FrancophonIA/ELRC3.0 huggingface dataset:
English: That contention is also supported by a greater number of patients who need rescue therapy switching from ciclosporin to tacrolimus than the other way around.
Danish: Denne opfattelse støttes af, at der er flere patienter, hvis livsreddende behandling må ændres fra cyklosporin til tacrolimus, end omvendt.
English: Human data demonstrate that tacrolimus is excreted into breast milk.
Danish: Humane data viser at tacrolimus udskilles i modermælk.
English: Tacrolimus has established itself as an alternative to cyclosporine in cardiac transplant immunosuppression.
Danish: Tacrolimus er et almindeligt anerkendt alternativ til cyklosporin til immunosuppression ved hjertetransplantation.
English: Dosing should be delayed in the presence of elevated ciclosporin blood levels.
Danish: Dosering bør udsættes i tilfælde af forhøjede ciclosporin blodkoncentrationer.
English: Experience with overdosage is limited.
Danish: Erfaringerne er begrænsede.
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%) (Treede et al., J Heart Lung Transplant 2001;20:511).
Danish: Fravær af akut afstødning var højere i tacrolimusgruppen ved 6 måneder (57,7% versus 45,8%) og 1 år efter lungetransplantationen (50% versus 33,3%) (Treede et al., J Heart Lung Transplant 2001;20:511).
English: In rats, female reproductive function including birth was impaired at toxic dosages and the offspring showed reduced birth weights, viability and growth.
Danish: Hos hunrotter blev den reproduktive funktion inklusiv fødsel nedsat ved toksiske doser og der sås lavere fødselsvægt, levedygtighed og vækst hos afkommet.
English: Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Danish: Patienter i immunosuppressiv behandling har en øget risiko for at få maligne lidelser.
English: In adult and paediatric liver transplant patients, it averaged 11.7 hours and 12.4 hours, respectively, compared with 15.6 hours in adult kidney transplant recipients.
Danish: Hos levertransplanterede voksne og børn var værdien henholdsvis 11,7 timer og 12,4 timer og hos voksne nyretransplanterede fandt man en værdi på 15,6 timer.
English: If clinical signs of rejection are apparent, alteration of the immunosuppressive regimen should be considered.
Danish: I tilfælde af tydelige kliniske tegn på afstødning, bør ændring af det immunosuppressive regime overvejes.
English: No specific antidote to <Invented name> therapy is available.
Danish: Der findes ingen specifik antidot til <[(Sær)navn]>behandling.
English: Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products.
Danish: Behandling af allotransplantat afstødning, der er resistent for behandling med andre immunosupressive lægemidler.
English: For conversion to <Invented name>, treatment should begin with the initial oral dose recommended for primary immunosuppression.
Danish: Ved konvertering til <[(Sær)navn]> bør behandlingen starte med den anbefalede initiale perorale dosis for primær immunosuppression.
English: In an additional two-centre study, 26 patients were randomised to the tacrolimus versus 24 patients to the ciclosporin group.
Danish: I yderligere et 2-center studie, blev 26 patienter randomiseret til tacrolimus versus 24 patienter til ciclosporin.
English: Another randomised study included 66 patients on tacrolimus versus 67 patients on ciclosporin.
Danish: Et andet randomiseret studie omfattede 66 patienter på tacrolimus og 67 patienter på ciclosporin.
English: Factors such as low haematocrit and protein levels, which result in an increase in the unbound fraction of tacrolimus, or corticosteroid-induced increased metabolism are considered to be responsible for the higher clearance rates observed following transplantation.
Danish: Faktorer som lav hæmatokrit og lavt serumprotein, der giver en øget ubunden fraktion af tacrolimus, samt kortikoidinduceret øget metabolisme, betragtes som hovedårsagerne til den højere clearance, man finder hos transplanterede.
English: Comparisons of concentrations from the published literature to individual values in clinical practice should be assessed with care and knowledge of the assay methods employed.
Danish: Man skal være varsom med at sammenligne koncentrationer nævnt i publicerede undersøgelser med individuelle værdier i klinikken, uden at vide hvilket assay og hvilken metode, der blev benyttet.
English: dermatitis, photosensitivity rare:
Danish: dermatitis, photosensibilisering
English: The risk of anaphylaxis may be reduced by slow infusion of reconstituted <Invented name> 5 mg/ml Concentrate for Solution for Infusion or by the prior administration of an antihistamine.
Danish: Risikoen for anafylaktiske reaktioner kan reduceres ved langsom infusion af <[(Sær)navn]> 5 mg/ml koncentrat till infusionsvæske, opløsning eller ved forudgående administrering af antihistamin.
English: Tacrolimus has been shown to increase the blood level of phenytoin.
Danish: Tacrolimus øger blodkoncentrationen af phenytoin.
English: This has been done mainly by long time experience with the drug at different centres in Europe and the US. Data from “The Registry of the International Society for Heart and Lung Transplantation” (ISHLT) confirm the findings of the MAH's pivotal study in primary heart transplantation as well as the results of an array of small, single centre, open, randomized/nonrandomized studies.
Danish: Oplysninger fra "The Registry of the International Society for Heart and Lung Transplantation" (ISHLT) bekræfter resultaterne af registreringsindehaverens hovedforsøg med primær hjertetransplantation såvel som resultaterne af en række små, åbne, randomiserede/ikke randomiserede enkeltcenterforsøg.
English: <Invented name> must not be taken with ciclosporin.
Danish: <[(Sær)navn]> må ikke tages sammen med ciclosporin.
English: <Invented name> must not be used with ciclosporin.
Danish: <[(Sær)navn]> må ikke anvendes sammen med ciclosporin.
English: These dose recommendations for lung, pancreas and intestinal transplantation are based on limited prospective clinical trial data.
Danish: Denne doseringsvejledning for lunge-, pancreas- og tarmtransplantation er baseret på begrænsede, prospektive kliniske data.
English: This medicinal product is authorised in the Member States of the EEA under the following name:
Danish: Dette lægemiddel er godkendt i medlemsstaterne samt Norge og Island under følgende navne: Prograf:
English: Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with <Invented name>.
Danish: Man skal derfor kende EBV-VCA-serologien hos disse, før man starter behandlingen.
English: dermatitis, burning sensation in the sunlight rare:
Danish: eksem, brændende fornemmelse i sollys
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Oral anvendelse.
English: Initial doses just after transplantation will generally be in the range of
Danish: Doseringen lige efter en transplantation er sædvanligvis
English: primary graft dysfunction
Danish: funktionssvigt af primær graft
English: <Invented name> is used to control your body's immune response enabling your body to accept the transplanted organ.
Danish: <[(Sær)navn]> benyttes til at kontrollere din krops immunreaktion, således at kroppen kan acceptere det nye organ.
English: Clinically significant interactions have also been observed with phenobarbital.
Danish: Der er også rapporteret klinisk relevante interaktioner med phonobarbital.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Intravenøs anvendelse.
English: Protein binding considerations
Danish: Proteinbinding
English: <Invented name> reduces your body's own defense mechanism to stop you rejecting your transplanted organ.
Danish: <[(Sær)navn]> nedsætter kroppens egen forsvarsmekanisme for at undgå afstødning af det transplanterede organ.
English: <Invented name> dosing should primarily be based on clinical assessments of rejection and tolerability in each patient individually aided by blood level monitoring (see below for recommended target whole blood trough concentrations).
Danish: <[(Sær)navn]> dosis skal primært baseres på klinisk bedømmelse af afstødning og tolerabilitet for hver enkelt patient vejledt af målinger af blodkoncentration (de anbefalede mål for fuldblods dalkoncentrationer er angivet nedenfor).
English: As <Invented name> is a medicinal product with low clearance, adjustments to the dosage regimen may take several days before changes in blood levels are apparent.
Danish: Da <[(Sær)navn]> er et lægemiddel med lav clearance kan det tage adskillige dage før en dosisændring afspejles i ændret blodkoncentration.
English: Important information about some of the ingredients of <Invented name> - <Invented name> contains polyoxyethylene hydrogenated castor oil that may, in a small number of patients, lead to a severe allergic reaction.
Danish: Vigtige oplysninger om visse af indholdsstofferne i <[(Sær)navn]> - <[(Sær)navn]> indeholder polyoxyethylenhydrogeniseret ricinisoliesom hos en lille antal patienter kan forårsage en alvorlig allergisk reaktion.
English: The half-life of tacrolimus is long and variable.
Danish: Halveringstiden for tacrolimus er lang og varierer fra gruppe til gruppe.
English: very rare:
Danish: Meget sjældne:
English: 0.075 - 0.30 mg per kg body weight per day depending on the transplanted organ.
Danish: 0,075-0,30 mg/kg legemsvægt per døgn afhængigt af hvilket organ der er transplanteret.
English: - If you are allergic (hypersensitive) to any of the other ingredients <To be implemented nationally - in particular polyoxyethylene hydrogenated castor oil or similar substances.>
Danish: - Hvis De er allergisk (overfølsom) overfor andre indholdstoffer især <Udfyldes nationalt polyoxyethylenhydrogeniseret ricinusolie eller lignende stoffer.>
English: Increased <Invented name> doses, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes.
Danish: Øgede <[(Sær)navn]> doser, supplerende kortikosteroidbehandling, indsættelse af korte behandlingsperioder med mono/polyklonale antistoffer er blevet benyttet til at behandle afstødningsepisoder.
English: Using other medicines
Danish: Anvendelse af anden medicin
English: Of note is the probable greater propensity of tacrolimus and ciclosporin to cause glucose intolerance and clinically manifest diabetes mellitus.
Danish: Det bør bemærkes, at tacrolimus og cyklosporin antageligt har større tilbøjelighed til at forårsage glucoseintolerance og klinisk påvist diabetes mellitus.
English: Do not stop your treatment unless your doctor tells you to do so.
Danish: De må ikke ophøre behandlingen uden at have talt med lægen.
English: If you take more <Invented name> than you should If you have accidentally taken too much <Invented name> see your doctor or contact your nearest hospital emergency department immediately.
Danish: Hvis De ved en fejltagelse har taget for mange <[(Sær)navn]> kapsler skal De straks kontakte lægen eller den nærmeste skadestue.
English: SPECIAL STORAGE CONDITIONS [To be completed nationally]
Danish: SÆRLIGE OPBEVARINGSBETINGELSER [Udfyldes nationalt]
English: Concomitant use of medicinal products or herbal remedies known to inhibit or induce CYP3A4 may affect the metabolism of tacrolimus and thereby increase or decrease tacrolimus blood levels.
Danish: Samtidig brug af lægemidler og naturmedicin, der vides at hæmme eller inducere CYP3A4, kan påvirke metabolismen af tacrolimus og derved nedsætte eller øge blodkoncentrationerne af tacrolimus.
English: Care should be taken when converting patients from ciclosporin-based to <Invented name>-based therapy (see sections 4.4 and 4.5).
Danish: Der bør udvises forsigtighed, når patienter skifter fra behandling med ciclosporin til <[(Sær)navn]>baseret behandling se afsnit 4.4 og 4.5.
English: 0.01 - 0.10 mg per kg body weight per day depending on the transplanted organ.
Danish: 0,01-0,10 mg/kg legemsvægt per døgn afhængigt af hvilket organ der er transplanteret.
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: Pancreas overlevelse var efter 1 år signifikant bedre med tacrolimus end med ciclosporin : 91,3% versus 74,5% (p< 0,0005) medens overlevelsen af nyretransplantater var ens i de 2 grupper.
English: If clinically relevant changes are seen, adjustments of the immunosuppressive regimen should be considered.
Danish: Forekommer der klinisk relevante ændringer, skal justering af den immunosuppressive behandling overvejes.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, ANSØGER(E), INDEHAVERE AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE OG NORGE OG ISLAND
English: Dosage recommendations are provided for rejection therapy, concerning “other allografts”.
Danish: Der gives doseringsvejledning for behandling af afstødning af "andre allotransplantater".
English: Stopping your treatment with <Invented name> may increase the risk of rejection of your transplanted organ.
Danish: Afbrydelse af behandlingen med <[(Sær)navn]> kan øge risikoen for afstødning af det transplanterede organ.
English: Tatoiou Street Lamia NationalRoad 14671 Nea Erythrea Greece
Danish: Lamia National Road 14671 Nea Erythrea Grækenland
English: Clinically the following substances have been shown to decrease tacrolimus blood levels: Strong interactions have been observed with rifampicin, phenytoin or St. John's Wort (Hypericum perforatum) which may require increased tacrolimus doses in almost all patients.
Danish: Følgende midler er vist klinisk at nedsætte tacrolimus blodkoncentration: Kraftige interaktioner er rapporteret med rifampicin, phenytoin og prikbladet hyperikum, som kan kræve øget dosering af tacrolimus til næsten alle patienter.
English: It is therefore recommended to monitor tacrolimus blood levels whenever substances which have the potential to alter CYP3A metabolism are used concomitantly and to adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure (see sections 4.2 and 4.4).
Danish: Det anbefales derfor at måle tacrolimus blodkoncentrationer, når lægemidler som kan ændre CYP3A4 metabolismen benyttes samtidigt og at justere tacrolimus doseringen tilsvarende, for at vedligeholde konstant eksponering for tacrolimus (se afsnit 4.2 og 4.4).
English: FURTHER INFORMATION What <Invented name> contains - The active substance is tacrolimus - The other ingredients are [To be completed nationally].
Danish: YDERLIGERE OPLYSNINGER Hvad <[(Sær)navn]> indeholder - Det aktive stof er tacrolimus.
English: There is consistent evidence across many small and some moderate sized clinical trials that tacrolimus is an effective maintenance immunosuppressant when used as part of a multi-agent regimen.
Danish: Resultaterne af mange små og en del lidt større kliniske forsøg viser samstemmende, at tacrolimus er effektivt til immunosuppressiv vedligeholdelsesbehandling, anvendt i kombinationsbehandling.
English: Monitoring of ciclosporin blood levels should be continued following conversion as the clearance of ciclosporin might be affected.
Danish: Målinger af ciclosporin blodkoncentrationer bør fortsætte efter skift til <[(Sær)navn]>, da ciclosporinets clearance kan være påvirket.
English: Effect of tacrolimus on the metabolism of other medicinal products Tacrolimus is a known CYP3A4 inhibitor; thus concomitant use of tacrolimus with medicinal products known to be metabolised by CYP3A4 may affect the metabolism of such medicinal products.
Danish: Effekt af tacrolimus på andre lægemidlers metabolisme Da tacrolimus er en kendt CYP3A4 inhibitor vil samtidig brug af tacrolimus påvirke metabolismen af lægemidler, der metaboliseres via CYP3A4.
English: High dose prednisolone or methylprednisolone administered for the treatment of acute rejection have the potential to increase or decrease tacrolimus blood levels.
Danish: Høje doser prednisolon eller metylprednisolon givet ved behandling af akut afstødning er i stand til at nedsætte eller øge tacrolimus blodkoncentrationer.
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 immunosuppressive 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: - If you need to have any vaccinations, please inform your doctor beforehand.
Danish: - Hvis De planlægger at blive vaccineret, skal De oplyse lægen herom.
English: Most cases have been reversible, occurring primarily in children with tacrolimus blood trough concentrations much higher than the recommended maximum levels.
Danish: De fleste tilfælde har været reversible og er primært set hos børn, der har haft langt højere bloddalkoncentrationer af <[(Sær)navn]> end den anbefalede maksimale koncentration.
English: GROUNDS FOR AMENDMENT OF THE SUMMARY(IES) OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR ÆNDRINGEN AF PRODUKTRESUMÉET, ETIKETTERINGEN OG INDLÆGSSEDLEN
English: hearing impaired
Danish: nedsat hørelse
English: In vitro the following substances have been shown to be potential inhibitors of tacrolimus metabolism: bromocriptine, cortisone, dapsone, ergotamine, gestodene, lidocaine, mephenytoin, miconazole, midazolam, nilvadipine, norethindrone, quinidine, tamoxifen, (triacetyl)oleandomycin.
Danish: Følgende midler er vist at være potentielle hæmmere på tacrolimus metabolisme in vitro: Bromocriptin, kortison, dapson, ergotamin, gestoden, lidocain, mephenytoin, miconazol, midazolam, nilvadipin, norethindron, quinidin, tamoxifen, (triacetyl)oleandomycin.
English: bleeding, partial or complete blocking of blood vessels, reduced blood pressure uncommon:
Danish: blødning, delvis eller fuldstændig blokering af blodkar, nedsat blodtryk
English: Tacrolimus affected male fertility in rats (see section 5.3).
Danish: Tacrolimus påvirker fertiliteten hos hanrotter (se afsnit 5.3).
English: Systemically available tacrolimus is metabolised by hepatic CYP3A4.
Danish: Systemisk tilgængeligt tacrolimus metaboliseres via CYP3A4.
English: Clinically the following substances have been shown to increase tacrolimus blood levels: Strong interactions have been observed with antifungal agents such as ketoconazole, fluconazole, itraconazole and voriconazole, the macrolide antibiotic erythromycin or HIV protease inhibitors (e.g. ritonavir).
Danish: Følgende midler er vist at øge tacrolomus blodkoncentration: Der er set kraftige interaktioner med svampemidler som ketoconazol, fluconazol, itraconazol og voriconazol, det macrolide antibiotikum erythromycin eller HIV protease inhibitorer (f.eks. ritronavir).
English: erythromycin, clarithromycin, josamycin, and rifampicin - HIV protease inhibitors e.g ritonavir - the anti-ulcer substance omeprazole - hormone treatments with ethinylestradiol (e.g the oral contraceptive pill) or danazol - medicines for high blood pressure or heart problems such as nifedipine, nicardipine, diltiazem and verapamil medicines known as “statins” used to treat elevated cholesterol and triglycerides - the anti-epileptic medicines phenytoin or phenobarbital - the corticosteroids prednisolone and methylprednisolone - the anti-depressant nefazodone - St. John's Wort (hypericum perforatum)
Danish: josamycin og rifampicin - HIV protease hæmmere f.eks. ritonavir - mavesårsmedicinen omeprasol - hormonbehandling med ethinylestradiol (f.eks. p-piller) eller danazol - medicin mod forhøjet blodtryk eller hjerteproblemer som nifedipin, nicardipin, diltiazem og verapamil - lægemidler kendt som ”statiner” til behandling af forhøjet kolesterol og triglycerider - epilepsimidlerne phenytoin og phenobarbital - kortikosteroiderne prednisolon og methylprednisolon - det antidepressive middel nefazodon - prikbladet perikum (hypericum perforatum)
English: Infections and infestations
Danish: Infektiøse og parasitære sygdomme
English: blindness
Danish: blindhed
English: Based on its high molecular weight, poor aqueous solubility, and extensive erythrocyte and plasma protein binding, it is anticipated that tacrolimus will not be dialysable.
Danish: Som følge af den høje molekylevægt, den ringe vandopløselighed og stærke binding til erythrocytter og plasmaprotein vil <[(Sær)navn]> ikke være dialysabelt.
English: Small numbers of children were included in various trials; however, there also exists one randomised controlled (vs. cyclosporine micro-emulsion and in combination with corticosteroids and azthioprine) 6-months paediatric study.
Danish: Foruden en række undersøgelser, som omfattede et lavt antal børn, foreligger der en randomiseret, kontrolleret 6-måneders pædiatrisk forsøg (med cyklosporin mikroemulsion som sammenligningspræparat og i kombination med kortikosteroider og azathioprin).
English: Benign and malignant tumours have been reported following <Invented name> treatment as a result of immunosuppression.
Danish: Der er set godartede og ondartede svulster efter <[(Sær)navn]> bebehandling som et resultat af immunosuppressionen.
English: Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, danazol, ethinylestradiol, omeprazole and nefazodone.
Danish: Svagere interaktioner er set med clotrimazol, clarithromycin, josamycin, nifedipin, nicardipin, diltiazem, verapamil, danazol, ethinylestradiol, omeprazol og nefazodon.
English: Astellas Pharma Ges.m.b.H.
Danish: Astellas Pharma Ges.m.b.H Linzerstr.
English: Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed on rare occasions.
Danish: Ventrikulær hypertrofi eller hypertrofi af septum er i enkelte tilfælde blevet rapporteret som cardiomyopati i forbindelse med behandling med <[(Sær)navn]>.
English: Do not take <Invented name> - If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of <Invented name>.
Danish: De bør ikke tage <[(Sær)navn]>: - Hvis De er allergisk (overfølsom )overfor tacrolimus eller et af de øvrige indholdsstoffer i
English: Hypersensitivity to any of the excipients <To be implemented nationally - in particular polyoxyethylene hydrogenated castor oil or structurally related compounds.>
Danish: Kendt overfølsomhed overfor andre indholdstoffer <Udfyldes nationalt - især polyoxyethylenhydrogeniseret ricinusolie eller strukturrelaterede stoffer.>
English: Pancreas transplantation
Danish: Pancreastransplantation
English: anaemia, leukopenia, thrombocytopenia, leukocytosis, red blood cell analyses abnormal uncommon:
Danish: anæmi, leukopeni, thrombocytopeni, leukocytose, unormale røde blodcelle analyser
English: Prophylaxis of transplant rejection in liver, kidney or heart allograft recipients.
Danish: Profylakse af transplantatafstødning til nyre, lever og hjerte allotransplantat recipienter.
English: For information on conversion from ciclosporin to <Invented name>, see below under “Dose adjustments in specific patient populations”.
Danish: Information om skift fra ciclosporin til <[(Sær)navn]> findes i "Dosisjustering i specielle patientgrupper".
English: In a study of stable renal transplant patients who were administered <Invented name> immediately after a standard continental breakfast the effect on oral bioavailability was less pronounced.
Danish: I en undersøgelse med stabile nyretransplanterede patienter er virkningen på peroral biotilgængelighed mindre udtalt ved indgift af <[(Sær)navn]> umiddelbart efter en normal kontinental morgenmad.