FrancophonIA/ELRC3.0 huggingface dataset:
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 transplantationen kan forandre tacrolimus' farmakokinetik, hvilket kan gøre det nødvendigt med yderligere dosisjusteringer.
English: Other interactions potentially leading to increased tacrolimus blood levels Tacrolimus is extensively bound to plasma proteins.
Danish: Andre interaktioner, der potentielt kan forårsage øgede blodkoncentrationer af tacrolimus Tacrolimus bindes kraftigt til plasmaproteiner.
English: What you need to know before you take Envarsus 3.
Danish: Det skal du vide, før du begynder at tage Envarsus 3.
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: På grund af den høje molekylvægt, den ringe vandopløselighed og den stærke binding til erytrocytter og plasmaproteiner forventes tacrolimus ikke at være dialyserbart.
English: Higher Cavg (~50%), reduced peak trough fluctuation (Cmax/Cmin) and a longer Tmax were seen for Envarsus when compared with both, tacrolimus immediate-release formulation (Prograf) and a tacrolimus once daily formulation (Advagraf).
Danish: Højere Cavg (~50 %), reduceret spids-/dalfluktuation (Cmax/Cmin) og længere Tmax blev set for Envarsus sammenlignet med både tacrolimus-formuleringen med øjeblikkelig udløsning (Prograf) og en tacrolimus-formulering, der tages én gang dagligt (Advagraf).
English: In cases of oral intoxication, gastric lavage and/or the use of adsorbents (such as activated charcoal) may be helpful if used shortly after intake.
Danish: I tilfælde af oral overdosering kan maveskylning og/eller administration af absorberende stoffer (f.eks. aktivt kul) kort efter indtagelsen være hensigtsmæssigt.
English: Caution should be exercised when switching combination therapy from ciclosporin, which interferes with enterohepatic recirculation of mycophenolic acid, to tacrolimus, which is devoid of this effect, as this might result in changes of mycophenolic acid exposure.
Danish: Der bør udvises forsigtighed ved skift af kombinationsbehandling fra ciclosporin, der interfererer med enterohepatisk recirkulation af mycophenolsyre, til tacrolimus, som ikke har denne effekt, da det kan medføre ændringer i eksponering for mycophenolsyre.
English: It is necessary to consider the clinical condition of the patient when interpreting whole blood levels.
Danish: Det er nødvendigt at tage patientens kliniske tilstand i betragtning ved vurdering af fuldblodskoncentrationer.
English: If patients taking tacrolimus present with symptoms indicating PRES such as headache, altered mental status, seizures and visual disturbances, a radiological procedure (e.g. MRI) should be performed.
Danish: Hvis patienter, der tager tacrolimus, får symptomer, der indikerer PRES som f.eks. hovedpine, forandret mentaltilstand, krampeanfald og synsforstyrrelser, skal der udføres en radiologisk undersøgelse (f.eks. MR-scanning).
English: - The role of the patient card in ensuring that patients are aware of the product they are taking and the recommendations for safe and effective use in particular once daily dose and the importance of avoiding switching between other tacrolimus containing products except under the advice and supervision of your doctor
Danish: - Den rolle patientens huskekort spiller i at sikre, at patienten er bekendt med det produkt vedkommende tager og anbefalingerne omkring sikker og effektiv anvendelse, især dosering én gang dagligt, og vigtigheden af ikke at skifte mellem andre tacrolimus-indeholdende produkter, med mindre dette sker i samråd med og under tilsyn af vedkommendes læge.
English: Lymphoproliferative disorders and malignancies
Danish: Lymfoproliferative lidelser og maligniteter
English: Possible interactions with other active substances known to have high affinity for plasma proteins should be considered (e.g. NSAIDs, oral anticoagulants or oral antidiabetics).
Danish: Mulige interaktioner med andre aktive lægemidler, der vides at have høj affinitet til plasmaproteiner, bør derfor overvejes (f.eks. NSAID'er, orale antikoagulantia og orale antidiabetika).
English: Dose reduction may be necessary in patients with severe liver impairment (see section 4.2).
Danish: Dosisreduktion kan være nødvendig hos patienter med svært nedsat leverfunktion (se pkt.
English: This can lead to graft rejection or increased incidence of adverse reactions, 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: Reproductive system and breast disorders dysmenorrhoea and uterine bleeding
Danish: Det reproduktive system og mammae dysmenoré og uterin blødning
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: Blandt andre potentielle interaktioner, som kan øge den systemiske eksponering for tacrolimus, er prokinetiske midler (f.eks. metoclopramid og cisaprid), cimetidin og magnesium-aluminium-hydroxid.
English: The pharmacokinetics, efficacy and safety of Envarsus and tacrolimus immediate-release capsules, both in combination with corticosteroids were compared in 117 liver transplant recipients, of whom 88 received treatment with Envarsus.
Danish: Farmakokinetik, virkning og sikkerhed af Envarsus og tacrolimus-kapsler med øjeblikkelig udløsning, begge i kombination med kortikosteroider, blev sammenlignet hos 117 levertransplanterede patienter, hvoraf 88 blev behandlet med Envarsus.
English: Treatment of allograft rejection after kidney or liver transplantation For conversion from other immunosuppressants to once daily tacrolimus, treatment should begin with the initial oral dose recommended in kidney and liver transplantation respectively for prophylaxis of transplant rejection.
Danish: Behandling af allograft-afstødning efter nyre- og levertransplantation Ved skift fra andre immunsuppressive lægemidler til tacrolimus én gang dagligt skal behandlingen påbegyndes med den anbefalede, orale initialdosis ved hhv. nyre- og levertransplantation for profylakse af transplantatafstødning.
English: Blood trough levels of tacrolimus should be monitored during the post-transplantation period.
Danish: Dalkoncentrationerne for tacrolimus i blodet skal monitoreres i perioden efter transplantationen.
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 forsigtig med at sammenligne koncentrationer nævnt i offentliggjort litteratur med individuelle værdier i klinisk praksis uden at vide, hvilke assaymetoder der er benyttet.
English: EBV-Viral Capsid Antigen (VCA)-negative patients have been reported to have an increased risk of developing lymphoproliferative disorders.
Danish: Det er rapporteret, at EBV-Viral Capsid Antigen (VCA)-negative patienter har øget risiko for at udvikle lymfoproliferative lidelser.
English: There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall.
Danish: Der er også påvist gastrointestinal metabolisme via CYP3A4 i tarmvæggen.
English: If you stop taking Envarsus
Danish: Hvis du holder op med at tage Envarsus
English: Envarsus should generally be taken on an empty stomach to achieve maximal absorption (see section 5.2).
Danish: Envarsus bør generelt indtages på tom mave for at opnå maksimal absorption (se pkt.
English: Tacrolimus is also considerably metabolised in the intestinal wall.
Danish: Tacrolimus metabiliseres også i betydeligt omfang i tarmvæggen.
English: EXP Use all the prolonged-release tablets within 45 days of opening the aluminium wrapping.
Danish: EXP Brug alle depottabletterne inden for 45 dage efter åbning af alufolieemballagen.
English: In comparison to Caucasians, black patients may require higher tacrolimus doses to achieve similar trough levels.
Danish: Sammenlignet med kaukasere kan sorte patienter have behov for en højere dosis af tacrolimus for at opnå samme dalkoncentration.
English: When converting from tacrolimus immediate-release products (e.g. Prograf capsules) or from Advagraf prolonged-release capsules to Envarsus, trough levels should be measured prior to conversion and within two weeks after conversion.
Danish: Ved skift fra tacrolimus-præparater med øjeblikkelig udløsning (f.eks. Prograf-kapsler) eller fra Advagraf-depotkapsler til Envarsus bør dalkoncentrationerne måles før skiftet og inden for to uger efter skiftet.
English: Several cases of accidental overdose have been reported with tacrolimus.
Danish: Der er rapporteret om adskillige tilfælde af utilsigtet overdosering med tacrolimus.
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 immunsuppressive lægemidler, såsom antilymfocytiske antistoffer (f.eks. basiliximab, daclizumab), givet samtidigt, øger risikoen for EBV-associerede lymfoproliferative lidelser.
English: Effect of other medicinal products on the metabolism of tacrolimus
Danish: Andre lægemidlers virkning på metabolismen af tacrolimus
English: Tacrolimus is widely metabolised in the liver, primarily by the cytochrome P450-3A4.
Danish: Tacrolimus metaboliseres i udstrakt grad i leveren, primært af cytokrom P450-3A4.
English: How long should I take the Envarsus tablets
Danish: Hvor længe skal jeg tage Envarsustabletterne?
English: Patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal).
Danish: Patienter, der får tacrolimus, har hyppigt øget risiko for infektioner (virus, bakterier, svampe og protozoer).
English: Gastrointestinal perforation has been reported in patients treated with tacrolimus.
Danish: Der er rapporteret gastrointestinal perforation hos patienter behandlet med tacrolimus.
English: Use all the prolonged-release tablets within 45 days of opening the aluminium wrapping.
Danish: Brug alle depottabletterne inden for 45 dage efter åbning af alufoliepakningen.
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: Contents of the pack and other information What Envarsus contains
Danish: Pakningsstørrelser og yderligere oplysninger Envarsus indeholder:
English: Italy or
Danish: Italien eller
English: Maintenance doses of corticosteroids have been shown to reduce tacrolimus blood levels.
Danish: Vedligeholdelsesdoser af kortikosteroider har vist sig at reducere blodkoncentrationerne af tacrolimus.
English: In clinical studies patients converted from twice daily Prograf were converted to Envarsus at 1:0.85 (mg:mg).
Danish: I kliniske studier skiftede patienter fra Prograf to gange dagligt til en dosis Envarsus på 1:0,85 (mg:mg).
English: Conversion from ciclosporin to tacrolimus
Danish: Skift fra behandling med ciclosporin til tacrolimus
English: Pack sizes of 30, 60 and 90 prolonged-release tablets.
Danish: Pakningsstørrelser med 30, 60 og 90 depottabletter.
English: How should I take the Envarsus tablets Envarsus is taken orally once daily, generally on an empty stomach.
Danish: Envarsus tages gennem munden én gang dagligt, sædvanligvis på tom mave.
English: The treatment difference (Envarsus-Prograf) was 0% (95% confidence interval [4.21%, 4.21%]).
Danish: Behandlingsforskellen (Envarsus-Prograf) var 0 % (95 % konfidensinterval [-4,21 %, 4,21 %]).
English: If you forget to take Envarsus
Danish: Hvis du har glemt at tage Envarsus
English: If clinically relevant changes are seen, adjustments of the immunosuppressive regimen should be considered.
Danish: Hvis der ses klinisk relevante ændringer, skal det overvejes at ændre det immunsuppressive regime.
English: Other medicines and Envarsus
Danish: Brug af anden medicin sammen med Envarsus
English: Drugs which interfere with mycophenolic acid's enterohepatic cycle have potential to reduce the plasma level and efficacy of mycophenolic acid.
Danish: Lægemidler, der interfererer med mycophenolsyres enterohepatiske cyklus kan potentielt reducere plasmaniveauet og virkningen af mycophenolsyre.
English: Envarsus contains the active substance tacrolimus.
Danish: Envarsus indeholder det aktive stof tacrolimus.
English: Therefore, you should not breast-feed whilst taking Envarsus.
Danish: Derfør bør du ikke amme, mens du tager Envarsus.
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 periode efter transplantationen skal følgende parametre kontrolleres rutinemæssigt: blodtryk, ekg, neurologisk og visuel status, fastende blodsukker, elektrolytter (især kalium), lever- og nyrefunktionstest, bestemmelse af hæmatologiske parametre, koagulationsværdier og plasmaprotein.
English: - The active substance is tacrolimus.
Danish: - Aktivt stof: tacrolimus.
English: Ear and labyrinth disorders tinnitus hypoacusis deafness neurosensory hearing impaired
Danish: Øre og labyrint tinnitus hypoakusis neurosensorisk døvhed nedsat hørelse
English: The patient card should include information on the following key elements: - The product name - That the dose is once daily - The importance of avoiding switching between other tacrolimus containing products except under the advice and supervision of physicians.
Danish: Hvert huskekort til patienter skal indeholde oplysninger om de følgende hovedpunkter: - Produktnavnet - At dosen er én gang dagligt - Vigtigheden af at undgå at skifte mellem andre tacrolimus-indeholdende produkter, med mindre dette sker i samråd med og under tilsyn af en læge.
English: High dose prednisolone or methylprednisolone administered for the treatment of acute rejection have the potential to increase or decrease tacrolimus blood levels.
Danish: Administration af høje doser prednisolon eller methylprednisolon til behandling af akut afstødning kan potentielt øge eller nedsætte blodkoncentrationerne af tacrolimus.
English: In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity (see section 5.3).
Danish: Hos rotter og kaniner forårsagede tacrolimus embryoføtal toksicitet ved doser, som var toksiske for moderen (se pkt.
English: PVC blisters containing 10 prolonged-release tablets.
Danish: PVC-blisterkort med 10 depottabletter.
English: Results from clinical studies performed with once-daily tacrolimus
Danish: Resultater fra kliniske studier med tacrolimus, der tages én gang dagligt
English: Via San Leonardo 96 43122 Parma Italy
Danish: Via San Leonardo 96 43122 Parma Italien
English: If you need to have any vaccinations, please tell your doctor before.
Danish: Hvis du har behov for at blive vaccineret, skal din læge oplyses herom, inden det sker.
English: Envarsus therapy should commence at a dose of 0.11-0.13 mg/kg/day administered once daily in the morning.
Danish: Behandling med Envarsus bør påbegyndes med en dosis på 0,11-0,13 mg/kg/dag administreret én gang dagligt om morgenen.
English: The overall incidence of fatal treatment emergent adverse events for the combined de novo and stable liver transplant population was not significantly different between the Envarsus group and the tacrolimus immediate-release group.
Danish: Den totale forekomst af fatale behandlingsafledte bivirkninger for den kombinerede de novo og stabile levertransplantatpopulation var ikke signifikant forskellig mellem Envarsus-gruppen og tacrolimus-gruppen med øjeblikkelig udløsning.
English: The efficacy and safety of Envarsus and Prograf, both in combination with mycophenolate mofetil (MMF) or mycophenolate sodium (MPS) and corticosteroids, were compared in 324 stable kidney transplant recipients.
Danish: Envarsus' og Prografs virkning og sikkerhed, både i kombination med mycophenolatmofetil (MMF) eller mycophenolatnatrium (MPS) og kortikosteroider, blev sammenlignet hos 324 stabile nyretransplanterede patienter.
English: Clinical data suggest that the pharmacokinetics of statins are largely unaltered by the co-administration of tacrolimus.
Danish: Kliniske data tyder på, at statiners farmakokinetik stort set er uændret ved samtidig brug af tacrolimus.
English: - The other excipients are hypromellose, lactose monohydrate, macrogol 6000, poloxamer 188, magnesium stearate, tartaric acid (E334), butylated hydroxytoluene (E321), dimethicone 350.
Danish: - Øvrige indholdsstoffer (hjælpestoffer): hypromellose, lactosemonohydrat, macrogol 6000, poloxamer 188, magnesiumstearat, vinsyre (E334), butylhydroxytoluen (E321), dimeticon 350.
English: The event rate of biopsy-confirmed acute rejection within the 360-day study period was not significantly different between the Envarsus group and the tacrolimus immediate-release group.
Danish: Bivirkningsraten af biopsibekræftet akut afstødning i den 360-dages studieperiode var ikke signifikant forskellig mellem Envarsus-gruppen og tacrolimus-gruppen med øjeblikkelig udløsning.
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 skal det overvejes at ændre det immunsuppressive regime.
English: Envarsus therapy should commence at a dose of 0.17 mg/kg/day administered once daily in the morning.
Danish: Behandling med Envarsus bør påbegyndes med en dosis på 0,17 mg/kg/dag administreret én gang dagligt om morgenen.
English: Patients treated with immunosuppressants, including Envarsus, 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, der behandles med immunsuppressive lægemidler, herunder Envarsus, har øget risiko for infektioner, herunder opportunistiske infektioner (med bakterier, svampe, vira og protozoer) såsom BK-virus-associeret nefropati og JC-virus-associeret progressiv multifokal leukoencefalopati (PML).
English: The treatment difference (Envarsus-Prograf) was -1.35% (95% confidence interval [-7.94%, 5.27%]).
Danish: Behandlingsforskellen (Envarsus-Prograf) var -1,35 % (95 % konfidensinterval [7,94 %, 5,27 %]).
English: Envarsus 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 Envarsus skal baseres primært på kliniske vurderinger af afstødning og tolerans hos den enkelte patient vejledt af monitorering af blodkoncentrationen (se nedenfor under “Terapeutisk lægemiddelmonitorering”).
English: The use of live attenuated vaccines should be avoided (see section 4.4).
Danish: Anvendelse af levende, afsvækkede vacciner bør undgås (se pkt.
English: Treatment emergent fatal adverse events occurred in 1.2% of Envarsus patients and 0.6% of Prograf patients.
Danish: Behandlingsafledte, fatale bivirkninger forekom hos 1,2 % af Envarsus-patienter og 0,6 % af Prograf-patienter.
English: If abnormalities develop, dose reduction of tacrolimus or change of treatment to another immunosuppressive agent should be considered.
Danish: Ved tegn på anomalier bør dosis af tacrolimus reduceres, eller det bør overvejes at skifte til et andet immunsuppressivt lægemiddel.
English: Patients treated with tacrolimus have been reported to develop Epstein-Barr Virus (EBV)-associated lymphoproliferative disorders (see section 4.8).
Danish: Det er rapporteret, at patienter, som får behandling med tacrolimus, har udviklet Epstein-Barr virus (EBV)-associerede lymfoproliferative lidelser (se pkt.
English: The treatment failure rate using the same composite end-point with centrally read BPAR was 1.9% in the Envarsus group and 3.7% in the Prograf group (95% confidence interval [6.51%, 2.31%]).
Danish: Raten af behandlingssvigt ved brug af samme sammensatte endepunkt med centralt aflæst BPAR var 1,9 % i Envarsus-gruppen og 3,7 % i Prograf-gruppen (95 % konfidensinterval [-6,51 %, 2,31 %]).
English: Weaker interactions have been observed with clotrimazole, clarithromycin, josamycin, nifedipine, nicardipine, diltiazem, verapamil, amiodarone, danazol, ethinylestradiol, omeprazole and nefazodone.
Danish: Svagere interaktioner er observeret med clotrimazol, clarithromycin, josamycin, nifedipin, nicardipin, diltiazem, verapamil, amiodaron, danazol, ethinylestradiol, omeprazol og nefazodon.
English: The relationship between tacrolimus trough levels (C24) and systemic exposure (AUC0-24) for Envarsus is similar to that of immediate-release tacrolimus.
Danish: Forholdet mellem tacrolimus-dalkoncentrationer (C24) og systemisk eksponering (AUC0-24) for Envarsus er sammenlignelig med det for tacrolimus med øjeblikkelig udløsning.
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: Din læge vil beregne den rigtige startdosis for at forebygge afstødning af det transplanterede organ ud fra din kropsvægt.
English: The efficacy and safety of Envarsus and Prograf, both in combination with mycophenolate mofetil (MMF), corticosteroids and IL-2 receptor antagonist as per the standard of care were compared in a randomised, double-blind, double-dummy study, in 543 de novo kidney transplant recipients.
Danish: Envarsus' og Prografs virkning og sikkerhed, både i kombination med mycophenolatmofetil (MMF) kortikosteroider, og IL-2 receptor-antagonist i henhold til standardbehandling blev sammenlignet i et randominseret, dobbeltblindt, dobbelt-dummy studie hos 543 de novo nyretransplanterede patienter.
English: Injury, poisoning and procedural complications primary graft dysfunction
Danish: Traumer, forgiftninger og behandlingskomp likationer primær dysfunktion af transplantatet
English: The dose may vary depending upon the immunosuppressive regimen chosen.
Danish: Afhængigt af det valgte, immunsuppressive regime kan dosen variere.
English: Blood trough levels of tacrolimus should also be closely monitored following conversion from tacrolimus products, dose adjustments, changes in the immunosuppressive regimen, or co-administration of substances which may alter tacrolimus whole blood concentrations (see section 4.5).
Danish: Dalkoncentrationerne for tacrolimus i blodet bør også monitoreres nøje efter skift fra tacrolimus-præparater, dosisjustering, ændring i det immunsuppressive regime eller ved samtidig administration af stoffer, der kan ændre koncentrationen af tacrolimus i fuldblod (se pkt.
English: Tacrolimus has been shown to increase the blood level of phenytoin.
Danish: Det er påvist, at tacrolimus øger blodkoncentrationen af fenytoin.
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 and (triacetyl)oleandomycin.
Danish: In vitro har følgende lægemidler vist sig at være potentielle hæmmere af tacrolimus-metabolisme: bromocriptin, kortison, dapson, ergotamin, gestoden, lidocain, mephenytoin, miconazol, midazolam, nilvadipin, norethindron, quinidin, tamoxifen og (triacetyl)oleandomycin.