FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been reports of a rare type of brain infection called progressive multifocal leukoencephalopathy (PML) that have occurred in patients who have been given NULOJIX.
Danish: En sjælden type hjerneinfektion kaldet progressiv multifokal leukoencefalopati (PML) er blevet rapporteret hos patienter, der har fået NULOJIX.
English: Ask your doctor or pharmacist for advice before taking any other medicine while using NULOJIX.
Danish: Spørg lægen eller på apoteket, før du tager nogen som helst anden form for medicin, mens du behandles med NULOJIX.
English: The adverse reaction profile associated with immunosuppressive agents is often difficult to establish due to the underlying disease and the concurrent use of multiple medicinal products.
Danish: Bivirkningsprofilen for immunsuppressiva er ofte vanskelig at fastlægge på grund af den underliggende sygdom og den samtidige brug af forskellige andre lægemidler.
English: Belatacept is a fusion protein produced in Chinese hamster ovary cells by recombinant DNA technology.
Danish: Belatacept er et fusionsprotein fremstillet i ovarieceller fra kinesiske hamstre ved hjælp af rekombinant DNA-teknologi.
English: If PML is diagnosed, reduction or withdrawal of immunosuppression is recommended taking into account the risk to the graft.
Danish: Ved konstateret PML anbefales reduktion eller seponering af immunsuppressiva under hensyntagen til risikoen for transplantatet.
English: Within the belatacept clinical program, there were 2 patients diagnosed with PML.
Danish: I det kliniske program for belatacept blev 2 patienter diagnosticeret med PML.
English: Up to Year 3*
Danish: Op til år 3*
English: This card should be provided in each pack, the text of which is included in Annex III.
Danish: Kortet, hvis tekst er inkluderet i Anneks III, skal være indeholdt i alle pakninger.
English: Elderly patients demonstrated consistency with the overall study population for safety and efficacy as assessed by patient and graft survival, renal function, and acute rejection.
Danish: Ældre patienter viste overensstemmelse med den samlede studiepopulation med hensyn til sikkerhed og effekt vurderet ud fra patient- og transplantatoverlevelse, nyrefunktion og akut afstødning.
English: Pain when passing urine, blood in the urine
Danish: Smerter ved vandladning, blod i urinen
English: EBV serology should be ascertained before starting administration of belatacept.
Danish: EBV-serologien bør være klarlagt inden administration af belatacept.
English: Belatacept has a minor influence on the ability to drive and use machines since it may cause fatigue, malaise and/or nausea.
Danish: Belatacept påvirker i mindre grad evnen til at føre motorkøretøj eller betjene maskiner, eftersom det kan medføre træthed, utilpashed og/eller kvalme.
English: Tell your doctor immediately if you or your family notice any symptoms listed below:
Danish: Kontakt straks lægen, hvis du eller din familie bemærker et af følgende:
English: Inflammation of the stomach and intestines, usually caused by a virus Upset stomach
Danish: Inflammation i maven og tarmene, som oftest forårsaget af en virus Maveproblemer
English: Information for medical and healthcare professionals on dose calculation, preparation and administration of NULOJIX is provided at the end of the leaflet.
Danish: Information til læger og sundhedspersonale om beregning af dosis, klargøring og indgivelse af NULOJIX er anført sidst i indlægssedlen.
English: **Median follow-up for PTLD for pooled studies is 1,199 days for MI, 1,206 days for LI, and 1,139 days for ciclosporin.
Danish: **Gennemsnitlig follow-up for PTLD for puljede studier er 1199 dage for MI, 1206 dage for LI og 1139 dage for ciclosporin.
English: Unopened vials 3 years
Danish: Uåbnede hætteglas 3 år.
English: The pharmacokinetics of belatacept was linear and the exposure to belatacept increased proportionally in healthy subjects after a single intravenous infusion dose of 1 to 20 mg/kg.
Danish: Belatacepts farmakokinetik var lineær og eksponeringen for belatacept steg proportionelt hos raske forsøgspersoner efter en enkelt intravenøs infusionsdosis på 1 til 20 mg/kg.
English: Although some foam may remain on the surface of the reconstituted solution, a sufficient excess of belatacept is included in each vial to account for withdrawal losses.
Danish: Selvom der stadig kan være skum tilbage på overfladen af den rekonstituerede opløsning indeholder hvert hætteglas tilstrækkelig med belatacept til at kompensere for tab under udtagning.
English: Treatment with NULOJIX will be prescribed and supervised by a specialist in kidney transplantation.
Danish: Behandling med NULOJIX vil blive ordineret og overvåget af en speciallæge i nyretransplantationer.
English: There are no data on use of belatacept and effect on fertility in humans.
Danish: Der foreligger ingen data om belatacepts effekt på human fertilitet.
English: Your body may reject the transplanted kidney if you stop using NULOJIX.
Danish: Din krop kan afstøde den transplanterede nyre, hvis du holder op med NULOJIX.
English: There was an increase in viral and fungal infections in the belatacept groups versus the tacrolimus groups, however overall frequency of serious infections was not different among all treatment groups (see section 4.4).
Danish: Der var en øget forekomst af virus- og svampeinfektioner i belatacept grupperne versus tacrolimus-grupperne, men den samlede forekomst af alvorlige infektioner varimidlertid ikke forskellig blandt alle behandlingsgrupper (se pkt.
English: Fungal infections Tuberculosis
Danish: Svampeinfektioner Tuberkulose
English: An excess in mortality and graft loss was observed in the belatatacept LI + MMF group and an excess in mortality was observed in the belatacept MI + MMF group.
Danish: Der er observeret overdødelighed og transplantattab i belatatacept LI + MMF-gruppen og der er observeret overdødelighed i belatacept MI + MMF-gruppen.
English: Adequate treatment of latent tuberculosis infection should be instituted prior to belatacept use.
Danish: Adækvat behandling af latent tuberkuloseinfektion bør iværksættes inden behandling med belatacept.
English: The more intensive (MI) regimen, which included higher and more frequent dosing during the first 6 months post transplant, resulted in 2-fold higher exposure to belatacept than the less intensive (LI) regimen during Months 2 through 7 post transplant.
Danish: Det mere intensive (MI) regime, som omfattede højere og hyppigere doser end LI-regimet i de første 6 måneder efter transplantation, medførte 2 gange højere eksponering af belatacept end det mindre intensive (LI) regime i måned 2-7 efter transplantation.
English: Minimal systemic accumulation of belatacept occurred upon multiple infusions of 5 or 10 mg/kg doses in renal transplant patients every 4 weeks.
Danish: Minimal systemisk akkumulation af belatacept opstod efter flere infusioner på 5 eller 10 mg/kg doser hos nyretransplantationspatienter hver 4. uge.
English: Table 3: Malignancies occurring by treatment group (%) Up to Year 1
Danish: Tabel 3: Forekomst af maligniteter i de enkelte behandlingsgrupper (%) Op til år 1
English: As a result, belatacept blocks CD28 mediated co-stimulation of T cells inhibiting their activation.
Danish: Som følge heraf blokkere belatacept den CD28-medierede costimulation af T-celler og hæmmer derved deres aktivitet.
English: Take all medicines as instructed by your doctor.
Danish: Tag altid al medicin nøjagtigt efter lægens anvisning.
English: The increased incidence of lymphomas and mammary tumours observed in mice treated with abatacept may have been associated with decreased control of murine leukaemia virus and mouse mammary tumour virus, respectively, in the presence of long-term immunomodulation.
Danish: Den øgede forekomst af lymfomer og mammatumorer hos mus behandlet med abatacept kan være forbundet med nedsat kontrol af henholdsvis det murine leukæmivirus og musemammatumorvirus ved længerevarende immunmodificerende behandling.
English: They may cause rejection of your transplanted kidney.
Danish: De kan medføre afstødning af din transplanterede nyre.
English: Because of the risk of a high total burden of immunosuppression, belatacept should only be used in these patients after consideration of alternative therapy (see section 4.4).
Danish: På grund af risikoen ved en høj samlet immunsuppressiv belastning bør belatacept kun anvendes til disse patienter, efter alternativ behandling er blevet overvejet (se pkt.
English: The overall occurrence of tuberculosis infections and non-serious herpes infections were higher for belatacept regimens than for the ciclosporin regimen.
Danish: Den samlede forekomst af tuberkuloseinfektioner og ikke-alvorlige herpesinfektioner var højere i belatacept-regimerne end i ciclosporin-regimen.
English: For more details on the dose calculation, see section 6.6.
Danish: 6.6 for flere oplysninger om dosisberegning.
English: Adverse reactions resulting in interruption or discontinuation of belatacept in ≥ 1% of patients up to Year 3 were renal vein thrombosis and CMV infection.
Danish: Bivirkninger, der medførte afbrydelse eller seponering af belatacept hos ≥ 1% af patienterne op til år 3, var nyrevenetrombose og CMV-infektion.
English: Antibodies directed against the belatacept molecule were assessed in 796 kidney transplant recipients (551 of these treated for at least 3 years) in the two Phase 3 studies.
Danish: Antistoffer rettet mod belataceptmolekylet vurderedes hos 796 nyretransplantatrecipienter (hvoraf 551 blev behandlet i mindst 3 år) i de to fase 3-studier.
English: More detailed information on the benefits, risks, and precautions for usage of NULOJIX are described in the Summary of Product Characteristics (SmPC) for health care professionals and a package leaflet (PL) for patients.
Danish: Mere detaljerede oplysninger om fordele, risici og forholdsregler for brugen af NULOJIX er beskrevet i produktresumeet (SPC), som er henvendt til sundhedspersonalet og indlægssedlen (PIL), som er henvendt til patienter.
English: Lymphocyte Depleting Therapies and MPA: As the total burden of immunosuppression is a risk factor for malignancies and opportunistic infections, higher than the recommended doses of concomitant immunosuppressive agents should be avoided.
Danish: Lymfocyt-depleterende terapi og MPA: Eftersom den totale mængde immunsuppression er en risikofaktor for udvikling af maligniteter og opportunistiske infektioner, bør doser af samtidige immunsuppressiva, der overstiger det anbefalede, undgås.
English: In Study 1, one additional case of PTLD was reported in the ciclosporin group, in a patient who was EBV seropositive at the time of transplant.
Danish: I Studie 1 blev der rapporteret et yderligere tilfælde af PTLD i ciclosporingruppen hos en patient, der var EBV-seropositiv på transplantationstidspunktet.
English: Study 1 and 2: Phase 3 studies in renal transplant recipients The safety and efficacy of belatacept as part of an immunosuppressive regimen following renal transplantation were assessed in two randomised, partially-blinded, multicenter, 3 year studies with the primary endpoint specified at Year 1.
Danish: Studie 1 og 2: Fase 3-studier med nyretransplantatrecipienter Effekt og sikkerhed af belatacept som del af et immunsuppressivt regimen ved nyretransplantation er undersøgt i to randomiserede, delvist blindede, 3-årige, multicenter studier, hvor det primære endepunkt var ved år 1.
English: Patients should be evaluated for tuberculosis and tested for latent infection prior to initiating belatacept.
Danish: Patienter bør undersøges for tuberkulose og testes for latent infektion inden behandling med belatacept påbegyndes.
English: Practical details on the reconstitution of vials
Danish: Praktiske detaljer om rekonstituering af hætteglas
English: Therefore, the recommended dose of belatacept is the LI dosage regimen.
Danish: Derfor er den anbefalede dosis af belatacept den som blev anvendt i LI-regimet.
English: The safety and efficacy of belatacept have not been established in liver transplant patients, and therefore such use is not recommended.
Danish: Belatacepts sikkerhed og effekt er ikke fastlagt hos levertransplanterede patienter, og derfor frarådes brugen til denne patientgruppe.
English: These studies compared two dose regimens of belatacept (MI and LI) with ciclosporin in recipients of standard criteria (Study 1) or extended criteria (Study 2) donor organs.
Danish: Disse studier sammenlignede to dosisregimer for belatacept (MI og LI) med ciclosporin hos recipienter med donornyrer efter standardkriterier (studie 1) eller donornyrer efter extended criteria (studie 2).
English: Table 5: Key efficacy outcomes at years 1 and 3 Study 1: living and standard criteria deceased donors
Danish: Tabel 5: Nøgle effektmål ved år 1 og 3 Studie 1: Nyrer fra levende donorer og nyrer efter standardkriterier fra afdøde donorer
English: In Study 2, among patients who were EBV seropositive at the time of transplant, there was one case of PTLD in each of the three treatment groups.
Danish: I Studie 2 var der blandt patienter, der var EBV-seropositive på transplantationstidspunktet, et tilfælde af PTLD i hver af de tre behandlingsgrupper.
English: Serious infections can include Tuberculosis Cytomegalovirus (CMV), a virus that can cause serious tissue and blood infections Shingles Other herpes virus infections.
Danish: Alvorlige infektioner kan omfatte Tuberkulose Cytomegalovirus (CMV), en virus der kan medføre alvorlige infektioner i væv og blod Helvedesild Andre herpesvirusinfektioner
English: Up to month 3 post-transplantation with the recommended dosing regimen, the level of CD86 saturation was maintained at approximately 70% and at month 12, approximately 65%.
Danish: Op til 3 måneder efter transplantation med det anbefalede dosisregimen opretholdtes en CD86-mætningsgrad på ca. 70% og 65% ved 12. måned.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with belatacept in one or more subsets of the paediatric population in renal transplantation (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat kravet om fremlæggelse af resultaterne af studier med belatacept hos en eller flere undergrupper af den pædiatriske population ved nyretransplantation (se pkt.
English: PML is usually diagnosed by brain imaging, including magnetic resonance imaging (MRI) or computed tomography (CT) scan, and cerebrospinal fluid (CSF) testing for JC viral DNA by polymerase chain reaction (PCR).
Danish: PML diagnosticeres sædvanligvis ved hjernescanning, herunder magnetisk resonansscanning (MRI) eller computertomografi (CT) scanning og undersøgelse af cerebrospinalvæske (CSF) for JC-viral DNA ved polymerase kædereaktionstest (PCR).
English: Study 2 excluded recipients with a current PRA ≥ 30%, re-transplanted patients, and in case of a positive T-cell lymphocytotoxic cross match.
Danish: Studie 2 ekskluderede modtagere med eksisterende PRA ≥30%, retransplanterede patienter og i tilfælde af positiv T-celle lymfocytotoksisk crossmatch.
English: Study 2: Recipients of Extended Criteria Donor Kidneys Extended criteria donors were defined as deceased donors with at least one of the following: (1) donor age ≥ 60 years; (2) donor age ≥ 50 years and other donor comorbidities (≥ 2 of the following: stroke, hypertension, serum creatinine > 1.5 mg/dl); (3) donation after cardiac death or (4) anticipated cold ischemia time of ≥ 24 hours.
Danish: Studie 2: Recipienter til donornyrer efter extended criteria Extended criteria donorer blev defineret som afdøde donorer med mindst et af følgende kriterier: (1) donoralder ≥ 60 år; (2) donoralder ≥ 50 år og anden komorbiditet hos donor (≥ 2 af følgende: slagtilfælde, hypertension, serumkreatinin > 1,5 mg/dl); (3) donation efter hjertedød eller (4) forventet kold iskæmi-tid på ≥ 24 timer.
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.
Danish: I tilfælde af overdosis anbefales det at overvåge patienten for eventuelle tegn og symptomer på bivirkninger samt at starte relevant symptomatisk behandling.
English: The concentration of belatacept in the infusion should be between 2 mg and 10 mg belatacept per ml solution.
Danish: Den endelige koncentration af belatacept bør være mellem 2 mg og 10 mg belatacept per ml opløsning.
English: Studies in rats exposed to abatacept have shown immune system abnormalities including a low incidence of infections leading to death (juvenile rats) as well as inflammation of the thyroid and pancreas (both juvenile and adult rats).
Danish: Forsøg med rotter, der blev eksponeret for abatacept, har vist immunsystemabnormiteter herunder en lav forekomst af infektioner medførende død (unge rotter) såvel som inflammation i skjoldbruskkirtlen og bugspytkirtlen (både unge og voksne rotter).
English: Two hundred seventeen (217) patients 65 years and older received belatacept across one Phase 2 and two Phase 3 renal studies.
Danish: Tohundredeogsytten (217) patienter i alderen 65 år og ældre fik belatacept under et fase 2- og to fase 3-nyrestudier.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/694/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/694/001
English: Sodium dihydrogen phosphate monohydrate Sodium chloride
Danish: Natriumdihydrogenphosphatmonohydrat Natriumchlorid
English: Direct the stream of fluid to the glass wall of the vial and not into the powder.
Danish: Ret væskestrålen mod siden af hætteglasset og ikke på pulveret.
English: Belatacept has not been studied in patients with PRA > 30% (see section 4.2).
Danish: Belatacept er ikke undersøgt hos patienter med PRA > 30% (se pkt.
English: End of Week 8 and Week 12 after transplantation Maintenance Phase
Danish: Slutningen af uge 8 og uge 12 efter transplantation Vedligeholdelsesfasen
English: NULOJIX contains the active substance belatacept which belongs to a group of medicines called immunosuppressants.
Danish: NULOJIX indeholder det aktive stof belatacept, som tilhører medicingruppen immunsuppressiva.
English: The most frequently reported acute infusion-related reactions in combined belatacept regimens were hypotension, hypertension, flushing and headache.
Danish: De hyppigst rapporterede akutte infusionsrelaterede reaktioner i belatacept-regimerne tilsammen var hypotension, hypertension, rødme og hovedpine.
English: Year 1 and Year 3 frequencies of infections occurring by treatment group are shown in Table 4.
Danish: Hyppigheden af infektioner i år 1 og år 3, der forekom i hver behandlingsgruppe, er vist i tabel 4.
English: Any unused portion in the vials must be discarded in accordance with local requirements.
Danish: Ikke anvendt indhold i hætteglasset skal bortskaffes i henhold til lokale retningslinjer.
English: To assess for the presence of neutralising antibodies, samples from 29 patients with confirmed binding activity to the modified cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) region of the molecule were assessed by an in vitro assay; 8 (27.6%) patients were shown to possess neutralising antibodies.
Danish: For at undersøge tilstedeværelsen af neutraliserende antistoffer blev prøver fra 29 patienter med bekræftet bindingsaktivitet til det modificerede cytotoksiske T-lymfocyt-associerede antigen 4 (CTLA-4)-molekyleområde undersøgt ved en in vitro test. Otte (27,6%) patienter viste sig at have neutraliserende antistoffer.
English: This will avoid aggregate formation (see section 6.2).
Danish: Dette forhindrer aggregation (se pkt.
English: The higher proportion of deaths in the LI group in Study 2 was mainly due to neoplasms (MI: 3.8%, LI: 7.1%, ciclosporin: 2.3%).
Danish: Den højere andel af dødsfald i LI-gruppen i Studie 2 skyldtes hovedsageligt neoplasier (MI: 3,8 %; LI: 7,1 %, ciclosporin: 2,3 %).
English: 2 vials 2 syringes
Danish: 2 hætteglas 2 sprøjter
English: Belatacept, a selective costimulation blocker, is a soluble fusion protein consisting of a modified extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) fused to a portion (hinge-CH2-CH3 domains) of the Fc domain of a human immunoglobulin G1 antibody.
Danish: Den selektive costimulation-blokker belatacept er et opløseligt fusionsprotein bestående af et modificeret ekstracellulært domæne af humant cytotoksisk T-lymfocyt-associeret antigen 4 (CTLA-4) forbundet med en del (hinge-CH2-CH3-domæner) af Fc-domænet humant immunglobulin G1 antistof.
English: When belatacept was compared to placebo infusions, there were no differences in event rates (placebo infusions were administered at Weeks 6 and 10 of the belatacept LI regimen to blind the MI and LI regimens).
Danish: Ved sammenligning mellem belatacept- og placeboinfusioner var der ingen forskel på forekomsten (placeboinfusioner blev administreret i uge 6 og 10 i belatacept LI-regimen for at blinde MI- og LI-regimenerne).
English: In a single Phase 2 clinical study in de novo liver transplant patients, an increase in the number of deaths was observed in 2 of 3 belatacept-containing regimens studied.
Danish: I et enkelt klinisk fase 2-studie med de novo levertransplanterede patienter blev der observeret et øget antal dødsfald i 2 ud af de 3 undersøgte belatacept-indeholdende regimener.
English: If you have not been exposed to it, you are at a higher risk of getting a type of cancer called posttransplant lymphoproliferative disorder (PTLD).
Danish: Hvis du ikke har været smittet med den virus, har du en forhøjet risiko for at få en type kræft, der hedder post-transplantation lymfoproliferativ sygdom (PTLD).
English: The use of live vaccines should be avoided (see section 4.5).
Danish: Brugen af levende vacciner bør undgås (se pkt.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på etiketten på hætteglasset og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Overall, the few reports across clinical studies suggest that prolonged exposure to belatacept does not predispose patients to an increased risk of development of autoimmune events.
Danish: Samlet set tyder de få rapporter fra alle studier på, at patienter ikke har en øget risiko for at udvikle autoimmune hændelser ved langvarig belatatacepteksponering.
English: People who use NULOJIX have a higher risk of getting certain other types of cancer, especially skin cancer.
Danish: Patienter, der behandles med NULOJIX, har forhøjet risiko for at få visse typer kræft, især hudkræft.
English: The overall proportion of patients with death or graft loss was lower in belatacept-treated patients (MI: 11.4%, LI: 11.9%) as compared to ciclosporin-treated patients (17.6%) in Study 1.
Danish: Den samlede andel af patienter, der døde eller mistede transplantatet, var lavere blandt belataceptbehandlede patienter (MI: 11,4 % LI; 11,9 %) i sammenligning med ciclosporinbehandlede patienter (17,6 %) i Studie 1.
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: En opdateret RMP skal fremsendes: 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 risk/benefit-forholdet, eller som følge af at der er nået en vigtig milepæl (lægemiddelovervågning eller risikominimering).
English: Table 5 summarises results for belatacept LI compared with ciclosporin for the co-primary efficacy endpoints of death and graft loss, composite renal impairment, and acute rejection (defined as clinically suspected biopsy proven acute rejection).
Danish: Tabel 5 opsummerer resultaterne for belatacept LI sammenlignet med ciclosporin for de co-primære effekt endepunkter død og graftafstødning, kombineret med nedsat nyrefunktion og akut afstødning (defineret som klinisk mistænkt og biopsibekræftet akut afstødning).