FrancophonIA/ELRC3.0 huggingface dataset:
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 en nyligt afsluttet multicenterundersøgelse omfatter 110 patienter, der blev randomiseret i forholdet 1:1 til enten tacrolimus eller ciclosporin.
English: Decreases in AUC (27%) and Cmax (50%), and an increase in tmax (173%) in whole blood were evident.
Danish: Der er desuden et fald i AUC (27 %) og i Cmax (50 %) og en øgning af tmax (173 %) i fuldblod.
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: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/.
Danish: Yderligere information om Modigraf findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Clinical data suggest that the pharmacokinetics of statins are largely unaltered by the co-administration of tacrolimus.
Danish: Kliniske data tyder på, at statinernes farmakokinetik stort set er uændret ved samtidig administration af tacrolimus.
English: pure red cell aplasia, agranulocytosis, haemolytic anaemia
Danish: pure red cell aplasia, agranulocytose, hæmolytisk anæmi
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: Obliterativ bronchiolitis blev observeret hos 21,7 % af patienterne i tacrolimusgruppen sammenlignet med 38,0 % af patienterne i ciclosporingruppen (p=0,025).
English: The liquid should be drunk immediately after preparation.
Danish: Væsken bør drikkes umiddelbart efter fremstillingen.
English: Following oral administration of Modigraf granules peak concentrations (Cmax) of tacrolimus in blood are on average achieved in approximately 2 to 2.5 hours.
Danish: Efter oral administration af Modigrafgranulat opnås den maksimale blodkoncentration for tacrolimus gennemsnitligt efter ca. 2-2,5 timer.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ (E)
English: Blood and lymphatic system disorders common:
Danish: Blod- og lymfesystem Almindelig:
English: It is an immunosuppressant.
Danish: Det er immundæmpende medicin.
English: No specific antidote to tacrolimus therapy is available.
Danish: Der findes ingen specifik antidot til behandling med tacrolimus.
English: Therefore, metabolites do not contribute to pharmacological activity of tacrolimus.
Danish: Derfor bidrager metabolitter ikke til tacrolimus' farmakologiske effekt.
English: Other potential interactions that may increase systemic exposure of tacrolimus include prokinetic agents (such as metoclopramide and cisapride), cimetidine and magnesium-aluminium-hydroxide.
Danish: Andre potentielle interaktioner, som kan medføre en øget systemisk eksponering for tacrolimus, er prokinetiske midler (såsom metoclopramid og cisaprid), cimetidin og magnesium-aluminium-hydroxid.
English: In prospective published studies oral tacrolimus (given as Prograf capsules) 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 undersøgelser blev oral tacrolimus (givet som Prograf-kapsler) undersøgt som primært immunsuppressivum hos omkring 175 lungetransplanterede patienter, 475 pancreastransplanterede patienter og 630 intestinaltransplanterede patienter.
English: Astellas Ireland Co. Ltd. Killorglin
Danish: Astellas Irland Co. Ltd. Killorglin
English: In rats, female reproductive function including birth was impaired at toxic doses and the offspring showed reduced birth weights, viability and growth.
Danish: Hos hunrotter blev den reproduktive funktion herunder fødsel nedsat ved toksiske doser, og der sås lavere fødselsvægt, levedygtighed og vækst hos afkommet.
English: Dose reduction may be necessary in patients with severe liver impairment (See section 4.2).
Danish: Det kan være nødvendigt at reducere dosis hos patienter med kraftigt nedsat leverfunktion (se pkt.
English: Human data demonstrate that tacrolimus is excreted into breast milk.
Danish: Humane data viser, at tacrolimus udskilles i modermælk.
English: The 1-year patient survival rate was 80.8% in the tacrolimus and 83% in the ciclosporin group.
Danish: Overlevelsesraten efter 1-år for patienter var 80,8 % i tacrolimusgruppen og 83 % i ciclosporingruppen.
English: Increased tacrolimus doses, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes.
Danish: Øgede tacrolimusdoser, supplerende kortikosteroidbehandling og indsættelse af korte behandlingsperioder med mono-/polyklonale antistoffer er blevet benyttet til at behandle afstødningsepisoder.
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 orale dosis bør være 0,30 mg/kg/dag med start 8 - 12 timer efter afslutning af den intravenøse behandling.
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 transskriptionen af visse lymfokine gener forhindres.
English: The 1-year survival rates were 73.1% in the tacrolimus versus 79.2% in the ciclosporin group.
Danish: 1-års overlevelsesraterne lå på 73,1 % i tacrolimusgruppen versus 79,2 % i ciclosporingruppen.
English: very rare:
Danish: Meget sjælden:
English: Caution should be exercised in patients with risk factors for QT prolongation, including patients with a personal or family history of QT prolongation, congestive heart failure, bradyarrhythmias and electrolyte abnormalities.
Danish: Der skal udvises forsigtighed hos patienter med risikofaktorer for QTforlængelse, herunder patienter med en personlig eller familiær disposition for QT-forlængelse, kongestiv hjerteinsufficiens, bradyarytmi eller elektrolytforstyrrelser.
English: Enhanced nephrotoxicity has been observed following the administration of amphotericin B and ibuprofen in conjunction with tacrolimus.
Danish: Øget nefrotoksicitet er set ved administrering af amfotericin B eller ibuprofen sammen med tacrolimus.
English: (> 98.8%) to plasma proteins, mainly to serum albumin and α-1-acid glycoprotein.
Danish: I plasma er tacrolimus stærkt bundet (>98,8 %) til plasmaproteiner, hovedsagelig til serumalbumin og surt alfa-1glykoprotein.
English: Grapefruit and grapefruit juice should be avoided while taking Modigraf, since it can affect its levels in the blood.
Danish: Undgå grapefrugt og grapefrugt juice under behandling med Modigraf, da det kan påvirke indholdet af Modigraf i blodet.
English: This can lead to graft rejection or increased incidence of undesirable effects, including under- or overimmunosuppression, due to clinically relevant differences in systemic exposure to tacrolimus.
Danish: Dette kan føre til transplantatafstødning eller øget forekomst af bivirkninger, herunder under- og overimmunsuppression på grund af klinisk relevante forskelle i systemisk eksponering for tacrolimus.
English: As tacrolimus may reduce the clearance of steroid-based contraceptives leading to increased hormone exposure, particular care should be exercised when deciding upon contraceptive measures.
Danish: Da tacrolimus kan reducere clearance af steroidbaserede kontraceptive piller med øget hormoneksponering til følge, skal valg af prævention ske med omtanke.
English: Therefore, you should not breast-feed whilst using Modigraf.
Danish: Derfor må De ikke amme, mens De tager Modigraf.
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 blodkoncentrationen af tacrolimus kan ændres signifikant efter diarré, anbefales det at overvåge tacrolimuskoncentrationerne ekstra nøje i forbindelse med diarré.
English: Modigraf should be prescribed by doctors trained to treat transplant patients and experienced in the use of medicines that control the body's immune system (immunosuppressants).
Danish: Modigraf bør udskrives af læger, som er specielt oplært til at behandle transplantationspatienter, og som har erfaring med brug af lægemidler, som dæmper kroppens immunsystem (immunsuppressiva).
English: In healthy subjects, the average total body clearance estimated from whole blood concentrations was 2.25 l/h.
Danish: Hos raske forsøgspersoner var den gennemsnitlige totale kropsclearance beregnet ud fra koncentrationer i fuldblod 2,25 l/time.
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 patienter har man set værdier på henholdsvis 4,1 l/time, 6,7 l/time og 3,9 l/time.
English: Stable allograft recipients maintained on Modigraf granules, requiring conversion to Prograf capsules, should be converted on a 1:1 mg:mg total daily dose basis.
Danish: Stabile transplanterede patienter på vedligeholdelsesdosis med Modigrafgranulat som skal konverteres til Prografkapsler, bør konverteres på en 1:1 mg:mg total daglig basisdosis.
English: Immunosuppressants may affect the response to vaccination and vaccination during treatment with tacrolimus may be less effective.
Danish: Immunsuppressiva kan påvirke responset på vaccinationer, der under behandling med tacrolimus kan være mindre effektive.
English: Example: Total daily dose Prograf capsules given as 1 mg in the morning and 0.5 mg in the evening.
Danish: Eksempel: Total daglig dosis for Prografkapsler givet som 1 mg om morgenen og 0,5 mg om aftenen.
English: Posterior reversible encephalopathy syndrome (PRES) Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Danish: Det er rapporteret, at patienter, der får behandling med tacrolimus, udvikler posterior reversibel encefalopatisyndrom (PRES).
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) i forhold til (1,09 episoder) i ciclosporingruppen.
English: Within each frequency groupingadverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Medication errors, including inadvertent, unintentional or unsupervised substitution of immediate- or prolonged-release tacrolimus formulations, have been observed.
Danish: Medicineringsfejl, herunder utilsigtet, uforsætlig eller uovervåget substitution af umiddelbart udløste- eller depotformuleringer af tacrolimus, er set.
English: Then give a total daily dose of Modigraf 1.4 mg divided as 0.8 mg in the morning and 0.6 mg in the evening.
Danish: Giv da en total daglig dosis Modigraf på 1,4 mg opdelt som 0,8 mg om morgenen og 0,6 mg om aftenen.
English: Initial doses just after transplantation will generally be in the range of 0.075 - 0.30 mg per kg body weight per day depending on the transplanted organ.
Danish: Startdosis lige efter transplantationen vil sædvanligvis ligge i intervallet 0,075 - 0,30 mg/kg legemsvægt/døgn, afhængigt af, hvilket organ der er transplanteret.
English: If you forget to take Modigraf
Danish: Hvis De har glemt at tage Modigraf
English: In general, inadvertent, unintentional or unsupervised switching of immediate- or prolonged-release formulations of tacrolimus is unsafe.
Danish: Generelt er utilsigtet, uforsætlig eller uovervåget substitution af umiddelbart udløste- eller depotformuleringer af tacrolimus farligt.
English: The suspension can be drawn up with a syringe or swallowed directly by the patient.
Danish: Suspensionen kan suges op med en sprøjte eller patienten kan drikke det direkte.
English: The rate and extent of absorption of tacrolimus is greatest under fasted conditions.
Danish: Både mængden af og hastigheden hvormed tacrolimus absorberes er størst i fastende tilstand.
English: Dose adjustment during post-transplant period in adults and paediatric patients Tacrolimus doses are usually reduced in the post-transplant period.
Danish: Dosisjusteringer hos voksne og pædiatriske patienter i perioden efter transplantationen Tacrolimusdosis reduceres sædvanligvis i perioden efter transplantationen.
English: Modigraf passes into breast milk.
Danish: Modigraf passerer over i mælken.
English: In healthy subjects, the mean half-life in whole blood was approximately 43 hours.
Danish: Hos raske forsøgspersoner var middelværdien for halveringstiden i fuldblod ca. 43 timer.
English: When tacrolimus is administered intravenously as rapid infusion/bolus injection at a dose of 0.1 to 1.0 mg/kg, QTc prolongation has been observed in some animal species.
Danish: Når tacrolimus administreres intravenøst som hurtig infusion/bolusinjektion ved en dosis på 0,1 til 1,0 mg/kg er der hos nogle dyrearter observeret QTc -forlængelse.
English: Results of a single dose bioequivalence study with adult healthy volunteers showed that Modigraf granules were approximately 20% more bioavailable than the Prograf capsules.
Danish: Resultater af enkeltdosisbioækvivalensstudier hos voksne raske personer viste at Modigrafgranulat gennemsnitligt var 20 % mere biotilgængeligt end Prografkapsler.
English: The most commonly reported adverse reactions (occurring in > 10% of patients) are tremor, renal impairment, hyperglycaemic conditions, diabetes mellitus, hyperkalaemia, infections, hypertension and insomnia.
Danish: De hyppigst rapporterede bivirkninger (forekommer hos > 10 % af patienterne) er tremor, nyreinsufficiens, hyperglykæmi, diabetes mellitus, hyperkaliæmi, infektioner, hypertension og insomnia.
English: Patients treated with immunosuppressants, including Modigraf, are at increased risk for infections including opportunistic infections (bacterial, fungal, viral and protozoal) such as BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML).
Danish: Patienter behandlet med immunsuppressiva, herunder Modigraf, har en øget risiko for infektioner, herunder opportunistiske infektioner (bakteriel, fungal, viral og protozoal) såsom BK-virus associeret nefropati og JCvirus associeret progressiv multifokal leukoencefalopati (PML).
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: En multicenterundersøgelse hvori der indgik 205 patienter, der gennemgik simultan pancreasnyretransplantation blev randomiseret til tacrolimus- (n=103) eller ciclosporinbehandling (n=102).
English: Tacrolimus has been used with or without antibody induction in paediatric heart transplantation.
Danish: Tacrolimus er benyttet med og uden antistofinduktion til hjertetransplanterede børn.
English: In an additional 2-centre study, 26 patients were randomised to the tacrolimus versus 24 patients to the ciclosporin group.
Danish: I yderligere en undersøgelse i 2 centre blev 26 patienter randomiseret til tacrolimus versus 24 patienter til ciclosporin.
English: Cases of pure red cell aplasia (a very severe reduction in red blood cell counts), agranulocytosis (a severely lowered number of white blood cells), haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown) and febrile neutropenia (a decrease in the type of white blood cells which fight infection, accompanied by fever) have been reported.
Danish: Tilfælde af pure red cell aplasia (udtalt mangel på røde blodlegemer), agranulocytose (alvorligt nedsat antal hvide blodlegemer), hæmolytisk anæmi (nedsat antal røde blodlegemer på grund af unormal nedbrydning) og febril neutropeni (et fald i typen af hvide blodlegemer der bekæmper infektion, ledsaget af feber) er blevet indberettet.
English: Modigraf sachets must not be used partially.
Danish: Modigrafbreve må ikke deles.
English: Tacrolimus therapy is generally initiated by the oral route.
Danish: Tacrolimusterapi påbegyndes som regel oralt.
English: Significantly more ciclosporin-treated patients (n = 13) required a switch to tacrolimus than tacrolimus-treated patients to ciclosporin (n = 2) (p = 0.02).
Danish: Der var signifikant flere patienter i ciclosporingruppen (n=13), som måtte overføres til tacrolimus end tacrolimusbehandlede patienter, der måtte overføres til ciclosporin (n=2) (p=0,02).
English: The half-life of ciclosporin is prolonged when tacrolimus is given concomitantly.
Danish: Ciclosporinets halveringstid er forlænget ved samtidig administration af tacrolimus.
English: A negative effect of tacrolimus on male fertility in the form of reduced sperm counts and motility was observed in rats (see section 5.3).
Danish: En negativ effekt af tacrolimus på den mandlige fertilitet i form af reduceret spermantal og motilitet blev observeret hos rotter (se pkt.
English: If you stop taking Modigraf
Danish: Hvis De holder op med at tage Modigraf
English: Freedom from acute rejection was higher in the tacrolimus group at 6 months (57.7% versus 45.8%) and at 1 year after lung transplantation (50% versus 33.3%).
Danish: Fraværet af akut afstødning var højere i tacrolimusgruppen ved 6 måneder (57,7 % versus 45,8 %) og 1 år efter lungetransplantationen (50 % versus 33,3 %).
English: A combination of immunosuppressives such as antilymphocytic antibodies (e.g. basiliximab, daclizumab) given concomitantly increases the risk of EBV-associated lymphoproliferative disorders.
Danish: En kombination af immunsuppressiva - såsom antilymfocytiske antistoffer (f.eks. basiliximab, daclizumab) administreret samtidig - øger risikoen for EBVassocierede, lympfoproliferative sygdomme.
English: Tacrolimus blood trough levels should be determined approximately 12 hours post-dosing of Modigraf granules, just prior to the next dose.
Danish: Dalværdierne for tacrolimuskoncentrationer i blod bør måles i den post-operative fase og bør bestemmes ca. 12 timer efter dosering med Modigrafgranulat, umiddelbart før næste dosering.
English: Administration should commence within 24 hours after the completion of surgery.
Danish: Administrationen bør indledes inden for 24 timer efter afslutningen af indgrebet.
English: EXP: After preparation, the suspension should be administered immediately.
Danish: EXP: Suspensionen bør administreres umiddelbart efter fremstillingen.
English: High dose prednisolone or methylprednisolone administered for the treatment of acute rejection have the potential to increase or decrease tacrolimus blood levels.
Danish: Høj dosis af prednisolon eller metylprednisolon administreret til behandling af akut afstødning kan nedsætte eller øge tacrolimusblodkoncentrationerne.
English: As with other immunosuppressive agents, owing to the potential risk of malignant skin changes, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Danish: Da behandling med immunsuppressive midler øger risikoen for maligne hudlidelser, bør eksponering for sollys eller UV-lys begrænses ved at benytte passende beskyttende beklædning og ved brug af solbeskyttende cremer med høj faktorværdi.
English: You should generally take Modigraf on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal.
Danish: De bør kun tage Modigraf på tom mave eller mindst 1 time før eller 2 til 3 timer efter et måltid.
English: If abnormalities develop, dose reduction of Modigraf, or change of treatment to another immunosuppressive agent should be considered.
Danish: Ved tegn på anomalier bør man overveje at reducere doseringen af Modigraf eller skifte til en anden immunsuppressiv behandling.
English: Modigraf 1 mg granules for oral suspension EU/1/09/523/002
Danish: Modigraf 1 mg granulat til oral suspension EU/1/09/523/002
English: Benign and malignant tumours have been reported following Modigraf treatment.
Danish: Der er set godartede og ondartede svulster efter Modigrafbehandling.
English: Do not stop your treatment unless your doctor tells you to do so.
Danish: De må ikke stoppe med behandlingen, uden at have talt med Deres læge.
English: echocardiogram abnormal, electrocardiogram QT prolonged Injury, poisoning and procedural complications common:
Danish: unormalt ekkokardiogram, EKG med QT-forlængelse Traumer, forgiftning og behandlingskomplikationer Almindelig:
English: Modigraf granules are an immediate-release formulation of tacrolimus for twice daily dosing.
Danish: Modigrafgranulat er en lægemiddelform med umiddelbar frigivelse af tacrolimus, som tages to gange dagligt.
English: Pancreas survival at 1 year was significantly superior with tacrolimus: 91.3% versus 74.5% with ciclosporin (p < 0.0005), whereas renal graft survival was similar in both groups.
Danish: Overlevelse ved pancreastransplantater var efter 1 år signifikant bedre med tacrolimus end med ciclosporin: 91,3 % versus 74,5 % (p< 0,0005), mens overlevelsen ved nyretransplantater var den samme i de 2 grupper.
English: Tell your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation and pain), amphotericin B (used to treat bacterial infections) or antivirals (used to treat viral infections e.g. aciclovir).
Danish: Fortæl det til Deres læge, hvis De tager eller har brug for at tage ibuprofen (behandling af feber, betændelseslignende tilstande (gigt) og smerter), amphotericin B (behandling af bakterie-infektioner) eller antivirale midler (behandling af virusinfektioner, f.eks. aciclovir).
English: Do not use any utensils or liquids to empty the sachet.
Danish: Brug ikke redskaber eller væske til at tømme brevet med.
English: In stable liver transplant patients, the oral bioavailability of tacrolimus was reduced when it was administered after a meal of moderate fat (34% of calories) content.
Danish: Hos stabile levertransplanterede patienter reduceres den orale biotilgængelighed, når Prograf administreres efter et måltid med moderat fedtindhold (34 % af kalorierne).
English: Patients treated with tacrolimus have been reported to develop Epstein-Barr Virus (EBV)-associated lymphoproliferative disorders (see section 4.8).
Danish: Hos patienter, der er blevet behandlet med tacrolimus, er der observeret udvikling af Epstein-BarrVirus (EBV)-associerede lymfoproliferative tilstande (se pkt.
English: Modigraf dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below under “Therapeutic drug monitoring”).
Danish: Doseringen af Modigraf bør primært baseres på en klinisk bedømmelse af afstødning og tolerans for hver enkelt patient vejledt af overvågninger af blodkoncentrationer (se nedenfor under ”Terapeutisk lægemiddelovervågning”).
English: Grapefruit juice has been reported to increase the blood level of tacrolimus and should therefore be avoided.
Danish: Det er rapporteret, at grapejuice øger koncentrationen af tacrolimus, hvorfor det bør undgås.
English: If equal doses are not possible, the total daily dose of Prograf should be rounded-up to the nearest amount possible, with the higher dose given in the morning and the lower dose in the evening.
Danish: Hvis samme dosis ikke er mulig, bør dosis for Prograf rundes op til den nærmeste mulige mængde, hvor den høje dosis gives om morgenen og den lave dosis om aftenen.
English: Modigraf contains lactose and sodium
Danish: Modigraf indeholder lactose og natrium