FrancophonIA/ELRC3.0 huggingface dataset:
English: Envarsus is used to control your body's immune response, enabling your body to accept the transplanted organ.
Danish: Envarsus anvendes til at kontrollere kroppens immunreaktion, så kroppen kan acceptere det transplanterede organ.
English: Experience with overdose is limited.
Danish: Der er begrænset erfaring med overdosering.
English: - if you are taking any medicines mentioned below under “Other medicines and Envarsus”.
Danish: - hvis du tager medicin angivet nedenfor under ”Brug af anden medicin sammen med Envarsus”.
English: Mean values for Cmax, percentage degree of fluctuation and percentage degree of swing were significantly lower with administration of Envarsus tablets.
Danish: Gennemsnitsværdier for Cmax, procentgrad af fluktuation og procentgrad af udsving var signifikant lavere ved administration af Envarsus-tabletter.
English: Therefore, Envarsus should generally be taken on an empty stomach to achieve maximal absorption.
Danish: Derfor bør Envarsus generelt indtages på tom mave for at opnå maksimal absorption.
English: Reversible cardiotoxic effects were observed in rabbits following intravenous administration of tacrolimus.
Danish: Der blev observeret reversible kardiotoksiske virkninger hos kaniner efter intravenøs administration af tacrolimus.
English: In clinical practice, whole blood trough levels have generally been in the range of 5-20 ng/mL in kidney transplant patients in the early post-transplant period, and 5-15 ng/mL during subsequent maintenance therapy.
Danish: I klinisk praksis har fuldsblods dalkoncentrationerne generelt ligget på 5-20 ng/ml hos nyretransplanterede patienter i den tidlige periode efter transplantationen og 5-15 ng/ml under efterfølgende vedligeholdelsesbehandling.
English: In plasma, tacrolimus is highly bound (>98.8%) to plasma proteins, mainly to serum albumin and α-1-acid glycoprotein.
Danish: I plasma bindes tacrolimus stærkt (>98,8 %) til plasmaproteiner, hovedsagelig til serumalbumin og α-1-syreglycoprotein.
English: Concomitant use of these substances may require decreased tacrolimus doses in nearly all patients.
Danish: Samtidig brug af disse lægemidler kan gøre det nødvendigt at reducere dosis af tacrolimus hos næsten alle patienter.
English: Embryofoetal toxicity was observed in rats and rabbits and was limited to doses that caused significant toxicity in maternal animals.
Danish: Embryoføtal toksicitet blev observeret hos rotter og kaniner, men var begrænset til doser, som forårsagede signifikant toksicitet hos moderdyr.
English: Therefore, metabolites do not contribute to the pharmacological activity of tacrolimus.
Danish: Derfor bidrager metabolitter ikke til tacrolimus' farmakologiske aktivitet.
English: How much Envarsus do I have to take
Danish: Hvor meget Envarsus skal jeg tage?
English: Tacrolimus may prolong the QT interval but at this time lacks substantial evidence for causing Torsades de Pointes.
Danish: Tacrolimus kan forlænge QT-intervallet, men der mangler væsentlig evidens for, at det forårsager Torsades de Pointes.
English: There is limited experience in non-Caucasian patients and patients at elevated immunological risk (e.g. retransplantation, evidence of panel reactive antibodies, PRA).
Danish: Der er begrænset erfaring med ikke-kaukasiske patienter og patienter med forhøjet immunologisk risiko (f.eks. retransplantation, tegn på panel reaktive antistoffer, PRA).
English: Store in the original aluminium foil wrapper in order to protect from light.
Danish: Opbevares i den originale alufoliepakning for at beskytte mod lys.
English: In case of in utero exposure, monitoring of the newborn for potential adverse events of tacrolimus is recommended (in particular, effects on the kidneys).
Danish: I tilfælde af eksponering in utero anbefales det at monitorere den nyfødte for potentielle bivirkninger af tacrolimus (især virkningen på nyrerne).
English: Patients should be advised to report changes in visual acuity, changes in colour vision, blurred vision, or visual field defect, and in such cases, prompt evaluation is recommended with referral to an ophthalmologist as appropriate.
Danish: Patienterne bør rådes til at indberette ændringer i synets skarphed, ændringer i farvesynet, sløret syn eller defekter i synsfeltet, og i sådanne tilfælde anbefales hurtig vurdering med henvisning til en øjenlæge efter behov.
English: Avoid grapefruit (also as juice) while on treatment with Envarsus, since it can affect its levels in the blood.
Danish: Undgå grapefrugt (også grapefrugtjuice), mens du behandles med Envarsus, da det kan påvirke koncentrationerne af Envarsus i blodet.
English: Only one of these has been shown in vitro to have immunosuppressive activity similar to that of tacrolimus.
Danish: Kun en enkelt af disse har vist sig at have immunsuppressiv aktivitet in vitro, der ligner tacrolimus'.
English: There is no evidence that male and female patients require different doses to achieve similar trough levels.
Danish: Der er ikke evidens for, at mandlige og kvindelige patienter har behov for forskellig dosis for at opnå samme dalkoncentration.
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the half-life of pentobarbital and antipyrine.
Danish: Data fra dyrestudier har vist, at tacrolimus potentielt kan reducere clearance og øge halveringstiden for pentobarbital og antipyrin.
English: It is an immunosuppressant.
Danish: Det er et immunhæmmende lægemiddel.
English: - if you are allergic to sirolimus or to any macrolide-antibiotic (e.g. erythromycin, clarithromycin, josamycin).
Danish: - hvis du er allergisk over for sirolimus eller et makrolid-antibiotikum (f.eks. erythromycin, clarithromycin, josamycin).
English: All patients reported risk factors for PRCA such as parvovirus B19 infection, underlying disease or concomitant medicinal product associated with PRCA.
Danish: Alle patienter rapporterede risikofaktorerne for PRCA som f.eks. parvovirus B19-infektion, tilgrundliggende sygdom eller samtidig behandling med lægemidler i forbindelse med PRCA.
English: - if you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for tacrolimus eller et af de øvrige indholdsstoffer i Envarsus (angivet i punkt 6).
English: You will need to take Envarsus every day as long as you need immunosuppression to prevent rejection of your transplanted organ.
Danish: Du skal tage Envarsus hver dag, så længe du har brug for immundæmpende lægemidler for at forebygge afstødning af dit transplanterede organ.
English: At the molecular level, the effects of tacrolimus appear to be mediated by binding to a cytosolic protein (FKBP12) which is responsible for the intracellular accumulation of the compound.
Danish: På molekylært niveau synes virkningen af tacrolimus at være medieret af binding til et cytosolprotein (FKBP12), som er ansvarligt for den intracellulære akkumulation af stoffet.
English: Immunosuppressants may affect the response to vaccination, and vaccination during treatment with tacrolimus may be less effective.
Danish: Immunsuppressive lægemidler kan påvirke responset på vaccination, og vaccination under behandling med tacrolimus kan være mindre effektiv.
English: The half-life of tacrolimus is long and variable.
Danish: Tacrolimus har en lang og variabel halveringstid.
English: Ostenfelder Strasse 51-61 D-59320 Ennigerloh Germany
Danish: Ostenfelder Strasse 51-61 D-59320 Ennigerloh Tyskland
English: Initial daily doses just after transplantation will generally be in the range of: 0.11 - 0.17 mg per kg body weight per day depending on the transplanted organ.
Danish: Den første daglige dosis efter transplantationen vil generelt være inden for området: 0,11 - 0,17 mg pr. kg kropsvægt pr. dag, afhængigt af hvilket organ der er transplanteret.
English: Pharmacotherapeutic group: Immunosuppressants, calcineurin inhibitors, ATC code: L04AD02
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, calcineurinhæmmere, ATC-kode: L04AD02
English: Pharmacokinetics studies have indicated that the increase in blood levels is mainly a result of increase in oral bioavailability of tacrolimus owing to the inhibition of gastrointestinal metabolism.
Danish: Farmakokinetiske studier har vist, at stigningen i blodkoncentrationer hovedsagelig er et resultat af stigningen i den orale biotilgængelighed af tacrolimus på grund af hæmningen af gastrointestinal metabolisme.
English: In practice, tacrolimus-based therapy has been initiated 12 to 24 hours after discontinuation of ciclosporin.
Danish: I praksis kan behandling med tacrolimus påbegyndes 12 - 24 timer efter seponering af ciclosporinbehandlingen.
English: Monitoring of ciclosporin blood levels should be continued following conversion as the clearance of ciclosporin might be affected.
Danish: Monitorering af ciclosporinblodkoncentrationer skal fortsættes efter skiftet, da ciclosporins clearance kan være påvirket.
English: You may also be given Envarsus for an ongoing rejection of your transplanted liver, kidney, heart or other organ when any previous treatment you were taking was unable to control this immune response after your transplantation.
Danish: Du kan også få Envarsus ved en igangværende afstødning af den transplanterede lever, nyre, hjerte eller andet organ, når din tidligere behandling ikke har kunnet kontrollere immunforsvarets reaktion efter transplantationen.
English: Therapeutic drug monitoring of mycophenolic acid may be appropriate when switching from ciclosporin to tacrolimus or vice versa.
Danish: Terapeutisk lægemiddelmonitorering af mycophenolsyre kan være relevant ved skift fra ciclosporin til tacrolimus eller vice versa.
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 er der observeret værdier på hhv. 4,1 l/time, 6,7 l/time og 3,9 l/time.
English: Grapefruit juice has been reported to increase the blood level of tacrolimus and should, therefore, be avoided.
Danish: Det er rapporteret, at grapefrugtjuice øger blodkoncentrationen af tacrolimus og bør derfor undgås.
English: In man, the disposition of tacrolimus after intravenous infusion may be described as biphasic.
Danish: Hos mennesker kan fordelingen af tacrolimus efter intravenøs infusion beskrives som bifasisk.
English: As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving Envarsus.
Danish: Da skadelige virkninger på den nyfødte ikke kan udelukkes, bør kvinder i behandling med Envarsus ikke amme.
English: Take the tablets immediately following removal from the blister.
Danish: Tag tabletterne, lige efter de er taget ud af blisteren.
English: Patients treated with tacrolimus have been reported to develop posterior reversible encephalopathy syndrome (PRES).
Danish: Det er rapporteret, at patienter, som får behandling med tacrolimus, har udviklet posterior reversibel encefalopati-syndrom (PRES).
English: <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden
English: As an aid to optimise dosing, several immunoassays are available for determining tacrolimus concentrations in whole blood.
Danish: Som hjælp til at optimere doseringen findes der adskillige immunassays til bestemmelse af koncentrationer af tacrolimus i fuldblod.
English: Human data show that tacrolimus crosses the placenta.
Danish: Humane data viser, at tacrolimus passerer placenta.
English: From time to time, your doctor may need to do blood, urine, heart, or eye tests, to set the right dose of Envarsus.
Danish: Fra tid til anden kan det være nødvendigt for lægen at tage blod- og urinprøver eller at undersøge dit hjerte og dine øjne for at fastslå den korrekte dosis af Envarsus.
English: Effect of tacrolimus on the metabolism of other medicinal products
Danish: Tacrolimus' virkning på metabolismen af andre lægemidler
English: Since levels of tacrolimus in blood may significantly change during diarrhoea episodes, extra monitoring of tacrolimus concentrations is recommended during episodes of diarrhoea.
Danish: Da blodets indhold af tacrolimus kan ændres signifikant under episoder med diarré, anbefales ekstra monitorering af tacrolimuskoncentrationer under episoder med diarré.
English: Your doctor may need to adjust your dose of Envarsus or will decide to stop treatment with tacrolimus.
Danish: Det kan være nødvendigt for lægen at justere din dosis af Envarsus, eller lægen kan beslutte at stoppe behandlingen med tacrolimus.
English: Increased doses of tacrolimus, supplemental corticosteroid therapy, and introduction of short courses of mono-/polyclonal antibodies have all been used to manage rejection episodes.
Danish: Øgede doser af tacrolimus, supplerende kortikosteroidbehandling og introduktion af korte behandlingsforløb med mono-/polyklonale antistoffer er alle blevet benyttet til at behandle afstødningsepisoder.
English: Envarsus is a prolonged-release formulation of tacrolimus resulting in an extended oral absorption profile with an average time to maximum blood concentration (Cmax) of approximately 6 hours (tmax) at steady state.
Danish: Envarsus er en depotformulering af tacrolimus med forlænget udløsning, hvilket medfører en forlænget oral absorptionsprofil med en gennemsnitlig tid til maksimal blodkoncentration (Cmax) på ca. 6 timer (tmax) ved steady state.
English: In systemic circulation only one of the inactive metabolites is present at low concentrations.
Danish: I det systemiske kredsløb findes der kun lave koncentrationer af en enkelt af de inaktive metabolitter.
English: What you need to know before you take Envarsus Do not take Envarsus:
Danish: Det skal du vide, før du begynder at tage Envarsus Tag ikke Envarsus:
English: In isolated patients with very high plasma levels, haemofiltration or -diafiltration have been effective in reducing toxic concentrations.
Danish: Hos enkelte patienter med meget høje plasmakoncentrationer har hæmofiltration eller -diafiltration været effektivt til at reducere toksiske koncentrationer.
English: Less than 1% of unchanged tacrolimus was detected in the urine and faeces, indicating that tacrolimus is almost completely metabolised prior to elimination bile being the principal route of elimination.
Danish: Mindre end 1 % af uomdannet tacrolimus blev fundet i urin og fæces, hvilket indikerer, at tacrolimus bliver næsten fuldstændigt metaboliseret inden elimination.
English: Stopping your treatment with Envarsus may increase the risk of rejection of your transplanted organ.
Danish: Hvis du ophører med din behandling med Envarsus, kan det øge risikoen for afstødning af det transplanterede organ.
English: If you have accidentally taken too much Envarsus, contact your doctor or nearest hospital emergency department immediately.
Danish: Hvis du ved en fejltagelse har taget for mange Envarsus-tabletter, skal du straks kontakte din læge eller nærmeste skadestue.
English: Tacrolimus suppresses T-cell activation and T-helper-cell dependent B-cell proliferation, as well as the formation of lymphokines (such as interleukins-2, -3, and γ-interferon) and the expression of the interleukin-2 receptor.
Danish: Tacrolimus undertrykker T-celleaktivering og T-hjælpecelle-afhængig B-celleproliferation samt dannelsen af lymfokiner (f.eks. interleukin 2, -3 og γ-interferon) og ekspressionen af interleukin-2-receptoren.
English: Following conversion to any alternative formulation, therapeutic drug monitoring must be performed and dose adjustments made to ensure that systemic exposure to tacrolimus is maintained.
Danish: Efter skift til enhver anden formulering er det nødvendigt at foretage terapeutisk lægemiddelmonitorering og at justere dosis for at sikre, at den systemiske eksponering for tacrolimus opretholdes.
English: Tacrolimus blood trough levels should be determined approximately 24 hours post-dosing of Envarsus, just prior to the next dose.
Danish: Dalkoncentrationerne for tacrolimus i blodet skal bestemmes ca. 24 timer efter dosering af Envarsus, umiddelbart før næste dosis.
English: In healthy subjects, the mean half-life in whole blood is approximately 30 hours.
Danish: Hos raske forsøgspersoner er den gennemsnitlige halveringstid i fuldblod ca. 30 timer.
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, estimeret ud fra fuldblodskoncentrationerne, 2,25 l/time.
English: The steady-state volume of distribution based on plasma concentrations is approximately 1,300 L (healthy subjects).
Danish: Baseret på plasmakoncentrationerne er fordelingsvolumenet ved steady state ca. 1.300 l (hos raske forsøgspersoner).
English: Tacrolimus reduces your body's defence mechanism (immune system), which will not be as good at fighting infections.
Danish: Tacrolimus hæmmer kroppens forsvarsmekanisme (immunforsvar), som derefter ikke vil kunne bekæmpe infektioner så godt som normalt.
English: This is because immunosuppressants could increase the risk of skin cancer.
Danish: Dette skyldes at lægemidlet hæmmer immunforsvaret og derfor kan det øge risikoen for hudkræft.
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 antikonceptionsmidler og dermed øge hormoneksponeringen, skal der udvises særlig omhu ved valg af antikonceptionsmidler.
English: A strong correlation exists between AUC and whole blood trough levels at steady-state for Envarsus.
Danish: Der er god korrelation mellem AUC og dalkoncentrationerne i fuldblod ved steady-state for Envarsus.
English: In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly responsible for graft rejection.
Danish: Tacrolimus hæmmer især dannelsen af cytotoksiske lymfocytter, som hovedsagelig er årsagen til transplantatafstødning.
English: Treatment of allograft rejection
Danish: Behandling af allograft-afstødning
English: Corresponding data based on whole blood averaged 47.6 L.
Danish: Baseret på fuldblodskoncentrationerne er den i gennemsnit 47,6 l.
English: Limited data from organ transplant recipients show no evidence of an increased risk of adverse events on the course and outcome of pregnancy under tacrolimus treatment compared with other immunosuppressive medicinal products.
Danish: Begrænsede data fra organtransplanterede patienter viser ingen tegn på øget risiko for bivirkninger på selve graviditeten og dens forløb ved behandling med tacrolimus sammenlignet med andre immunsuppressive lægemidler.
English: Enhanced nephrotoxicity has been observed following the administration of amphotericin B and ibuprofen in conjunction with tacrolimus.
Danish: Der er observeret øget nefrotoksicitet efter administration af amphotericin B og ibuprofen samtidig med tacrolimus.
English: Envarsus is supplied in PVC blisters containing 10 tablets.
Danish: Envarsus leveres i PVC-blisterkort med 10 tabletter.
English: The oral bioavailability is approximately 40% higher for Envarsus as compared to the same dose of tacrolimus immediate-release formulation (Prograf) in kidney transplant patients.
Danish: Den orale biotilgængelighed er ca. 40 % højere for Envarsus sammenlignet med den samme dosis af formuleringen af tacrolimus med øjeblikkelig udløsning (Prograf) hos nyretransplanterede patienter.
English: Effect on hepatic clearance is less pronounced.
Danish: Virkningen på leverclearance er mindre markant.
English: Afterwards regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time.
Danish: Herefter vil din læge jævnligt tage blodprøver for at bestemme den korrekte dosis og justere dosen fra tid til anden.
English: Patients are also at an increased risk of infections with viral hepatitis (e.g. hepatitis B and C reactivation and de novo infection, as well as hepatitis E, which may become chronic).
Danish: Patienterne har desuden en øget risiko for infektion med viral hepatitis (f.eks. reaktivering af infektion og de novo-infektion med hepatitis B og C samt hepatitis E, som kan blive kronisk).
English: Tacrolimus is extensively distributed in the body.
Danish: Tacrolimus fordeles ekstensivt i kroppen.
English: In the systemic circulation, tacrolimus binds strongly to erythrocytes resulting in an approximate 20:1 distribution ratio of whole blood/plasma concentrations.
Danish: I det systemiske kredsløb bindes tacrolimus stærkt til erytrocytter, hvilket medfører et fordelingsforhold på ca. 20:1 i fuldblods-/plasmakoncentrationer.
English: Carbamazepine, metamizole and isoniazid have the potential to decrease tacrolimus concentrations.
Danish: Carbamazepin, metamizol og isoniazid kan også potentielt nedsætte koncentrationerne af tacrolimus.
English: If PRES is diagnosed, adequate blood pressure and seizure control and immediate discontinuation of systemic tacrolimus is advised.
Danish: Hvis PRES diagnosticeres, tilrådes det, at der udføres passende blodtryks- og anfaldskontrol, samt at systemisk tacrolimus omgående seponeres.
English: Magnesium stearate Tartaric acid (E334) Butylated hydroxytoluene (E321) Dimethicone 350
Danish: Magnesiumstearat Vinsyre (E334) Butylhydroxytoluen (E321) Dimeticon 350
English: Tacrolimus is a low-clearance substance.
Danish: Tacrolimus er et stof med lav clearance.
English: No specific antidote to tacrolimus therapy is available.
Danish: Der findes ingen specifik antidot mod tacrolimus-behandling.
English: Data from clinical studies suggest that the majority of patients can be successfully managed if tacrolimus blood trough levels are maintained below 20 ng/mL.
Danish: Data fra kliniske studier antyder, at behandlingen forløber godt hos de fleste patienter, hvis bloddalkoncentrationerne for tacrolimus holdes under 20 ng/ml.
English: Following your kidney or liver transplant, your body's immune system will try to reject the new organ.
Danish: Efter en nyreeller levertransplantation vil din krops immunforsvar forsøge at afstøde det nye organ.
English: It should be noted that black patients may require a higher dose to achieve the targeted trough levels.
Danish: Det bør bemærkes, at det hos sorte patienter kan være nødvendigt med en højere dosis for at opnå de målrettede dalkoncentrationer.
English: In current clinical practice, whole blood levels are monitored using immunoassay methods.
Danish: I nuværende klinisk praksis måles koncentrationer i fuldblod ved hjælp af immunassaymetoder.
English: In rats, tacrolimus caused toxic effects to the nervous system and the eyes.
Danish: Hos rotter forårsagede tacrolimus toksiske bivirkninger på nervesystem og øjne.
English: Certain combinations of tacrolimus with substances known to have nephrotoxic or neurotoxic effects may increase the risk of these effects (see section 4.5).
Danish: Visse kombinationer af tacrolimus og stoffer med kendte nefrotoksiske eller neurotoksiske bivirkninger kan øge risikoen for disse bivirkninger (se pkt.
English: Dose reduction may be necessary in patients with severe liver impairment in order to maintain the tacrolimus blood trough levels within the recommended target range.
Danish: Dosisreduktion kan være nødvendig hos patienter med svært nedsat leverfunktion for at holde bloddalkoncentrationerne for tacrolimus inden for det anbefalede målområde.
English: Most cases have been reversible, occurring with tacrolimus blood trough concentrations much higher than the recommended maximum levels.
Danish: De fleste tilfælde har været reversible og er forekommet hos patienter, der har haft langt højere bloddalkoncentrationer af tacrolimus end den anbefalede maksimale koncentration.