FrancophonIA/ELRC3.0 huggingface dataset:
English: <Invented name> is routinely administered in conjunction with other immunosuppressive agents in the initial post-operative period.
Danish: <[(Sær)navn]> administreres rutinemæssigt med andre immunosuppressive midler i den første postoperative periode.
English: The <Invented name> dose may vary depending upon the immunosuppressive regimen chosen.
Danish: Doseringen af <[(Sær)navn]> kan variere afhængig af det valgte immunosuppressive regime.
English: There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall.
Danish: Det er også vist gastrointestinal metabolisme via CYP3A4 i den intestinale væg.
English: Accordingly, high-risk patients, particularly young children and those receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG preand post-transplant (e.g. initially at three months and then at 9-12 months).
Danish: Derfor skal patienter i risikogruppen, specielt små børn og patienter i intensiv immunosuppression kontrolleres med f.eks. ekkokardiografi eller EKG før og efter transplantation (f.eks. initialt, efter 3 måneder og igen efter 9-12 måneder).
English: When dosed orally, blood trough levels should be drawn approximately 12 hours post-dosing, just prior to the next dose.
Danish: Ved peroral dosering bør blodprøverne tages ca. 12 timer efter kapselindtagelse, umiddelbart før næste dosis.
English: Tacrolimus is a low-clearance substance.
Danish: Tacrolimus har en lav clearance.
English: Other allografts (lung, pancreas and intestines)
Danish: Andre allotransplantater (lunge, pancreas og tarme)
English: ANNEX III SUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG III PRODUKTRESUME
English: The frequency of blood level monitoring should be based on clinical needs.
Danish: Hyppigheden af målinger afhænger af det kliniske behov.
English: Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking <Invented name>.
Danish: Kør ikke bil eller brug værktøj eller maskiner hvis De føler dig svimmel eller søvnig eller har problemer med at se klart efter De har taget <[(Sær)navn]>.
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the halflife of pentobarbital and antipyrine.
Danish: Data fra dyrestudier har vist at tacrolimus kunne nedsætte clearance og forøge halveringstiden af pentobarbital og antipyrin.
English: Conversion from ciclosporin
Danish: Skift fra behandling med ciclosporin
English: Human data show that tacrolimus is able to cross the placenta.
Danish: Humane data viser, at tacrolimus er i stand til at passere placenta.
English: Duration of dosing
Danish: Varighed af dosering
English: Astellas Pharma Co. Ltd. 25, The Courtyard Kilcarbery Business Park Clondalkin, Dublin 22 Ireland
Danish: Astellas Pharma Co. Ltd. 25, The Courtyard Kilcarbery Business Park Clondalkin, Dublin 22 Irland
English: In practice, <Invented name> therapy has been initiated 12 - 24 hours after discontinuation of ciclosporin.
Danish: I praksis kan behandling med <[(Sær)navn]> starte 12 - 24 timer efter ophør af ciclosporinbehandlingen.
English: - If you have liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of <Invented name> that you receive.
Danish: - Hvis De har leverproblemer eller har haft en lidelse som kan have påvirket din lever skal De oplyse din læge om dette, da det kan påvirke doseringen af <[(Sær)navn]>.
English: In total 34 patients switched treatment from ciclosporin to tacrolimus, whereas only 6 tacrolimus patients required alternative therapy (Bechstein et al., Transplantation 2004;77:1221).
Danish: I alt 34 patienter skiftede behandling fra ciclosporin til tacrolimus, medens kun 6 tacrolimuspatienter havde behov for a alternativ behandling (Bechstein et al., Transplantation 2004;77:1221) Intestinal transplantation
English: The efficacy of tacrolimus for kidney transplantation has been investigated in a number of studies and different regimens and can nowadays be regarded as a well-established treatment option, both for primary immunosuppression and for rescue therapy.
Danish: Virkningen af tacrolimus ved nyretransplantation er undersøgt gennem en række undersøgelser og behandlinger og kan i dag betragtes som en almindelig anerkendt behandlingsmetode, både til primær immunosuppression og som livsreddende behandling.
English: In healthy subjects, the average total body clearance (TBC) estimated from whole blood concentrations was 2.25 l/h.
Danish: Hos raske forsøgspersoner var den gennemsnitlige totale body clearance (TBC) beregnet fra fuldblodskoncentrationer 2,25 l/time.
English: In the early years the initial oral dose of tacrolimus was 0.3 mg/kg/day.
Danish: I de første år var den initiale perorale dosis af tacrolimus 0,3 mg/kg/dag.
English: Fujisawa GmbH acting on behalf of all Marketing Authorisation holders (see Annex I) has applied for harmonisation according to Article 30 of Directive 2001/83/EC, as amended, of their products Prograf and associated names 0.5, 1 and 5 mg hard capsules (oral use) and Prograf and associated names 5 mg/ml concentrate for infusion (intravenous use).
Danish: Fujisawa GmbH har på vegne af alle indehavere af markedsføringstilladelser (se bilag I) begæret harmonisering efter artikel 30 i direktiv 2001/83/EF, som ændret, for produkterne Prograf og tilknyttede navne i form af hårde kapsler, 0,5, 1 og 5 mg (oral anvendelse) samt Prograf og tilknyttede navne i form af koncentrat til infusionsvæske (intravenøs anvendelse), 5 mg/ml.
English: If you receive more <Invented name> than you should If you have received too much <Invented name>, your doctor will amend your next dose.
Danish: Hvis De anvender mere <[(Sær)navn]> end De bør Hvis De ved en fejltagelse har fået for meget <[(Sær)navn]> vil din læge justere den næste dosis.
English: Even the trials in liver and kidney transplantation were of only moderate size.
Danish: Selv forsøgene med lever- og nyretransplantation er kun af moderat størrelse.
English: Read all of this leaflet carefully before you start using this medicine.
Danish: Læs hele denne indlægsseddel omhyggeligt, inden De begynder at anvende dette lægemiddel.
English: As the pharmacokinetics of tacrolimus are unaffected by renal function, no dose adjustment should be required.
Danish: Da tacrolimus farmakokinetik er uafhængig af nyrefunktionen bør dosisjustering ikke være nødvendig.
English: In healthy subjects, the mean half-life in whole blood is approximately 43 hours.
Danish: Hos raske forsøgspersoner er middelværdien for halveringstiden i fuldblod ca. 43 timer.
English: Method of administration
Danish: Administrationsmåde
English: Grapefruit juice has been reported to increase the blood level of tacrolimus and should therefore be avoided.
Danish: Det er rapporteret at grapefrugtjuice øger koncentrationen af tacrolimus, hvorfor det bør undgås.
English: It would seem appropriate to recognise the de facto situation that tacrolimus is used in primary and rescue situations as an immunosupressant in liver transplantation and grant an appropriate therapeutic indication.
Danish: Det synes derfor hensigtsmæssigt at tage til efterretning, at tacrolimus de facto anvendes som primær behandling og livsreddende behandling til immunosuppression ved levertransplantation, og at godkende en passende terapeutisk indikation.
English: After oral administration (0.30 mg/kg/day) to liver transplant patients, steady-state concentrations of <Invented name> were achieved within 3 days in the majority of patients.
Danish: Efter peroral administrering (0,30 mg/kg/dag) til levertransplanterede patienter opnåede flertallet steady-state koncentrationer of <[(Sær)navn]> i løbet af 3 dage.
English: Since levels of tacrolimus in blood may significantly change during diarrhoea episodes, extra monitoring of tacrolimus concentrations is recommended during episodes of diarrhoea.
Danish: Da blodets indhold af tacrolimus kan ændres signifikant efter diarré, anbefales ekstra monitorering af tacrolimuskoncentrationerne i forbindelse med diarré.
English: Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ-interferon) and the expression of the interleukin-2 receptor.
Danish: Tacrolimus hæmmer T-celleaktivering og T-hjælpercelle afhængig Bcelleproliferation, samt dannelsen af lymfokiner (såsom interleukin-2 og -3 og γ-interferon) og nedreguleringen af interleukin-2 receptorer.
English: In prospective published studies tacrolimus was investigated as primary immunosuppressant in approximately 175 patients following lung, 475 patients following pancreas and 630 patients following intestinal transplantation.
Danish: I publicerede prospektive studier var tacrolimus primært immunosuppressivum i omkring 175 lungetransplanterede patienter, 475 pancreastransplanterede patienter og 630 intestinaltransplanterede patienter.
English: These effects are more frequently observed if <Invented name> is taken in conjunction with alcohol use.
Danish: Virkningerne ses oftere hvis <[(Sær)navn]> tages sammen med alkohol.
English: Following oral administration of <Invented name> capsules peak concentrations (Cmax) of tacrolimus in blood are achieved in approximately 1 - 3 hours.
Danish: Efter peroral administrering af <[(Sær)navn]> kapsler ses peak blodkoncentrationer (Cmax) af tacrolimus efter omkring 1-3 timer.
English: The clinical trials conducted in indications other than liver and kidney transplantation have been quite small and seem to have been investigator driven rather then driven by the MAH.
Danish: De kliniske forsøg med andre indikationer end lever- og nyretransplantation har været ganske små og synes snarere udført på undersøgerens end på registreringsindehaverens foranledning.
English: <Invented name> should be used for intravenous infusion only after it is diluted.
Danish: <[(Sær)navn]> må kun anvendes til intravenøs infusion efter fortynding.
English: Tacrolimus is widely metabolised in the liver, primarily by the cytochrome P450-3A4.
Danish: Tacrolimus metaboliseres i udstrakt grad i leveren, primært af cytochrom P450-3A4.
English: Published clinical experience from a single centre on the use of tacrolimus for primary treatment following intestinal transplantation showed that the actuarial survival rate of 155 patients (65 intestine alone, 75 liver and intestine, and 25 multivisceral) receiving tacrolimus and prednisone was 75% at 1 year, 54% at 5 years, and 42% at 10 years.
Danish: Publicerede kliniske resultater fra et enkelt center om brug af tacrolimus som primær behandling efter intestinale transplantationer viste at overlevelsesraten af 155 patienter (65 intestinal alene, 75 lever og tarm og 25 multivicerale) der fik tacrolimus og prednisolon var 75% efter 1 år, 54% efter 5år og 42% efter 10 år.
English: Heart transplantation in adults:
Danish: Hjertetransplantation hos voksne:
English: Reversible cardiotoxic effects were observed in rabbits following intravenous administration of tacrolimus.
Danish: Der sås reversible kardiotoksiske effekter hos kaniner efter intravenøs tacrolimus.
English: Grapefruit and grapefruit juice should be avoided while taking <Invented name>.
Danish: Grapefrugt og grapefrugtjuice skal undgås under behandling med <[(Sær)navn]>.
English: Dose adjustment during post-transplant period in adults and children <Invented name> doses are usually reduced in the post-transplant period.
Danish: Dosisjustering i perioden efter transplantation hos voksne og børn Doseringen af <[(Sær)navn]> bliver sædvanligvis reduceret i løbet af perioden efter transplantationen.
English: Blood trough levels should be monitored approximately twice weekly during the early post-transplant period and then periodically during maintenance therapy.
Danish: Dalkoncentrationerne bør måles ca. 2 gange om ugen i den første tid efter operationen og derefter regelmæssigt med længere intervaller under vedligeholdelsesbehandlingen.
English: dehydration, reduced protein or sugar in the blood, increased phosphate in the blood
Danish: dehydrering, nedsat protein og sukker i blodet, øget fosfat i blodet
English: Less than 1% of unchanged tacrolimus was detected in the urine and faeces, indicating that tacrolimus is almost completely metabolised prior to elimination: bile being the principal route of elimination.
Danish: Mindre end 1% af intakt tacrolimus blev fundet i urin og fæces, hvilket indicerer at næsten al tacrolimus metaboliseres før eliminering idet størstedelen bliver elimineret med galden.
English: In stable liver transplant patients, the oral bioavailability of <Invented name> was reduced when it was administered after a meal of moderate fat (34% of calories) content.
Danish: Hos stabile levertransplanterede patienter, er den perorale biotilgængelighed reduceret når <[(Sær)navn]> administreres efter et måltid med moderat fedtindhold (34% af kalorierne).
English: Tacrolimus is also considerably metabolised in the intestinal wall.
Danish: Tacrolimus metaboliseres også betydeligt i tarmvæggen.
English: Decreases in AUC (27%) and Cmax (50%), and an increase in tmax (173%) in whole blood were evident.
Danish: Der var et fald i AUC (27%) og i Cmax (50%) og en øgningen af tmax (173%) i fuldblod.
English: Paediatric liver transplant recipients have a TBC approximately twice that of adult liver transplant patients.
Danish: Levertransplanterede børn har en TBC, der er ca. det dobbelte af værdien hos voksne levertransplanterede.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION [To be completed nationally]
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN [Udfyldes nationalt]
English: Decreases in AUC (2 to 12%) and Cmax (15 to 38%), and an increase in tmax (38 to 80%) in whole blood were evident.
Danish: Der var et fald i AUC (2-12%) og Cmax (15-38%) og en øgning af tmax (38-80%) i fuldblod.
English: The 1-year survival rates were 73.1% in the tacrolimus versus 79.2% in the ciclosporin group.
Danish: 1-års overlevelsesrater var 73,1% i tacrolimusgruppen versus 79,2% i ciclosporingruppen.
English: A multicentre study included 205 patients undergoing simultaneous pancreas-kidney transplantation who were randomised to tacrolimus (n=103) or to ciclosporin (n=102).
Danish: Et multicenter studie, hvori der indgik 205 patienter, der gennemgik simultan pancreasnyretransplantation blev randomiseret til tacrolimus (n=103) eller til ciclosporin (n=102).
English: Via delle Industrie 1 20061 Carugate (Milano) Italy
Danish: Astellas Pharma S.p.A Via delle Industrie 1 20061 Carugate (Milano) Italien
English: Clinical study analysis suggests that the majority of patients can be successfully managed if tacrolimus blood trough levels are maintained below 20 ng/ml.
Danish: Kliniske undersøgelser viser, at behandlingen af de fleste patienter forløber godt, hvis blodkoncentrationerne holdes under 20 ng/ml.
English: Significantly more ciclosporin-treated patients (n = 13) required a switch to tacrolimus than tacrolimus-treated patients to ciclosporin (n = 2) (p = 0.02) (Keenan et al., Ann Thoracic Surg 1995;60:580).
Danish: Signifikant flere patienter i ciclosporingruppen (n=13) måtte overføres til tacrolimus end tacrolimusbehandlede patienter, der måtte overføres til ciclosporin (n=2) (p=0,02) (Keenan et al.; Ann Thoracic Surg 1995; 60:580).
English: In adult liver, kidney and heart transplant patients, values of 4.1 l/h, 6.7 l/h and 3.9 l/h, respectively, have been observed.
Danish: Hos voksne lever- ,nyre- og hjertetransplanterede har man set værdier på henholdsvis 4,1 l/time, 6,7 l/time og 3,9 l/time.
English: The 1-year patient survival was 83% in the tacrolimus and 71% in the ciclosporin group, the 2-year survival rates were 76% and 66%, respectively.
Danish: 1-års patientoverlevelsesraten var 83% i tacrolimusgruppen og 71% i ciclosporingruppen, 2-års patientoverlevelsen var henholdsvis 76% og 66%.
English: The 1-year patient survival rate was 80.8% in the tacrolimus and 83% in the ciclosporin group (Treede et al., 3rd ICI San Diego, US, 2004;Abstract 22).
Danish: 1-års patientoverlevelsesraten var 80,8% i tacrolimusgruppen og 83% i ciclosporingruppen (Treede et al., 3rd ICISan Diego; US, 2004, Abstract 22).
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: - Hvis en bivirkning bliver alvorlig eller De bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek.
English: EXPIRY DATE EXP: {MM/YYYY}
Danish: UDLØBSDATO EXP: {MM/YYYY}
English: Metabolic interactions
Danish: Metaboliske interaktioner
English: The half-life of ciclosporin is prolonged when tacrolimus is given concomitantly.
Danish: Ciclosporinets halveringstid er forlænget ved samtidig administrering af tacrolimus.
English: acute respiratory distress syndrome Gastrointestinal disorders very common:
Danish: akut respiratory distress syndrom Gastrointestinale sygdomme Meget almindelig:
English: Tacrolimus may cause visual and neurological disturbances.
Danish: [(Sær)navn] kan give visuelle og neurologiske forstyrrelser.
English: The interim analysis of a recent multicentre study discussed 110 patients who underwent 1:1 randomisation to either tacrolimus or ciclosporin.
Danish: Interimanalysen af et nyligt afsluttet multicenterstudie omfatter 110 patienter der blev randomiseret i forholdet 1:1 til enten tacrolimus eller ciclosporin.
English: thrombotic thrombocytopenic purpura, hypoprothrombinaemia Immune system disorders
Danish: thrombotic thrombocytopenic purpura, hypothrombopeni Forstyrrelser i immunsystemet
English: Overall, the safety profile of tacrolimus in these published studies appeared to be similar to what was reported in the large studies, where tacrolimus was used as primary treatment in liver, kidney and heart transplantation.
Danish: Tacrolimus tolerabilitet i disse publicerede studier svarer til hvad der blev rapporteret fra store studier, hvor tacrolimus blev benyttet til primær behandling efter lever, nyre og hjerte transplantationer.
English: In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly responsible for graft rejection.
Danish: Tacrolimus hæmmer specielt dannelsen af cytotoksiske lymfocytter, som er hovedansvarlig for transplantat afstødning.
English: Using <Invented name> with food and drink Grapefruit and grapefruit juice should be avoided while using <Invented name>.
Danish: Hvordan man anvender <[(Sær)navn]> sammen med mad og drikkevarer Grapefrugt og grapefrugtjuice skal undgås under behandling med <[(Sær)navn]>.
English: Patients switched to <Invented name> therapy should not receive antilymphocyte treatment concomitantly.
Danish: Patienter, der overgår til behandling med <[(Sær)navn]> bør ikke samtidigt få antilymfocytbehandling.
English: Section on undesirable effects (4.8) was brought in line with the guideline on summary of product characteristics.
Danish: Afsnittet Bivirkninger (4.8) er bragt i overensstemmelse med retningslinjen for udarbejdelse af produktresuméer.
English: Excretion Following intravenous and oral administration of 14C-labelled tacrolimus, most of the radioactivity was eliminated in the faeces.
Danish: Efter peroral og efter intravenøs administrering af 14C-mærket tacrolimus blev størstedelen af radioaktiviteten elimineret i fæces.
English: increased blood pressure common:
Danish: forhøjet blodtryk
English: The rate and extent of absorption of tacrolimus is greatest under fasted conditions.
Danish: Både hastighed og absorberet mængde tacrolimus er størst i fastende tilstand.
English: Enhanced nephrotoxicity has been observed following the administration of amphotericin B and ibuprofen in conjunction with tacrolimus.
Danish: Øget nefrotoksicitet er set ved samtidig administrering af amphotericin B eller ibuprofen sammen med tacrolimus.
English: • the Summary of Products Characteristic, Labelling and Package Leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: som indehaveren af markedsføringstilladelsen har foreslået, er blevet vurderet på grundlag af den forelagte dokumentation og de faglige drøftelser i udvalget,
English: The FKBP12-tacrolimus complex specifically and competitively binds to and inhibits calcineurin, leading to a calcium-dependent inhibition of T-cell signal transduction pathways, thereby preventing transcription of a discrete set of lymphokine genes.
Danish: FKBP12-tacrolimus komplekset bindes specifikt, kompetitivt hæmmende til calcineurin, hvilket medfører en calciumafhængig hæmning af T-cellernes signaltransduktion, således at transkriptionen af visse lymfokingener forhindres.
English: fat tissue increased
Danish: øget fedtvæv
English: Neoplasms benign, malignant and unspecified
Danish: Godartede, ondartede og uspecificerede svulster
English: Several amendments to the SPC were introduced, in particular pertaining clinical indications (4.1) and the section on posology and method of administration (4.2).
Danish: Der er foretaget flere ændringer i produktresuméet, specielt i afsnittet Terapeutiske indikationer (4.1) og afsnittet Dosering og indgivelsesmåde (4.2).
English: Obliterative bronchiolitis developed in 21.7% of patients in the tacrolimus group compared with 38.0% of patients in the ciclosporin group (p = 0.025).
Danish: Man så obliterativ bronchiolitis i 21,7% af patienterne i tacrolimus sammenlignet med 38,0% af patienterne i ciclosporingruppen (p=0,025).
English: A wording modification was introduced to section on pregnancy and lactation (4.6) in order to add clarity and to put it in line with the guideline on summary of product characteristics.
Danish: Ordlyden er ændret i afsnittet Graviditet og amning (4.6) for at gøre teksten klarere og bringe afsnittet i overensstemmelse med retningslinjen for udarbejdelse af produktresuméer.
English: Acute rejection episodes per 100 patient-days were numerically fewer in the tacrolimus (0.85 episodes) than in the ciclosporin group (1.09 episodes).
Danish: Akutte afstødningsepisoder per 100 patientdage var numerisk færre i tacrolimusgruppen (0,85 episoder) mod (1,09 episoder) i ciclosporingruppen.
English: Maintenance doses of corticosteroids have been shown to reduce tacrolimus blood levels.
Danish: Vedligeholdelsesdoser af kortikosteroider reducerer tacrolimus blodkoncentration.
English: The first dose of oral therapy should be 0.30 mg/kg/day starting 8 to 12 hours after discontinuing intravenous therapy.
Danish: Den første perorale dosis bør være 0,30 mg/kg/dag med start 8 - 12 timer efter afslutning af den intravenøse behandling.
English: Results from published data in other primary organ transplantation <Invented name> has evolved into an accepted treatment as primary immunosuppressive medicinal product following pancreas, lung and intestinal transplantation.
Danish: Resultater fra publicerede data fra anden primær organtransplantation <[(Sær)navn]> er blevet en accepteret behandling som primært immunosuppressivum i forbindelse med pancreas, lunge og intestinale transplantationer.
English: A variety of innovations, such as techniques for early detection of Epstein-Barr (EBV) and CMV infections, bone marrow augmentation, the adjunct use of the interleukin-2 antagonist daclizumab, lower initial tacrolimus doses with target trough levels of 10 to 15 ng/ml, and most recently allograft irradiation were considered to have contributed to improved results in this indication over time (AbuElmagd et al., Ann Surg 2001;234:404).
Danish: Forskellige innovationer som teknik til tidlig diagnose af Epstein-Bar (EBV) og CMV infektioner, knoglemarvs forøgelse, samtidig brug af interleukin-2 antagonisten daclizumab, lavere initiale doser af tacrolimus med dalkoncentrationer på 10-15 ng/ml og senest allotransplantat bestråling, har bidraget til at forbedre resultaterne ved denne indikation (Abu-Elmagd et al., Ann Surg 2001;234:404).