylakse af pneumocystis pneumoni anbefales i mindst 6 måneder efter transplantation.
English: Nine of 14 cases of PTLD in belatacept-treated patients were located in the CNS; within the observation period, 8 of 14 cases were fatal (6 of the fatal cases involved the CNS).
Danish: Ni ud af 14 tilfælde af PTLD hos belatacept-behandlede patienter var lokaliseret i CNS; i observationsperioden var 8 af 14 tilfælde med dødelig udgang (6 af de fatale tilfælde omfattede CNS).
English: Your doctor will advise you what to do.
Danish: Lægen vil rådgive dig.
English: The viral status was not determined in the belatacept study but, as this virus is prevalent in monkeys, it was likely present in these monkeys as well.
Danish: Den virale status blev ikke undersøgt i belatacept-studiet, men da dette virus er udbredt hos aber, forekom det sandsynligvis også hos disse aber.
English: This will avoid aggregate formation.
Danish: Dette forhindrer aggregation.
English: During the first month post-transplantation, 85% saturation of CD86 was maintained.
Danish: I den første måned efter transplantation blev en mætning af CD86 på 85% opretholdt.
English: In a six-month and one-year toxicity study in cynomolgus monkeys with belatacept and abatacept, respectively, no significant toxicity was observed.
Danish: I et seks måneders og 1-årigt toksicitetsforsøg med cynomolgus-aber med henholdsvis belatacept og abatacept blev der ikke observeret signifikant toksicitet.
English: Liver inflammation (cytolytic hepatitis)
Danish: Leverbetændelse (cytolytisk hepatitis)
English: Dates of NULOJIX Treatment:
Danish: Datoer for NULOJIX-behandling:
English: A total of 45 of 847 patients (5.3%) developed antibodies during treatment with belatacept.
Danish: I alt 45 ud af 847 patienter (5,3%) udviklede antistoffer under behandling med belatacept.
English: The decision to stop using NULOJIX should be discussed with your doctor and another therapy will generally be started.
Danish: Beslutningen om at holde op med NULOJIX skal tages i samråd med lægen og en anden behandling vil normalt blive påbegyndt.
English: Initial phase
Danish: Indledende fase
English: Exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Danish: Udsættelse for sollys og ultraviolet (UV) lys bør begrænses ved at bære beskyttende beklædning og anvende solcreme med høj beskyttelsesfaktor.
English: This will avoid foam formation.
Danish: Dette forhindrer dannelsen af skum.
English: T-cells are cells responsible for maintaining your body's ability to resist disease and infections.
Danish: T-celler sørger for at opretholde kroppens evne til at modstå sygdomme og infektioner.
English: Anti-belatacept antibody development was not associated with altered clearance of belatacept.
Danish: Dannelse af anti-belatacept antistoffer var ikke associeret med ændret clearance af belatacept.
English: Remove the flip off seal from the vial and wipe the top with an alcohol swab.
Danish: Fjern forseglingen fra hætteglasset, og tør toppen af med en alkohol-serviet.
English: However, immunogenicity rate normalised for duration of exposure was consistent at 2.0 to 2.1 per 100 patient years among the three studies.
Danish: Den normaliserede immunogenicitetsfrekvens for eksponeringsvarighed var imidlertid den samme (2,0-2,1 per 100 patientår) i de tre studier.
English: The potential impact of pre-existing antibodies to belatacept should be taken into account when considering retreatment with belatacept following prolonged discontinuation, particularly in patients who have not received continuous immunosuppression.
Danish: Den potentielle indvirkning af allerede eksisterende antistoffer mod belatacept bør tages i betragtning ved overvejelser om genbehandling med belatacept efter længerevarende behandlingsophør, især hos patienter, som ikke har været i kontinuerlig immunsuppressiv behandling.
English: This increased avidity provides a level of immunosuppression that is necessary for preventing immune-mediated allograft failure and dysfunction.
Danish: Denne øgede binding medfører et niveau af immunsuppresion som er nødvendigt for at forebygge immunmedieret allograftafstødning og dysfunktion.
English: The dose of corticosteroids used in all treatment groups was tapered during the first 6 months following transplantation.
Danish: Kortikosteroiddosis i alle behandlingsgrupper blev nedtrappet i løbet af de første 6 måneder efter transplantationen.
English: An additional 51 patients were treated for an average of 7 years in the long-term extension of a Phase 2 study.
Danish: Yderligere 51 patienter blev behandlet i gennemsnitlig 7 år i forlængelsesarmen af fase 2-studiet.
English: Phase 2 liver transplant study
Danish: Fase 2-levertransplantationsstudie
English: Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA28.
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, selektive immunsuppressiva, ATC-kode: L04AA28.
English: Start (Day of Transplant):_______________ Most recent: _________________________ Next treatment date:____________________ Patient's Name:_______________________ Doctor's Name:_______________________ Doctor's Phone:_______________________ If NULOJIX is stopped, keep this card with you for an additional 3 months.
Danish: Næste behandling:_____________________ Patientens navn: _____________________ Lægens navn: _______________________ Lægens telefonnummer: _______________ Dette kort bør du bære i 3 måneder efter den sidste NULOJIX-dosis.
English: New Onset Diabetes Mellitus and Blood Pressure
Danish: Nydebuteret diabetes mellitus og blodtryk
English: Very Common insomnia, anxiety
Danish: Meget almindelig insomni, angst
English: PTLD in belatacept-treated patients most often presented in the central nervous system (CNS).
Danish: PLTD hos belatacept-behandlede patienter viste sig som oftest i centralnervesystemet (CNS).
English: There was one case of PML reported (Study 1) in the ciclosporin group at 82 months post-transplant (more than 56 days after discontinuing therapy).
Danish: Der blev rapporteret et tilfælde af PML (Studie 1) i ciclosporingruppen 82 måneder efter transplantation (mere end 56 dage efter behandlingen var blevet seponeret).
English: Belatacept is produced by recombinant DNA technology in a mammalian cell expression system.
Danish: Belatacept fremstilles ved rekombinant DNA-teknologi i ekspressionssystemet i en mammalcelle.
English: The active substance is belatacept.
Danish: Aktivt stof: belatacept.
English: At a given dose of MMF, MPA exposure is approximately 40% higher with belatacept coadministration than with ciclosporin coadministration.
Danish: Ved en given dosis af MMF er MPA-eksponeringen ca. 40% højere ved samtidig administration med belatacept end ved samtidig administration med ciclosporin.
English: Dose of belatacept for renal transplant recipients
Danish: Belatacept-dosis til nyretransplantationspatienter
English: Activated T cells are the predominant mediators of immunologic response to the transplanted kidney.
Danish: Aktiverede T-celler er de primære mediatorer ved immunologisk respons i den transplanterede nyre.
English: Contrada Fontana del Ceraso I-03012 Anagni-Frosinone Italy
Danish: Contrada Fontana del Ceraso I-03012 Anagni-Frosinone Italien
English: Dangerous decrease of blood pressure which, if untreated, may lead to collapse, coma and death Stroke
Danish: Alvorligt fald i blodtrykket, der, hvis det ikke behandles, kan medføre kollaps, koma og død Slagtilfælde
English: Efficacy was similar between MI and LI while the overall safety profile was better for the LI.
Danish: Den kliniske effekt var ens i MI og LI, mens den overordnede bivirkningsprofil var bedre for LI.
English: Patients do not require pre-medication prior to administration of belatacept.
Danish: Patienter har ikke behov for præmedicinering inden administration af belatacept.
English: Lymphocyte depleting therapies to treat acute rejection should be used cautiously.
Danish: Lymfocyt-depleterende terapi til behandling af akut afstødning bør anvendes med forsigtighed.
English: Important information about some of the ingredients of NULOJIX Tell your doctor if you are on a low-sodium (low-salt) diet before you are treated with NULOJIX.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i NULOJIX Fortæl det til lægen, hvis du er på en saltfattig diæt, inden du behandles med NULOJIX.
English: The majority of cases of tuberculosis occurred in patients who currently live or previously lived in countries with a high prevalence of tuberculosis.
Danish: Størstedelen af tuberkulose-tilfældene forekom hos patienter, der boede eller tidligere havde boet i lande med en høj prævalens af tuberkulose.
English: Belatacept appears not to have any relevant direct effects on cytokine levels in liver transplant recipients or in healthy volunteers.
Danish: Belatacept synes ikke at have nogen relevant direkte effekt på cytokinniveauet hos levertransplanterede patienter eller hos raske forsøgspersoner.
English: If you have not been exposed to the Epstein-Barr virus (EBV) or are uncertain of previous exposure, you must not be treated with NULOJIX.
Danish: hvis du ikke har haft Epstein-Barr virus (EBV), eller ikke er sikker på, om du har haft den, må du ikke behandles med NULOJIX.
English: As compared to the results from the initial 3 years, no new adverse reactions or increasing incidence of adverse reactions (listed above from the initial 3-year period) were detected during the 4-year long-term open label extension.
Danish: I sammenligning med resultaterne fra de første 3 år blev der ikke registreret nye bivirkninger eller en øget forekomst af bivirkninger (anført ovenfor fra den første 3-årige periode) i 4-årige åbne langtidsopfølgningsperiode.
English: Method of administration NULOJIX is for intravenous use only.
Danish: Administration NULOJIX er kun til intravenøs anvendelse.
English: Reversible pharmacological effects consisted of minimal decreases in serum IgG and minimal to severe lymphoid depletion of germinal centers in the spleen and/or lymph nodes.
Danish: Reversibel farmakologisk effekt omfattede minimale, forbigående fald i serum-IgG og minimalt til svær depletion i milten og/eller lymfekirtlernes germinalcenter.
English: If you stop treatment with NULOJIX for a long period of time, without taking any other medicines to prevent rejection, and then restart, it is not known if belatacept will have the same effect as before.
Danish: Hvis du stopper din behandling med NULOJIX i længere tid og ikke anvender anden medicin, der skal forhindre afstødning og igen begynder at anvende belatacept, er det uvist, om belatacept vil have den samme effekt igen.
English: Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse New York 13057 - U.S.A.
Danish: Bristol-Myers Squibb Company 6000 Thompson Road, East Syracuse Ney York 13057 - U.S.A.
English: Belatacept has a minor influence on the ability to drive and use machines.
Danish: Belatacept påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: The trough concentration of belatacept was consistently maintained up to 5 years post-transplant.
Danish: Den laveste koncentration af belatacept blev opretholdt i op til 5 år efter transplantation.
English: In 153 patients assessed for antibodies at least 56 days (approximately 7 half-lives) after discontinuation of belatacept, an additional 10 (6.5%) developed antibodies.
Danish: Ud af 153 patienter, der blev undersøgt for antistoffer i mindst 56 dage (ca. 7 halveringstider) efter seponering af belatacept, udviklede yderligere 10 (6,5%) antistoffer.
English: Immunosuppressant therapy may affect response to vaccination.
Danish: Immunsuppressiv behandling kan påvirke effekten af vaccinen.
English: Depending on the type of kidney transplant that you received, you may be at higher risk of blood clotting in your transplanted kidney.
Danish: Afhængig af hvilken type nyretransplantation du har fået foretaget, kan du have en øget risiko for at få en blodprop i den transplanterede nyre.
English: Studies in rats have shown excretion of belatacept in milk.
Danish: Studier med rotter har vist, at belatacept udskilles i mælken.
English: With NULOJIX treatment, this more often develops in the brain and can lead to death.
Danish: Med NULOJIX-behandling opstår PTLD hyppigere i hjernen og kan være dødelig.
English: By Year 3 recurrent AR was similar across groups (< 3%) and subclinical AR identified on the 1 year protocol biopsy was 5% in both groups.
Danish: Ved år 3 var recidiverende AR ens for begge grupper (< 3%) og subklinisk AR, som blev identificeret ved protokolbiopsi ved år 1, var 5% i begge grupper.
English: Belatacept binds to CD80 and CD86 on antigen presenting cells.
Danish: Belatacept bindes til CD80 og CD86 på antigenpræsenterende celler.
English: You are being treated with a potent medicine that suppresses the immune system.
Danish: Du er i behandling med en kraftigt virkende medicin, der hæmmer immunsystemet.
English: Belatacept has less activity in rodents than abatacept, a fusion protein that differs from belatacept by two amino acids in the CD80/86 binding domains.
Danish: Belatacept udøver mindre aktivitet i gnavere end abatacept, som er et fusionsprotein, der adskiller sig fra belatacept ved to aminosyrer i de CD80/86-bindende domæner.
English: Women should not breast-feed while on treatment with a belatacept-based regimen.
Danish: Kvinder bør ikke amme under behandling med et belatacept-baseret behandlingsregime.
English: Patient and Graft Survival (%) Year 1 [95% CI]
Danish: Patient- og transplantatoverlevelse (%) År 1 [95% CI]
English: Population pharmacokinetic analyses in renal transplant patients revealed that there was a trend toward higher clearance of belatacept with increasing body weight.
Danish: Farmakokinetiske populationsanalyser med nyretransplantationspatienter viste en tendens til højere clearance af belatacept med stigende kropsvægt.
English: Patients are not required to be pre-treated to prevent allergic reactions (see section 4.8).
Danish: Det er ikke nødvendigt, at patienter præmedicineres for at forhindre allergiske reaktioner (se pkt.
English: For a list of symptoms please see section 4, “Possible side effects”.
Danish: Se listen over symptomer i afsnit 4 ”Bivirkninger”.
English: For patients who may be switched from belatacept to another immunosuppressant, physicians should be aware of the 8-10 day half-life of belatacept to avoid potential under- or over-immunosuppression following discontinuation of belatacept.
Danish: Hos patienter, som muligvis skifter fra belatacept til anden immunsuppressivum, bør lægen være opmærksom på belatacepts halveringstid på 8-10 dage for at undgå potentiel under- eller overimmunsuppression efter seponering af belatacept.
English: No clinically relevant effects of age, gender, race, renal function (calculated GFR), diabetes, or concomitant dialysis on clearance of belatacept was identified.
Danish: Der er ikke identificeret nogen klinisk relevant effekt af alder, køn, race, nyrefunktion (målt ud fra beregnet GFR), diabetes eller samtidig dialyse på clearance af belatacept.
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 til stede.
English: Acute infusion-related reactions (reactions occurring within one hour of infusion) occurred in 5.5% of patients in the belatacept MI group and 4.4% of patients in the belatacept LI group up to Year 3.
Danish: Akutte infusionsrelaterede reaktioner (bivirkninger der opstod inden for 1 time efter påbegyndelse af infusionen) forekom hos 5,5% af patienterne i belatacept MI-gruppen og 4,4% af patienterne i belatacept LI-gruppen op til år 3.
English: Based on population pharmacokinetic analysis of 944 renal transplant patients up to 1 year posttransplant, the pharmacokinetics of belatacept were similar at different time periods post-transplant.
Danish: Baseret på en farmakokinetisk populationsanalyse af 944 nyretransplantationspatienter op til 1 år efter transplantation var belatacepts farmakokinetik ens i de forskellige perioder efter transplantation.
English: The recommended dose is based on your body weight (in kg) and will be calculated by a healthcare professional.
Danish: Den anbefalede dosis afhænger af din vægt (i kg) og bliver beregnet af en læge eller sygeplejerske.
English: Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown.
Danish: Transplantationspatienter som er Epstein-Barr-virus (EBV) seronegative eller hvis serostatus er ukendt.
English: In Study 2, approximately 40% reduction in this risk was observed among patients in the belatacept groups as compared with those assigned to ciclosporin.
Danish: I Studie 2, blev der observeret en reduktion på ca. 40 % j denne risiko blandt patienter i belataceptgrupperne sammenlignet med patienter i ciclosporingruppen.
English: Of the 6 PTLD cases in the LI regimen, 3 involved the CNS and were fatal.
Danish: Af de 6 tilfælde af PTLD i LI-gruppen omfattede 3 CNS og havde dødelig udgang.
English: Limit your exposure to sunlight and ultraviolet (UV) light whilst using NULOJIX.
Danish: Du bør begrænse din udsættelse for sollys og ultraviolet (UV) lys, så længe du er i behandling med NULOJIX.
English: At the recommended dosing regimen of belatacept there were 404 EBV positive recipients and 4 cases of PTLD occurred (1.0%); 2 of these presented in the CNS.
Danish: Ved det anbefalede dosisregime for belatacept var der 404 EBV-positive recipienter, og der forekom 4 tilfælde af PTLD (1,0%); 2 af disse opstod i CNS.
English: Although there were few patients that developed antibodies and there was no apparent correlation of antibody development to clinical response or adverse events, the data are too limited to make a definitive assessment (see section 4.8).
Danish: Selvom få patienter udviklede antistoffer og der ikke var nogen umiddelbar korrelation mellem antistofudvikling og klinisk respons eller bivirkninger, er data for begrænsede til at kunne lave en definitiv vurdering (se pkt.
English: If you become pregnant while using NULOJIX, tell your doctor.
Danish: Hvis du bliver gravid, mens du behandles med NULOJIX, skal du informere lægen.
English: Use with other immunosuppressive medicines
Danish: Samtidig anvendelse af andre immunsuppressiva
English: There is a theoretical concern that treatment with belatacept might increase the risk of autoimmune processes (see section 4.8).
Danish: Der er teoretiske overvejelser om, at behandling med belatacept kan øge risikoen for autoimmune processer (se pkt.