natgillin/translations-raw huggingface dataset:
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. 
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.
Immunsuppressiv behandling kan påvirke effekten af vaccinen. 
Immunosuppressant therapy may affect response to vaccination.
Afhængig af hvilken type nyretransplantation du har fået foretaget, kan du have en øget risiko for at få en blodprop i den transplanterede nyre. 
Depending on the type of kidney transplant that you received, you may be at higher risk of blood clotting in your transplanted kidney.
Studier med rotter har vist, at belatacept udskilles i mælken. 
Studies in rats have shown excretion of belatacept in milk.
Med NULOJIX-behandling opstår PTLD hyppigere i hjernen og kan være dødelig. 
With NULOJIX treatment, this more often develops in the brain and can lead to death.
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. 
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.
Belatacept bindes til CD80 og CD86 på antigenpræsenterende celler. 
Belatacept binds to CD80 and CD86 on antigen presenting cells.
Du er i behandling med en kraftigt virkende medicin, der hæmmer immunsystemet. 
You are being treated with a potent medicine that suppresses the immune system.
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. 
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.
Kvinder bør ikke amme under behandling med et belatacept-baseret behandlingsregime. 
Women should not breast-feed while on treatment with a belatacept-based regimen.
Patient- og transplantatoverlevelse (%) År 1 [95% CI] 
Patient and Graft Survival (%) Year 1 [95% CI]
Farmakokinetiske populationsanalyser med nyretransplantationspatienter viste en tendens til højere clearance af belatacept med stigende kropsvægt. 
Population pharmacokinetic analyses in renal transplant patients revealed that there was a trend toward higher clearance of belatacept with increasing body weight.
Det er ikke nødvendigt, at patienter præmedicineres for at forhindre allergiske reaktioner (se pkt. 
Patients are not required to be pre-treated to prevent allergic reactions (see section 4.8).
Se listen over symptomer i afsnit 4 ”Bivirkninger”. 
For a list of symptoms please see section 4, “Possible side effects”.
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. 
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.
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. 
No clinically relevant effects of age, gender, race, renal function (calculated GFR), diabetes, or concomitant dialysis on clearance of belatacept was identified.
Må ikke bruges, hvis der er uigennemsigtige partikler, misfarvning eller andre fremmedlegemer til stede. 
Do not use if opaque particles, discolouration or other foreign particles are present.
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. 
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.
Baseret på en farmakokinetisk populationsanalyse af 944 nyretransplantationspatienter op til 1 år efter transplantation var belatacepts farmakokinetik ens i de forskellige perioder efter transplantation. 
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.
Den anbefalede dosis afhænger af din vægt (i kg) og bliver beregnet af en læge eller sygeplejerske. 
The recommended dose is based on your body weight (in kg) and will be calculated by a healthcare professional.
Transplantationspatienter som er Epstein-Barr-virus (EBV) seronegative eller hvis serostatus er ukendt. 
Transplant recipients who are Epstein-Barr virus (EBV) seronegative or serostatus unknown.
I Studie 2, blev der observeret en reduktion på ca. 40 % j denne risiko blandt patienter i belataceptgrupperne sammenlignet med patienter i ciclosporingruppen. 
In Study 2, approximately 40% reduction in this risk was observed among patients in the belatacept groups as compared with those assigned to ciclosporin.
Af de 6 tilfælde af PTLD i LI-gruppen omfattede 3 CNS og havde dødelig udgang. 
Of the 6 PTLD cases in the LI regimen, 3 involved the CNS and were fatal.
Du bør begrænse din udsættelse for sollys og ultraviolet (UV) lys, så længe du er i behandling med NULOJIX. 
Limit your exposure to sunlight and ultraviolet (UV) light whilst using NULOJIX.
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. 
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.
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. 
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).
Hvis du bliver gravid, mens du behandles med NULOJIX, skal du informere lægen. 
If you become pregnant while using NULOJIX, tell your doctor.
Samtidig anvendelse af andre immunsuppressiva 
Use with other immunosuppressive medicines
Der er teoretiske overvejelser om, at behandling med belatacept kan øge risikoen for autoimmune processer (se pkt. 
There is a theoretical concern that treatment with belatacept might increase the risk of autoimmune processes (see section 4.8).
En sjælden type hjerneinfektion kaldet progressiv multifokal leukoencefalopati (PML) er blevet rapporteret hos patienter, der har fået NULOJIX. 
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.
Spørg lægen eller på apoteket, før du tager nogen som helst anden form for medicin, mens du behandles med NULOJIX. 
Ask your doctor or pharmacist for advice before taking any other medicine while using NULOJIX.
Bivirkningsprofilen for immunsuppressiva er ofte vanskelig at fastlægge på grund af den underliggende sygdom og den samtidige brug af forskellige andre lægemidler. 
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.
Belatacept er et fusionsprotein fremstillet i ovarieceller fra kinesiske hamstre ved hjælp af rekombinant DNA-teknologi. 
Belatacept is a fusion protein produced in Chinese hamster ovary cells by recombinant DNA technology.
Ved konstateret PML anbefales reduktion eller seponering af immunsuppressiva under hensyntagen til risikoen for transplantatet. 
If PML is diagnosed, reduction or withdrawal of immunosuppression is recommended taking into account the risk to the graft.
I det kliniske program for belatacept blev 2 patienter diagnosticeret med PML. 
Within the belatacept clinical program, there were 2 patients diagnosed with PML.
Op til år 3* 
Up to Year 3*
Kortet, hvis tekst er inkluderet i Anneks III, skal være indeholdt i alle pakninger. 
This card should be provided in each pack, the text of which is included in Annex III.
Ældre patienter viste overensstemmelse med den samlede studiepopulation med hensyn til sikkerhed og effekt vurderet ud fra patient- og transplantatoverlevelse, nyrefunktion og akut afstødning. 
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.
Smerter ved vandladning, blod i urinen 
Pain when passing urine, blood in the urine
EBV-serologien bør være klarlagt inden administration af belatacept. 
EBV serology should be ascertained before starting administration of belatacept.
Belatacept påvirker i mindre grad evnen til at føre motorkøretøj eller betjene maskiner, eftersom det kan medføre træthed, utilpashed og/eller kvalme. 
Belatacept has a minor influence on the ability to drive and use machines since it may cause fatigue, malaise and/or nausea.
Kontakt straks lægen, hvis du eller din familie bemærker et af følgende: 
Tell your doctor immediately if you or your family notice any symptoms listed below:
Inflammation i maven og tarmene, som oftest forårsaget af en virus Maveproblemer 
Inflammation of the stomach and intestines, usually caused by a virus Upset stomach
Information til læger og sundhedspersonale om beregning af dosis, klargøring og indgivelse af NULOJIX er anført sidst i indlægssedlen. 
Information for medical and healthcare professionals on dose calculation, preparation and administration of NULOJIX is provided at the end of the leaflet.
**Gennemsnitlig follow-up for PTLD for puljede studier er 1199 dage for MI, 1206 dage for LI og 1139 dage for ciclosporin. 
**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.
Uåbnede hætteglas 3 år. 
Unopened vials 3 years
Belatacepts farmakokinetik var lineær og eksponeringen for belatacept steg proportionelt hos raske forsøgspersoner efter en enkelt intravenøs infusionsdosis på 1 til 20 mg/kg. 
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.
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. 
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.
Behandling med NULOJIX vil blive ordineret og overvåget af en speciallæge i nyretransplantationer. 
Treatment with NULOJIX will be prescribed and supervised by a specialist in kidney transplantation.
Der foreligger ingen data om belatacepts effekt på human fertilitet. 
There are no data on use of belatacept and effect on fertility in humans.
Din krop kan afstøde den transplanterede nyre, hvis du holder op med NULOJIX. 
Your body may reject the transplanted kidney if you stop using NULOJIX.
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. 
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).
Svampeinfektioner Tuberkulose 
Fungal infections Tuberculosis
Der er observeret overdødelighed og transplantattab i belatatacept LI + MMF-gruppen og der er observeret overdødelighed i belatacept MI + MMF-gruppen. 
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.
Adækvat behandling af latent tuberkuloseinfektion bør iværksættes inden behandling med belatacept. 
Adequate treatment of latent tuberculosis infection should be instituted prior to belatacept use.
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. 
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.
Minimal systemisk akkumulation af belatacept opstod efter flere infusioner på 5 eller 10 mg/kg doser hos nyretransplantationspatienter hver 4. uge. 
Minimal systemic accumulation of belatacept occurred upon multiple infusions of 5 or 10 mg/kg doses in renal transplant patients every 4 weeks.
Tabel 3: Forekomst af maligniteter i de enkelte behandlingsgrupper (%) Op til år 1 
Table 3: Malignancies occurring by treatment group (%) Up to Year 1
Som følge heraf blokkere belatacept den CD28-medierede costimulation af T-celler og hæmmer derved deres aktivitet. 
As a result, belatacept blocks CD28 mediated co-stimulation of T cells inhibiting their activation.
Tag altid al medicin nøjagtigt efter lægens anvisning. 
Take all medicines as instructed by your doctor.
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. 
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.
De kan medføre afstødning af din transplanterede nyre. 
They may cause rejection of your transplanted kidney.
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. 
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).
Den samlede forekomst af tuberkuloseinfektioner og ikke-alvorlige herpesinfektioner var højere i belatacept-regimerne end i ciclosporin-regimen. 
The overall occurrence of tuberculosis infections and non-serious herpes infections were higher for belatacept regimens than for the ciclosporin regimen.
6.6 for flere oplysninger om dosisberegning. 
For more details on the dose calculation, see section 6.6.
Bivirkninger, der medførte afbrydelse eller seponering af belatacept hos ≥ 1% af patienterne op til år 3, var nyrevenetrombose og CMV-infektion. 
Adverse reactions resulting in interruption or discontinuation of belatacept in ≥ 1% of patients up to Year 3 were renal vein thrombosis and CMV infection.
Antistoffer rettet mod belataceptmolekylet vurderedes hos 796 nyretransplantatrecipienter (hvoraf 551 blev behandlet i mindst 3 år) i de to fase 3-studier. 
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.
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. 
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.
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. 
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.
I Studie 1 blev der rapporteret et yderligere tilfælde af PTLD i ciclosporingruppen hos en patient, der var EBV-seropositiv på transplantationstidspunktet. 
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.
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. 
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.
Patienter bør undersøges for tuberkulose og testes for latent infektion inden behandling med belatacept påbegyndes. 
Patients should be evaluated for tuberculosis and tested for latent infection prior to initiating belatacept.
Praktiske detaljer om rekonstituering af hætteglas 
Practical details on the reconstitution of vials
Derfor er den anbefalede dosis af belatacept den som blev anvendt i LI-regimet. 
Therefore, the recommended dose of belatacept is the LI dosage regimen.
Belatacepts sikkerhed og effekt er ikke fastlagt hos levertransplanterede patienter, og derfor frarådes brugen til denne patientgruppe. 
The safety and efficacy of belatacept have not been established in liver transplant patients, and therefore such use is not recommended.
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). 
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.
Tabel 5: Nøgle effektmål ved år 1 og 3 Studie 1: Nyrer fra levende donorer og nyrer efter standardkriterier fra afdøde donorer 
Table 5: Key efficacy outcomes at years 1 and 3 Study 1: living and standard criteria deceased donors
I Studie 2 var der blandt patienter, der var EBV-seropositive på transplantationstidspunktet, et tilfælde af PTLD i hver af de tre behandlingsgrupper. 
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.
Alvorlige infektioner kan omfatte Tuberkulose Cytomegalovirus (CMV), en virus der kan medføre alvorlige infektioner i væv og blod Helvedesild Andre herpesvirusinfektioner 
Serious infections can include Tuberculosis Cytomegalovirus (CMV), a virus that can cause serious tissue and blood infections Shingles Other herpes virus infections.
Op til 3 måneder efter transplantation med det anbefalede dosisregimen opretholdtes en CD86-mætningsgrad på ca. 70% og 65% ved 12. måned. 
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%.
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. 
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).
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). 
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).
Studie 2 ekskluderede modtagere med eksisterende PRA ≥30%, retransplanterede patienter og i tilfælde af positiv T-celle lymfocytotoksisk crossmatch. 
Study 2 excluded recipients with a current PRA ≥ 30%, re-transplanted patients, and in case of a positive T-cell lymphocytotoxic cross match.
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. 
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.
I tilfælde af overdosis anbefales det at overvåge patienten for eventuelle tegn og symptomer på bivirkninger samt at starte relevant symptomatisk behandling. 
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.
Den endelige koncentration af belatacept bør være mellem 2 mg og 10 mg belatacept per ml opløsning. 
The concentration of belatacept in the infusion should be between 2 mg and 10 mg belatacept per ml solution.
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). 
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).
Tohundredeogsytten (217) patienter i alderen 65 år og ældre fik belatacept under et fase 2- og to fase 3-nyrestudier. 
Two hundred seventeen (217) patients 65 years and older received belatacept across one Phase 2 and two Phase 3 renal studies.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/11/694/001 
MARKETING AUTHORISATION NUMBER(S) EU/1/11/694/001
Natriumdihydrogenphosphatmonohydrat Natriumchlorid 
Sodium dihydrogen phosphate monohydrate Sodium chloride
Ret væskestrålen mod siden af hætteglasset og ikke på pulveret. 
Direct the stream of fluid to the glass wall of the vial and not into the powder.
Belatacept er ikke undersøgt hos patienter med PRA > 30% (se pkt. 
Belatacept has not been studied in patients with PRA > 30% (see section 4.2).
Slutningen af uge 8 og uge 12 efter transplantation Vedligeholdelsesfasen 
End of Week 8 and Week 12 after transplantation Maintenance Phase
NULOJIX indeholder det aktive stof belatacept, som tilhører medicingruppen immunsuppressiva. 
NULOJIX contains the active substance belatacept which belongs to a group of medicines called immunosuppressants.