FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose selection and reconstitution of the vials Calculate the dose and number of NULOJIX vials required.
Danish: Fastsættelse af dosis og rekonstituering af hætteglas Beregn dosis og det antal NULOJIX-hætteglas, der er behov for.
English: Among Study 2 patients who were EBV seronegative at the time of transplant (for whom use of belatacept is not recommended), there were three cases of PTLD in the belatacept LI group, and none in the belatacept MI and ciclosporin groups.
Danish: Blandt de patienter i Studie 2, der var EBV-seronegative på transplantationstidspunktet (belatacept anbefales ikke til disse patienter), var der tre tilfælde af PTLD i belatacept LI-gruppen og ingen i belatacept MI- og ciclosporingrupperne.
English: One patient on belatacept MI regimen developed Guillian-Barré syndrome which led to treatment discontinuation and subsequently resolved.
Danish: En patient i belatacept MI-regimen udviklede Guillain-Barrés syndrom, som medførte seponering af behandlingen og derefter forsvandt syndromet.
English: Acute rejection (AR) occurred more frequently with belatacept versus ciclosporin in Study 1 and with similar frequency with belatacept versus ciclosporin in Study 2.
Danish: Akut afstødning (AR) forekom hyppigere med belatacept end med ciclosporin i studie 1 og med nogenlunde samme hyppighed med belatacept som med ciclosporin i studie 2.
English: To minimise foam formation, gently swirl and invert the vial for at least 30 seconds or until the powder is completely dissolved.
Danish: For at minimere skumdannelse vendes hætteglasset med forsigtige, roterende bevægelser i mindst 30 sekunder eller indtil pulveret er fuldstændig opløst.
English: In a Phase 2 study, there were 2 cases of graft thrombosis, 1 each in MI and LI (incidence of 1.4% for both) versus 0 in the ciclosporin group.
Danish: I et fase 2-studie var der 2 tilfælde af grafttrombose, en hver i MI og LI (hyppighed på 1,4% for begge) versus 0 i ciclosporin-gruppen.
English: Blood clotting in your transplanted kidney
Danish: Blodpropper i din transplanterede nyre
English: Malignancies excluding nonmelanoma skin cancer and PTLD
Danish: Maligniteter undtagen nonmelanom hudcancer og PTLD
English: Packs of either 1 glass vial and 1 syringe or 2 glass vials and 2 syringes.
Danish: Pakker med enten 1 hætteglas af glas og 1 sprøjte eller 2 hætteglas af glas og 2 sprøjter.
English: You must not get pregnant while using NULOJIX.
Danish: Du bør ikke blive gravid, mens du får behandling med NULOJIX.
English: In clinical studies, belatacept-treated transplant recipients with EBV seronegative status were at an increased risk for PTLD compared with those who were EBV positive (7.7%; 7/91 versus 0.7%; 6/810, respectively).
Danish: I kliniske studier havde belatacept-behandlede transplantatrecipienter med EBVseronegativ status en øget risiko for PTLD sammenlignet med de transplantationspatienter, der var EBV-positive (henholdsvis 7,7%; 7/91 versus 0,7%; 6/810).
English: In this study, 666 patients were enrolled, randomised, and transplanted; 219 to belatacept MI, 226 to belatacept LI, and 221 to ciclosporin.
Danish: I dette studie deltog 666 randomiserede patienter, som gennemgik en transplantation; 219 med belatacept MI, 226 med belatacept LI og 221 med ciclosporin.
English: As an increased risk of PML and of other infections has been associated with high levels of overall immunosuppression, the recommended doses of belatacept and concomitant immunosuppressives, including MMF or MPA, should not be exceeded (see section 4.5).
Danish: Eftersom en øget risiko for PML og andre infektioner er blevet associeret med en høj grad af overordnet immunsuppression, bør de anbefalede doser af belatacept og samtidig immunsuppressiva, inklusiv MMF eller mycophenolsyre, ikke overskrides (se pkt.
English: Use of immunosuppressants, including belatacept, can increase susceptibility to infection, including fatal infections, opportunistic infections, tuberculosis, and herpes (see progressive multifocal leukoencephalopathy (PML) warning below and also section 4.8).
Danish: Anvendelse af immunsuppressiva, herunder belatacept, kan øge modtageligheden over for infektion, herunder fatale infektioner, opportunistiske infektioner, tuberkulose og herpes (se nedenstående advarsel om progressiv multifokal leukoencefalopati (PML) samt pkt.
English: In postmarketing experience, use of belatacept in conjunction with basiliximab induction, mycophenolate mofetil and corticosteroid taper to 5 mg/day by Week 6 post-transplant was associated with an increased rate of acute rejection, particularly Grade III rejection.
Danish: Efter markedsføring er betalacept, i kombination med basiliximab-induktion, mycophenolatmofetil og nedtrapning af kortikosteroid til 5 mg/dag ved uge 6 efter transplantationen, blevet associeret med en øget hyppighed af akut afstødning, især grad III-afstødning.
English: It is unknown whether belatacept is excreted in human milk (see section 5.3).
Danish: Det vides ikke om belatacept udskilles i human modermælk (se pkt.
English: The belatacept dosing used in this liver study was higher in all 3 belatacept arms than the belatacept dosing used in the Phase 2 and 3 renal transplant studies.
Danish: Belatacept-dosis i dette leverstudie var i alle 3 belatacept-grupper højere end belatacept-dosis i fase 2 og 3 nyretransplantationsstudierne.
English: In clinical trials, an increased incidence of graft thrombosis was observed in the post-transplant period in recipients of extended criteria donor allografts.
Danish: I kliniske studier blev der observeret en øget forekomst af grafttrombose i posttransplantationsperioden hos modtagere af extended criteria allotransplantater fra donor (se pkt.
English: Treatment should be prescribed and supervised by specialist physicians experienced in the management of immunosuppressive therapy and of renal transplant patients.
Danish: Behandling skal initieres og superviseres af speciallæger med erfaring med immunsuppressiv behandling og behandling af nyretransplantationspatienter.
English: *Median exposure for pooled studies is 1,092 days for each treatment group.
Danish: *Gennemsnitlig eksponering for puljede studier er 1092 dage for hver behandlingsgruppe.
English: Chronic Allograft Nephropathy/Interstitial Fibrosis and Tubular Atrophy (IFTA) The prevalence of CAN/IFTA at Year 1 in Studies 1 and 2, was numerically lower with belatacept than ciclosporin (~ 9.4% and 5%, respectively).
Danish: Kronisk allograftnefropati/Interstitiel fibrose og tubulær atrofi (IFTA) Forekomsten af CAN/IFTA i år 1 ved studie 1 og 2 var numerisk lavere med belatacept end med ciclosporin (henholdsvis ~ 9,4% og 5%).
English: Thus, 10 ml of a 25 mg/ml belatacept solution can be withdrawn from each vial.
Danish: Derfor kan der udtages 10 ml af 25 mg/kg belatacept-opløsning fra hvert hætteglas.
English: NULOJIX should not be used with siliconised syringes in order to avoid aggregate formation (see section 6.6).
Danish: NULOJIX må ikke anvendes med silikonebehandlede sprøjter for at undgå aggregation (se pkt.
English: If you miss receiving NULOJIX when you are supposed to, ask your doctor when to schedule your next dose.
Danish: Hvis du ikke har fået NULOJIX, som du skulle have haft, skal du spørge lægen, hvornår du næste gang skal have en dosis.
English: Malignancies and post-transplant lymphoproliferative disease Year 1 and 3 frequencies of malignancies are shown in Table 3, except for cases of PTLD which are presented at 1 year and > 3 years (median days of follow-up were 1,199 days for belatacept MI, 1,206 days for belatacept LI, and 1,139 days for ciclosporin).
Danish: Maligniteter og Post-transplantation lymfoproliferativ sygdom (PTLD) Hyppigheden af maligniteter ved år 1 og 3 er vist i tabel 3 med undtagelse af tilfælde af PTLD, som vises ved år 1 og > 3 år (gennemsnitligt antal dage for follow-up var 1199 dage for belatacept MI, 1206 dage for belatacept LI og 1139 dage for ciclosporin).
English: Regular administration of NULOJIX is essential for your transplanted kidney to function.
Danish: Regelmæssig behandling med NULOJIX er afgørende for at den transplanterede nyre fungerer.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Pulver til koncentrat
English: Within each frequency category adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: The reconstituted solution should be clear to slightly opalescent and colourless to pale yellow.
Danish: Efter rekonstituering skal opløsningen være klar til let opaliserende og farveløs til svagt gul.
English: It is recommended to add an interleukin (IL)-2 receptor antagonist for induction therapy to this belatacept-based regimen.
Danish: Til induktionsbehandling anbefales tillæg af en interleukin (IL)-2 receptorantagonist til det belatacept-baserede regime.
English: When the clinical suspicion for PML is high, brain biopsy should be considered in subjects if the diagnosis of PML cannot be established via CSF PCR and neuroimaging.
Danish: Ved kraftig klinisk mistanke om PML bør hjernebiopsi overvejes hos personer, hvor PMLdiagnosen ikke kan fastslås ved CSF PCR og hjernescanning.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/694/001-002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/694/001-002
English: In this study, 543 patients were enrolled, randomised, and transplanted; 184 to belatacept MI, 175 to belatacept LI, and 184 to ciclosporin.
Danish: I dette studie deltog 543 randomiserede patienter, som gennemgik en transplantation; 184 med belatacept MI, 175 med belatacept LI og 184 med ciclosporin.
English: There is no data available in patients with hepatic impairment.
Danish: Der foreligger ingen data om patienter med leverinsufficiens.
English: In rats, belatacept had no undesirable effects on male or female fertility.
Danish: Hos rotter havde belatacept ingen uønsket effekt på mandlig eller kvindelig fertilitet.
English: These belatacept dosing regimens differed from those studied in renal transplant recipients (see section 5.1).
Danish: Disse belatacept-behandlingsregimener var forskellige fra dem, der blev undersøgt hos nyretransplanterede patienter (se pkt.
English: Each vial is co-packaged with a disposable polypropylene syringe.
Danish: Hvert hætteglas er pakket sammen med en engangssprøjte af polypropylen.
English: In a mouse carcinogenicity study, increases in the incidence of malignant lymphomas and mammary tumours (in females) occurred.
Danish: Der er i et carcinogenicitetsforsøg med mus set en øget incidens i forekomsten af maligne lymfomer og mammatumorer (hos hunmus).
English: When reconstitution and dilution are performed under aseptic conditions, the NULOJIX infusion should be started immediately or must be completed within 24 hours of reconstitution of the powder.
Danish: Hvis rekonstituering og fortynding er udført under aseptiske forhold, bør infusionen af NULOJIX påbegyndes straks eller inden for 24 timer efter rekonstituering.
English: See leaflet for shelf-life after reconstitution and dilution.
Danish: Se indlægssedlen for holdbarhed efter rekonstituering og fortynding.
English: No physical or biochemical compatibility studies have been conducted to evaluate the coadministration of NULOJIX with other agents.
Danish: Der er ikke udført fysiske eller biokemiske undersøgelser vedrørende eventuelle uforligeligheder, for at vurdere den samtidige administration af NULOJIX med andre lægemidler.
English: Patient and graft survival were similar between belatacept and ciclosporin.
Danish: Patient- og graftoverlevelse var ens for belatacept og ciclosporin.
English: Infections involving the CNS were more frequent in the belatacept MI group (8 cases, including the PML case discussed above; 1.7%) than the belatacept LI (2 cases, 0.4%) and ciclosporin (one case; 0.2%) groups.
Danish: Infektioner, der involverede CNS, var hyppigere i belatacept MI-gruppen (8 tilfælde herunder ovennævnte tilfælde af PML; 1,7%) end i belatacept LI-gruppen (2 tilfælde; 0,4%) og ciclosporingruppen (1 tilfælde; 0,2%).
English: In a clinical study, approximately 90% saturation of CD86 receptors on the surface of antigenpresenting cells in the peripheral blood was observed following the initial administration of belatacept.
Danish: I et klinisk studie efter initial administration af belatacept blev der på celleoverfladen af de antigenpræsenterende celler i perifert blod observeret ca. 90% mætning af CD86-receptorerne.
English: A single, randomised, multi-center, controlled Phase 2 trial of belatacept in de novo orthotopic liver transplant recipients was conducted.
Danish: Der er blevet udført et enkelt, randomiseret, kontrolleret fase 2-multicenterforsøg med belatacept hos de novo ortotopisk levertransplanterede patienter.
English: Physicians should consider PTLD in the differential diagnosis in patients with new or worsening neurologic, cognitive or behavioural signs or symptoms.
Danish: Læger bør overveje PTLD som differentialdiagnose hos patienter med nye eller forværrede neurologiske, kognitive eller adfærdsmæssige objektive fund eller symptomer.
English: The majority of cases of tuberculosis occurred in patients who currently live or previously lived in countries with a high prevalence of tuberculosis (see section 4.4).
Danish: Størstedelen af tuberkulosetilfældene forekom hos patienter, der boede eller tidligere havde boet i lande med en høj prævalens af tuberkulose (se pkt.
English: The solution for infusion is to be used in conjunction with a sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 µm to 1.2 µm).
Danish: Infusionsvæsken skal anvendes sammen med et sterilt, ikke-pyrogent filter med lav proteinbindingsgrad (porestørrelse 0,2-1,2 μm).
English: NULOJIX should not be infused concomitantly in the same intravenous line with other agents.
Danish: NULOJIX må ikke indgives i samme intravenøse slange samtidig med andre lægemidler.
English: The occurrence of autoimmune events across the core clinical studies was infrequent, occurring at rates of 1.7%, 1.7%, and 1.9% by Year 3 for the MI, LI, and ciclosporin groups respectively.
Danish: Forekomsten af autoimmune hændelser i alle kliniske hovedstudier var sjælden og forekom hos henholdsvis 1,7%, 1,7% og 1,9% ved år 3 for henholdsvis MI-, LI- og ciclosporin-gruppen.
English: A dedicated Alert Card has been developed to prompt the patient to reference the package leaflet and HCPs to reference the SmPC for more details on the benefits and risks associated with NULOJIX.
Danish: Der er udarbejdet et særligt informationskort, der henviser patienten til indlægssedlen og sundhedspersonalet til produktresumeet for yderligere oplysninger om fordele og risici associeret med NULOJIX.
English: In the individual studies, the percentage of patients with antibodies ranged from 4.5% and 5.2% in the Phase 3 studies to 11.8% in the long-term extension of the Phase 2 study.
Danish: I de individuelle studier var procentandelen af patienter, som havde udviklet antistoffer i fase 3-studierne, mellem 4,5% og 5,2% til 11,8% i forlængelsesarmen af fase 2-studiet.
English: NULOJIX powder for concentrate for solution for infusion (powder for concentrate) is a white to offwhite powder that can appear solid or broken into pieces.
Danish: NUJOLIX pulver til koncentrat til infusionsvæske, opløsning (pulver til koncentrat) er et hvidt til råhvidt pulver, der kan være i fast form eller i mindre stykker.
English: Transplant recipients who are EBV seronegative or serostatus unknown should not receive belatacept (see section 4.3).
Danish: Transplantationspatienter, som er EBV-seronegative eller hvis serostatus er ukendt, bør ikke få belatacept (se pkt.
English: In addition to EBV seronegative status, other known risk factors for PTLD include cytomegalovirus (CMV) infection and T-cell-depleting therapy, which was more commonly used to treat acute rejection in belatacept-treated patients in Phase 3 clinical studies (see section 5.1).
Danish: Udover EBV-seronegativstatus er nogle af de andre kendte risikofaktorer for PTLD bl.a. cytomegalovirus (CMV) infektion og T-celle-depleterende behandling, som almindeligvis blev anvendt til behandling af akut afstødning hos belatacept-behandlede patienter i kliniske fase 3-studier (se pkt.
English: Mean Calculated GFRc ml/min/1.73 m2 Month 1 Year 1 Year 2 Year 3
Danish: Gennemsnitlig beregnet GFRc ml/min/1,73 m Måned 1 År 1 År 2 År 3
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential should use effective contraception during treatment with belatacept and up to 8 weeks after the last dose of treatment since the potential risk to embryonic/foetal development is unknown.
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder Kvinder i den fertile alder bør anvende effektiv antikonception under behandling med belatacept og op til 8 uger efter sidste behandlingsdosis, da den potentielle risiko for den embryonale/føtale udvikling er ukendt.
English: Keep this Alert Card with you at all times.
Danish: Hav altid dette patient informationskort på dig.
English: Use in liver transplants The use of NULOJIX is not recommended if you have had a liver transplant.
Danish: Anvendelse ved levertransplantationer Behandling med NULOJIX frarådes, hvis du har fået en levertransplantation.
English: *Median follow-up excluding PTLD for pooled studies is 1,092 days for each treatment group.
Danish: *Gennemsnitlig follow-up med udelukkelse af PTLD, for puljede studier er 1092 dage for hver behandlingsgruppe.
English: Uncommon hypogammaglobulinaemia, seasonal allergy Endocrine disorders
Danish: Ikke almindelig hypogammaglobulinæmi, sæsonbestemt allergi Det endokrine system
English: This medicinal product contains 0.65 mmol or 15 mg sodium per vial.
Danish: Dette lægemiddel indeholder 0,65 mmol eller 15 mg natrium pr. hætteglas.
English: Special caution should be exercised in patients with a history of allergic reactions to belatacept or to any of the excipients.
Danish: Der bør udvises særlig forsigtighed hos patienter med allergiske reaktioner over for belatacept eller over for et eller flere af hjælpestofferne i anamnesen.
English: Changes in blood levels of different salts or electrolytes Increased amounts of cholesterol and triglyceride (blood fats) High levels of sugar in your blood
Danish: Ændret koncentration af forskellige salte eller elektrolytter i blodet Øget mængde kolesterol og triglycerid (fedtstoffer i blodet) Højt blodsukkerniveau
English: Post-transplant lymphoproliferative disorder (PTLD) In the Phase 2 and 3 studies (3 studies), the incidence of PTLD was higher in belatacept-treated patients than in ciclosporin-treated patients (see section 4.8).
Danish: Post-transplantation lymfoproliferativ sygdom (PTLD) I fase 2- og 3-studierne (3 studier) var forekomsten af PTLD højere hos belatacept-behandlede patienter end hos ciclosporin-behandlede patienter (se pkt.
English: Remove the syringe and needle after 10.5 ml of reconstitution fluid has been added to the vial.
Danish: Fjern sprøjten og nålen, når de 10,5 ml rekonstitutionsvæske er injiceret i hætteglasset.
English: In both studies, mean GFR following AR was similar in belatacept and ciclosporin treated patients.
Danish: I begge studier var gennemsnitlig GFR efter AR ens hos belatacept- og ciclosporin-behandlede patienter.
English: The entire, fully diluted infusion should be administered over a period of 30 minutes and must be administered with an infusion set and a sterile, non-pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm).
Danish: Al den fortyndede opløsning indgives over en periode på 30 minutter og skal administreres med et infusionssæt og et sterilt, ikke-pyrogent filter med lav proteinbindingsgrad (porestørrelse 0,2 - 1,2 μm).
English: What NULOJIX contains
Danish: NULOJIX indeholder:
English: Every 4 weeks (± 3 days), starting at the end of week 16 after transplantation
Danish: Hver 4. uge (± 3 dage), med start i slutningen af uge 16 efter transplantation
English: Do not use NULOJIX if you are pregnant unless your doctor specifically recommends it.
Danish: Du må ikke bruge NULOJIX, hvis du er gravid, medmindre lægen specifikt anbefaler det. NULOJIX's virkning hos gravide kendes ikke.
English: In both studies, in patients with AR by Year 2, donor-specific antibodies, one of the criteria for diagnosis of antibody-mediated rejection, were present in 6% (2/32, Study 2)-8% (3/39, Study 1) and 20% (4/20, Study 1)-26% (7/27, Study 2) in the belatacept and ciclosporin groups by year 3, respectively.
Danish: I begge studier, hos patienter med AR ved år 2, var donor-specifikke antistoffer, som var et af diagnosekriterierne for antistof-medieret afstødning, til stede hos henholdsvis 6% (2/32, Studie 2)-8% (3/39, Studie 1) og 20% (4/20, Studie 1)26% (7/27, Studie 2) i belatacept- og ciclosporin-grupperne ved år 3.
English: For Studies 1 and 2 at Years 1 and 3, belatacept was associated with 6 to 9 mmHg lower mean systolic blood pressure, approximately 2 to 4 mmHg lower mean diastolic blood pressure, and less use of antihypertensive medicinal products than ciclosporin.
Danish: I studie 1 og 2 ved år 1 og 3 var belatacept associeret med 6 til 9 mmHg laverere gennemsnitlig systolisk blodtryk, ca. 2 til 4 mmHg lavere gennemsnitlig diastolisk blodtryk og lavere forbrug af anithypertensiva end ciclosporin.
English: In rats, belatacept had no undesirable effects on male or female fertility (see section 5.3).
Danish: Hos rotter havde belatacept ingen uønsket virkning på mandlig eller kvindelig fertilitet (se pkt.
English: In clinical studies with belatacept, 2 cases of PML were reported in patients receiving belatacept at doses higher than the recommended regimen.
Danish: I kliniske studier med belatacept blev der rapporteret om 2 tilfælde af PML hos patienter, der fik højere doser af belatacept end anbefalet.
English: If you are of child bearing potential, you should use effective contraception during treatment with NULOJIX and up to 8 weeks after the last dose of treatment since the potential risk to embryonic/foetal development is unknown.
Danish: Hvis du er i den fødedygtige alder, bør du anvende sikker prævention under behandlingen med NULOJIX og op til 8 uger efter den sidste dosis i behandlingen, da den mulige risiko for fosterets eller det ufødte barns udvikling er ukendt.
English: How to use NULOJIX 4.
Danish: Sådan skal du bruge NULOJIX 4.
English: In the liver transplant study, the patient received MMF and corticosteroids as concomitant treatment.
Danish: I levertransplantationsstudiet fik patienten samtidig behandling med MMF og kortikosteroider.
English: NULOJIX is used in adults to prevent the immune system from attacking your transplanted kidney and causing transplant rejection.
Danish: Det anvendes hos voksne til at forhindre, at immunsystemet angriber den transplanterede nyre og frastøder den transplanterede nyre.
English: Belatacept is a fusion protein that is not expected to be metabolised by the cytochrome P450 enzymes (CYPs) and UDP-glucuronosyltransferases (UGTs).
Danish: Belatacept er et fusionsprotein, der ikke forventes at blive metaboliseret via CYP-enzymer eller UDPglukuronosyltransferaser (UGT'er).
English: Belatacept, a modified form of CTLA4-Ig, binds CD80 and CD86 more avidly than the parent CTLA4-Ig molecule from which it is derived.
Danish: Belatacept, som er en modificeret form af CTLA4-Ig, bindes med større aviditet til CD80 og CD86 end det oprindelige modermolekyle CTLA4-Ig.
English: Any malignant neoplasm Non-melanoma skin cancer Malignant neoplasms excluding nonmelanoma skin cancers
Danish: Samtlige maligne neoplasier Non-melanom hudcancer Maligne neoplasier undtagen nonmelanom hudcancer PTLD
English: The median age was 58 years; 67% of the study population was male; 75% of patients were white, 13% were black/African-American, 12% were categorised as of other races; 3% had PRA  10%; and 53% had 4 to 6 HLA mismatches.
Danish: Gennemsnitsalderen var 58 år; 67% af studiepopulationen var mænd; 75% af patienterne var hvide, 13% var sorte/afroamerikanere, 12% blev kategoriseret som andre racer; 3% havde PRA ≥10%, og 53% havde 4-6 mismatch på HLA.