FrancophonIA/ELRC3.0 huggingface dataset:
English: An updated RMP should be submitted: - At the request of the European Medicines Agency, - Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Maintenance doses of corticosteroids have been shown to reduce tacrolimus blood levels.
Danish: Vedligeholdelsesdoser af kortikosteroider reducerer tacrolimus' blodkoncentration.
English: Hypromellose Ethylcellulose Lactose monohydrate Magnesium stearate.
Danish: Hypromellose Ethylcellulose Lactosemonohydrat Magnesiumstearat.
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Advagraf.
Danish: Tilfælde af BK-virus associeret nefropati og JC-virus associeret progressiv multifokal leukoencephalopati (PML) er rapporteret hos patienter, der har fået behandling med immunsuppressorer, herunder Advagraf.
English: The efficacy and safety of Advagraf and Prograf, both in combination with corticosteroids, was compared in 471 de novo liver transplant recipients.
Danish: Virkningen og sikkerheden af Advagraf og Prograf, begge i kombination med kortikosteroider, blev sammenlignet i 471 de novo levertransplanterede patienter.
English: A lower incidence of acute rejection episodes for tacrolimus- versus ciclosporin-treated patients (11.5% versus 22.6%) and a lower incidence of chronic rejection, the bronchiolitis obliterans syndrome (2.86% versus 8.57%), was reported within the first year after transplantation.
Danish: Det første år efter transplantationen blev der rapporteret en lavere incidens af akutte afstødningsepisoder for tacrolimus- versus ciclosporinbehandlede patienter (11,5 % versus 22,6 %) og en lavere incidens af kronisk afstødning, bronchiolitis obliterans syndromet (2,86 % versus 8,57 %).
English: Other interactions leading to clinically detrimental effects Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects (e.g., aminoglycosides, gyrase inhibitors, vancomycin, cotrimoxazole, NSAIDs, ganciclovir or aciclovir).
Danish: Andre interaktioner som har klinisk skadelig effekt Samtidig brug af tacrolimus og lægemidler med kendt nefrotoksisk eller neurotoksisk effekt kan øge toksiciteten (f.eks. aminoglycosider, gyrase-hæmmere, vancomysin, cotrimoxazol, NSAID, gangliclovir og aciclovir).
English: Each capsule contains less than 1 mmol sodium (23 mg).
Danish: Hver kapsel indeholder mindre end 1 mmol (23 mg) natrium.
English: - if you are allergic to sirolimus or to any macrolide-antibiotic (e.g. erythromycin, clarithromycin, josamycin).
Danish: - hvis De er allergisk over for sirolimus eller over for makrolidantibiotika (f.eks. erythomycin,
English: Concomitant use of substances known to inhibit or induce CYP3A4 may affect the metabolism of tacrolimus and thereby increase or decrease tacrolimus blood levels.
Danish: Samtidig brug af stoffer, der vides at hæmme eller inducere CYP3A4, kan påvirke tacrolimus' metabolisme og derved nedsætte eller øge tacrolimusblodkoncentrationerne.
English: Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.2 and 4.8).
Danish: Patienter bør fastholdes på én lægemiddelform af tacrolimus med det tilsvarende daglige dosisregime; ændringer i lægemiddelform eller regime bør kun ske under nøje supervision fra en transplantationsspecialist (se pkt.
English: Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, amiodarone, danazol, ethinylestradiol, omeprazole, nefazodone and (Chinese) herbal remedies containing extracts of Schisandra sphenanthera.
Danish: Svagere interaktioner er set med clotrimazol, clarithromycin, josamycin, nifedipin, nicardipin, diltiazem, verapamil, amiodaron, danazol, ethinylestradiol, omeprazol, nefazodon og (kinesisk) naturmedicin indeholdende ekstrakt af Schisandra sphenanthera.
English: Capsule content: Hypromellose, ethylcellulose, lactose, magnesium stearate.
Danish: Kapselindhold: Hypromellose, ethylcellulose, lactosemonohydrat, magnesiumstearat.
English: 12-month graft survival was 96.7% for Advagraf, 92.9% for Prograf and 95.7% for ciclosporin.
Danish: Transplantatoverlevelsen efter 12 måneder var 96,7 % for Advagraf, 92,9 % for Prograf og 95,7 % for ciclosporin.
English: The relationship between tacrolimus trough levels (C24) and systemic exposure (AUC0-24) for Advagraf is similar to that of Prograf.
Danish: Forholdet mellem dalværdierne (C24) og systemisk eksponering (AUC0-24) af Advagraf er sammenligneligt med det for Prograf.
English: Caution should also be exercised in patients diagnosed or suspected to have Congenital Long QT Syndrome or acquired QT prolongation or patients on concomitant medications known to prolong the QT interval, induce electrolyte abnormalities or known to increase tacrolimus exposure (see section 4.5).
Danish: Forsigtighed bør også udvises hos patienter, som er diagnosticeret med eller mistænkes for at have medfødt lang QT-syndrom eller erhvervet QTforlængelse, eller patienter, som samtidig får behandling med lægemidler, som er kendt for at forlænge QT-intervallet, inducere elektrolytforstyrrelser eller øge tacrolimuseksponeringen (se pkt.
English: Several cases of accidental overdose have been reported with tacrolimus; symptoms have included tremor, headache, nausea and vomiting, infections, urticaria, lethargy and increases in blood urea nitrogen, serum creatinine and alanine aminotransferase levels.
Danish: Der er blevet rapporteret adskillige tilfælde af utilsigtet overdosering med tacrolimus som: Tremor, hovedpine, kvalme og opkastninger, infektioner, urticaria, letargi og forhøjet blodurinstof, serumkreatinin og alanin-aminotransferase.
English: Benign as well as malignant neoplasms including EBV-associated lymphoproliferative disorders and skin malignancies have been reported in association with tacrolimus treatment.
Danish: Benigne og maligne neoplasmatiske lidelser herunder EBV-associerede lymfoproliferative lidelser og maligne tilstande i huden er blevet rapporteret i forbindelse med behandling med tacrolimus.
English: During the initial post-transplant period, monitoring of the following parameters should be undertaken on a routine basis: blood pressure, ECG, neurological and visual status, fasting blood glucose levels, electrolytes (particularly potassium), liver and renal function tests, haematology parameters, coagulation values, and plasma protein determinations.
Danish: I den første postoperative periode kontrolleres regelmæssigt med måling af blodtryk, EKG, neurologisk status og synsstatus, fastende blodsukker, elektrolytter (specielt kalium), lever- og nyrefunktion, hæmatologiske parametre, koagulationsstatus og plasmaprotein.
English: The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor calculated according to your body weight.
Danish: Deres læge vil beregne den rigtige startdosis for at undgå afstødning af det transplanterede organ ud fra Deres vægt.
English: pure red cell aplasia, agranulocytosis, haemolytic anaemia Immune system disorders
Danish: pure red cell aplasia, agranulocytose, hæmolytisk anæmi
English: : +372 6 056 014 Fax: +372 6 056 011
Danish: Biocodex OÜ Tel. +372 6 056 014 Fax +372 6 056 011
English: This has led to serious adverse reactions, including graft rejection, or other adverse reactions which could be a consequence of either under- or over-exposure to tacrolimus.
Danish: Dette har ført til alvorlige bivirkninger herunder transplantatafstødning eller andre bivirkninger, som mulig konsekvens af enten over- eller undereksponering for tacrolimus.
English: Post-transplant changes in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.
Danish: Ændringer i patientens tilstand efter transplantation kan medføre ændret farmakokinetik for tacrolimus, hvilket kan nødvendiggøre yderligere dosisjusteringer.
English: Limited data from organ transplant recipients show no evidence of an increased risk of adverse reactions on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products.
Danish: Begrænsede data fra organtransplanterede recipienter, der sammenligner tacrolimus med andre immunsuppressive midler, viser ingen tegn på øget risiko for ugunstig indflydelse på graviditetsforløbet eller resultatet heraf ved behandling med tacrolimus.
English: For treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients clinical data are not yet available for the prolonged-release formulation Advagraf.
Danish: Til behandling af afstødning af allograf hos voksne patienter, som er resistente over for andre immunsuppressive medicinske produkter, er de kliniske data endnu ikke tilgængelige for Advagraf-depotformuleringen.
English: In clinical practice, whole blood trough levels have generally been in the range 5 - 20 ng/ml in liver transplant recipients and 10 - 20 ng/ml in kidney and heart transplant patients in the early post-transplant period.
Danish: I klinisk praksis har dalværdierne for koncentrationer i fuldblod generelt ligget fra 5 - 20 ng/ml for levertransplanterede og fra 10 - 20 ng/ml for nyre- og hjertetransplanterede i den tidlige postoperative periode.
English: As tacrolimus is a substance with low clearance, following adjustments to the Advagraf dose regimen it may take several days before the targeted steady state is achieved.
Danish: Da tacrolimus er et lægemiddelstof med lav clearance, kan det tage adskillige dage efter en dosisjustering af Advagraf, før den ønskede steady state er opnået.
English: The efficacy and safety of Prograf, ciclosporin and Advagraf, all in combination with basiliximab antibody induction, MMF and corticosteroids, was compared in 638 de novo kidney transplant recipients.
Danish: Virkningen og sikkerheden af Prograf, ciclosporin og Advagraf, alle i kombination med basiliximab antistofinduktion, MMF og kortikosteroider, blev sammenlignet i 638 de novo nyretransplanterede patienter.
English: In the systemic circulation, tacrolimus binds strongly to erythrocytes resulting in an approximate 20:1 distribution ratio of whole blood/plasma concentrations.
Danish: Tacrolimus er kraftigt bundet til erytrocytterne, således at fuldblod/plasmakvotienten er ca. 20:1.
English: Trembling, headache
Danish: hovedpine, tremor
English: Advagraf is a once-a-day oral formulation of tacrolimus.
Danish: Advagraf er en oral formulering af tacrolimus, som skal tages en gang daglig.
English: Herbal preparations containing St. John's Wort (Hypericum perforatum) or other herbal preparations should be avoided when taking Advagraf due to the risk of interactions that lead to either a decrease in blood concentrations of tacrolimus and reduced clinical effect of tacrolimus, or an increase in blood concentrations of tacrolimus and risk of tacrolimus toxicity (see section 4.5).
Danish: Naturlægemidler, der indeholder perikon (Hypericum perforatum), eller anden naturmedicin bør undgås ved behandling med Advagraf pga. risikoen for interaktioner, som kan medføre enten et fald i blodkoncentrationen af tacrolimus og reduceret terapeutisk effekt af tacrolimus eller en stigning i blodkoncentrationen af tacrolimus og risiko for tacrolimustoksicitet (se pkt.
English: problems with your vision such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
Danish: Fortæl straks Deres læge, hvis De under behandlingen lider af: problemer med Deres syn, såsom sløret syn, ændringer i farvesynet, problemer med at se detaljer eller hvis Deres synsfelt bliver begrænset.
English: It is strongly recommended to closely monitor tacrolimus blood levels, as well as, QT prolongation (with ECG), renal function and other side effects, whenever substances which have the potential to alter CYP3A4 metabolism or otherwise influence tacrolimus blood levels are used concomitantly, and to interrupt or adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure (see sections 4.2 and 4.4).
Danish: Det anbefales kraftigt at monitorere tacrolimus' blodkoncentration såvel som QT-forlængelse (med EKG), nyrefunktionen og andre bivirkninger ved samtidig brug af lægemidler, som kan ændre CYP3A4-metaboliseringen eller på anden vis påvirke tacrolimus' blodkoncentration, og at afbryde eller justere tacrolimusdosis tilsvarende for at vedligeholde en konstant eksponering (se pkt.
English: Printing ink: Shellac, lecithin (soya), simeticone, red iron oxide (E 172), hydroxypropylcellulose.
Danish: Printblæk: Shellac, lecithin (soja), simeticon, rød jernoxid (E172), hydroxypropylcellulose.
English: 12-month graft survival was 85.3% for Advagraf and 85.6% for Prograf.
Danish: Transplantatoverlevelsen efter 12 måneder var 85,3 % for Advagraf og 85,6 % for Prograf.
English: Post-transplant improvement in the condition of the patient may alter the pharmacokinetics of tacrolimus and may necessitate further dose adjustments.
Danish: Forbedring i patientens tilstand efter transplantation kan medføre ændret farmakokinetik for tacrolimus, hvilket kan nødvendiggøre yderligere dosisjustering.
English: Your doctor also needs to know if you are taking potassium supplements or certain diuretics used for heart failure, hypertension and kidney disease, (e.g. amiloride, triamterene, or spironolactone), nonsteroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) used for fever, inflammation and pain, anticoagulants (blood thinners), or oral medicines for diabetes, while you take Advagraf.
Danish: Deres læge skal også vide, om De tager kaliumtilskud eller særlig vanddrivende medicin, som bruges ved hjertesvigt, hypertension og nyresygdom (f.eks. amilorid, triamteren eller spironolacton), nonsteroide anti-inflammatoriske midler (NSAID, f.eks. ibuprofen), som bruges ved feber, betændelsestilstande og smerter, blodfortyndende medicin (antikoagulantia) eller oral medicin mod diabetes (sukkersyge), mens De tager Advagraf.
English: Blood trough levels of tacrolimus should also be closely monitored following conversion from Prograf to Advagraf, dose adjustments, changes in the immunosuppressive regimen, or co-administration of substances which may alter tacrolimus whole blood concentrations (see section 4.5).
Danish: Dalværdierne for tacrolimuskoncentrationerne i blodet bør også monitoreres nøje i følgende tilfælde: ved overgang fra Prograf til Advagraf, ved dosisjusteringer, ved ændring i den immunsuppressive behandling samt ved administration sammen med stoffer, som kan ændre koncentrationen af tacrolimus i fuldblod (se pkt.
English: Clinical efficacy and safety of Prograf capsules bid in primary organ transplantation In prospective studies oral Prograf 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 var oral Prograf primært immunsuppressivum hos omkring 175 lungetransplanterede patienter, 475 pancreastransplanterede patienter og 630 intestinaltransplanterede patienter.
English: Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section
Danish: Immunsystemet Allergiske og anafylaktoide reaktioner er observeret hos patienter, der fik tacrolimus (se pkt.
English: The event rate for biopsy-confirmed acute rejection within the first 24 weeks after transplantation was 18.6% in the Advagraf group (N=331) and 14.9% in the Prograf group (N=336).
Danish: Hyppigheden for biopsibekræftet akut afstødning inden for de første 24 timer efter transplantationen var 18,6 % i Advagrafgruppen (N=331) og 14,9 % i Prografgruppen (N=336).
English: Liver function tests abnormal
Danish: unormale leverfunktionstests
English: The efficacy and safety of Advagraf and Prograf, both in combination with mycophenolate mofetil (MMF) and corticosteroids, was compared in 667 de novo kidney transplant recipients.
Danish: Virkningen og sikkerheden af Advagraf og Prograf, begge i kombination med mycophenolatmofetil (MMF) og kortikosteroider, blev sammenlignet i 667 de novo nyretransplanterede patienter.
English: - The active substance is tacrolimus.
Danish: - Aktivt stof: tacrolimus
English: metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemia uncommon:
Danish: metabolisk acidose, andre elektrolytforstyrrelser, hyponatriæmi, hypervolæmi, hyperurikæmi, hypomagnesæmi, hypokaliæmi, hypokalcæmi, nedsat appetit, hyperkolesterolæmi, hyperlipidæmi, hypertriglyceridæmi, hypofosfatæmi
English: Advagraf therapy should commence at a dose of 0.10 - 0.20 mg/kg/day administered once daily in the morning.
Danish: Behandling med Advagraf bør påbegyndes med en dosis på 0,10 - 0, 20 mg/kg/dag administreret én gang daglig om morgenen.
English: Advagraf therapy should commence at a dose of 0.20 - 0.30 mg/kg/day administered once daily in the morning.
Danish: Behandling med Advagraf bør påbegyndes med en dosis på 0,20 - 0,30 mg/kg/dag administreret én gang daglig om morgenen.
English: The initial oral per protocol dose of tacrolimus was 0.2 mg/kg/day with subsequent dose adjustments to target trough levels of 8 to 15 ng/ml by Day 5 and 5 to 10 ng/ml after Month 6.
Danish: Den initiale orale per protokol dosis af tacrolimus var 0,2 mg/kg/dag med følgende dosisjustering for at opnå dalkoncentrationer på 8 - 15 ng/ml på 5. dagen og 5 - 10 ng/ml efter 6. måned.
English: Other factors observed to increase the risk of these clinical conditions included preexisting heart disease, corticosteroid usage, hypertension, renal or hepatic dysfunction, infections, fluid overload, and oedema.
Danish: Andre faktorer, der kan øge risikoen for disse kliniske tilstande, er tidligere hjertelidelse, behandling med kortikosteroider, hypertension, nedsat nyre- eller leverfunktion, infektion, væskeretention og ødem.
English: anaemia, thrombocytopenia, leukopenia, red blood cell analyses abnormal, leukocytosis uncommon:
Danish: anæmi, trombocytopeni, leukopeni, unormale analyser af røde blodlegemer, leukocytose
English: However, Advagraf is taken once daily, whereas Prograf is taken twice daily.
Danish: Prograf og Advagraf indeholder begge det aktive stof tacrolimus, men Advagraf tages en gang daglig, hvorimod Prograf tages to gange daglig.
English: The combined administration of ciclosporin and tacrolimus should be avoided and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and
Danish: Kombinationsbehandling med ciclosporin og tacrolimus bør undgås, og der skal udvises forsigtighed ved behandling af patienter med tacrolimus, som tidligere har fået ciclosporin (se pkt.
English: Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.
Danish: Profylakse af transplantatafstødning hos voksne nyre- eller levertransplanterede patienter.
English: Blood trough levels of tacrolimus should be monitored during the post-transplantation period.
Danish: Dalværdierne for tacrolimuskoncentrationer i blod bør måles under den postoperative fase.
English: In isolated patients with very high plasma levels, haemofiltration or -diafiltration have been effective in reducing toxic concentrations.
Danish: I nogle få tilfælde med meget høje plasmakoncentrationer har man effektivt kunnet reducere de toksiske koncentrationer med hæmofiltration eller hæmodiafiltration.
English: During subsequent maintenance therapy, blood concentrations have generally been in the range of 5 - 15 ng/ml in liver, kidney and heart transplant recipients.
Danish: Efterfølgende har koncentrationerne i fuldblod generelt ligget på 5 - 15 ng/ml for lever-, nyre- og hjertetransplanterede patienter ved vedligeholdelsesbehandling.
English: In man, the disposition of tacrolimus after intravenous infusion may be described as biphasic.
Danish: Hos mennesker kan tacrolimus farmakokinetik efter intravenøs infusion bedst beskrives med en tocompartment model.
English: The event rate of biopsy confirmed acute rejection within the first 24 weeks after transplantation was 32.6% in the Advagraf group (N=237) and 29.3% in the Prograf group (N=234).
Danish: Hyppigheden af biopsibekræftet akut afstødning inden for de første 24 timer efter transplantation var 32,6 % i Advagrafgruppen (N=237) og 29,3 % i Prografgruppen (N=234).
English: The adverse reaction profile associated with immunosuppressive agents is often difficult to establish owing to the underlying disease and the concurrent use of multiple medicinal products.
Danish: Det er vanskeligt at fastslå bivirkningsprofilen ved immunsuppressiv behandling som følge af den tilgrundliggende lidelse og samtidig indtagelse af flere andre lægemidler.
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.
Danish: Epstein-Bar (EBV) og CMV-infektioner, knoglemarvsforøgelse, samtidig brug af interleukin 2antagonisten daclizumab, lavere initiale doser af tacrolimus med dalkoncentrationer på 10-15 ng/ml og senest bestråling af allotransplantat.
English: Use all the prolonged-release hard capsules within 1 year of opening the aluminium wrapping.
Danish: Brug alle depotkapslerne inden for 1 år efter at aluminiumposen er åbnet.
English: How to take Advagraf
Danish: Sådan skal De tage Advagraf
English: In man tacrolimus has been shown to be able to be absorbed throughout the gastrointestinal tract.
Danish: Hos mennesker er det vist, at tacrolimus kan absorberes i hele mave-tarmkanalen.
English: coagulopathies, pancytopenia, neutropenia, coagulation and bleeding analyses, abnormal rare:
Danish: koagulationsforstyrrelser, pancytopeni, neutropeni, unormale koagulations- og blødningsanalyser
English: The 12-month patient survival rates were 98.6% for Advagraf, 95.7% for Prograf and 97.6% for ciclosporin; in the Advagraf arm 3 patients died (all male), in the Prograf arm 10 patients died (3 female, 7 male) and in the ciclosporin arm 6 patients died (3 female, 3 male).
Danish: Overlevelsesraten efter 12 måneder var 98,6 % for Advagraf, 95,7 % for Prograf og 97,6 % for ciclosporin; i Advagrafgruppen døde 3 patienter (alle mænd), i Prografgruppen døde 10 patienter (3 kvinder, 7 mænd), og i ciclosporingruppen døde 6 patienter (3 kvinder, 3 mænd).
English: 12-month graft survival was 91.5% for Advagraf and 92.8% for Prograf.
Danish: Transplantatoverlevelsen efter 12 måneder var 91,5 % for Advagraf og 92,8 % for Prograf.
English: Careful and frequent monitoring of tacrolimus trough levels is recommended in the first two weeks post-transplant with Advagraf to ensure adequate drug exposure in the immediate post-transplant period.
Danish: For at sikre en fyldestgørende eksponering i begyndelsen af den posttransplanterede periode anbefales det at overvåge tacrolimus' dalværdier omhyggeligt og hyppigt de første to uger med Advagraf efter transplantationen.