FrancophonIA/ELRC3.0 huggingface dataset:
English: Maintenance doses of corticosteroids have been shown to reduce tacrolimus blood levels.
Danish: Vedligeholdelsesdoser af kortikosteroider reducerer tacrolimusblodkoncentrationen.
English: Frequent trough level monitoring in the initial 2 weeks post transplantation is recommended, followed by periodic monitoring during maintenance therapy.
Danish: Det anbefales at overvåge koncentrations-niveauerne hyppigt de 2 første uger efter transplantation og at følge op med periodisk overvågning under vedligeholdelsesbehandlingen.
English: Blood trough levels should be monitored at least twice weekly during the early post-transplant period and then periodically during maintenance therapy.
Danish: Dalværdierne for tacrolimus-koncentrationerne i blodet bør overvåges mindst to gange ugentlig under den tidlige post-operative fase og derefter periodisk under vedligeholdelsesbehandlingen.
English: Lansoprazole and ciclosporin may potentially inhibit CYP3A4-mediated metabolism of tacrolimus and thereby increase tacrolimus whole blood concentrations.
Danish: Lansoprazol og ciclosporin kan potentielt hæmme tacrolimus' CYP3A4-medierede metabolisme og hermed øge blodkoncentrationen af tacrolimus i fuldblod.
English: Other medicines and Modigraf
Danish: Brug af anden medicin sammen med Modigraf
English: In comparison to Caucasians, black patients may require higher tacrolimus doses to achieve similar trough levels.
Danish: Sammenlignet med kaukasider, kræves en højere dosis af tacrolimus til sorte patienter for at opretholde samme niveau.
English: The use of live attenuated vaccines should be avoided (see section 4.4).
Danish: Brug af levende, afsvækkede vacciner skal undgås (se pkt.
English: In case of in utero exposure, monitoring of the newborn for the potential adverse events of tacrolimus is recommended (in particular effects on the kidneys).There is a risk for premature delivery (<37 week) (incidence of 66 of 123 births, i.e. 53.7%; however, data showed that the majority of the newborns had normal birth weight for their gestational age) as well as for hyperkalaemia in the newborn (incidence 8 of 111 neonates, i.e. 7.2%) which, however normalises spontaneously.
Danish: Der er risiko for præmatur fødsel (<37 uger) (forekom ved 66 ud af 123 fødsler, dvs. 53,7 %; dog viste data, at størstedelen af de nyfødte havde normal fødselsvægt for deres gestationsalder) såvel som hyperkaliæmi hos den nyfødte (forekomst hos 8 ud af 111 nyfødte.
English: As tacrolimus is a substance with low clearance, it may take several days after adjustments to the Modigraf dose regimen before the targeted steady state is achieved (see section 5.2).
Danish: Da tacrolimus er et lægemiddelstof med lav clearance, kan det tage adskillige dage efter en justering af dosisregimet for Modigraf, før den ønskede steady state er opnået (se pkt.
English: CYP3A4 inducers potentially leading to decreased tacrolimus blood levels 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: CYP3A4-inducere som potentielt kan nedsætte tacrolimus' blodkoncentrationer Det er påvist klinisk, at de følgende lægemidler nedsætter tacrolimus-blodkoncentrationen: Der er set kraftige interaktioner med rifampicin, phenytoin og perikon (Hypericum perforatum), som kan kræve øget dosering af tacrolimus hos næsten alle patienter.
English: Certain combinations of tacrolimus with drugs known to have nephrotoxic or neurotoxic effects may increase the risks of these effects (see section 4.5).
Danish: Samtidig brug af tacrolimus og lægemidler med nefrotoksisk eller neurotoksisk effekt kan øge risikoen for disse bivirkninger (se pkt.
English: Possible interactions with other medicinal products known to have high affinity for plasma proteins should be considered (e.g., NSAIDs, oral anticoagulants, or oral antidiabetics).
Danish: Man bør derfor tage højde for risikoen for interaktioner med andre lægemidler, der har høj affinitet for plasmaproteiner (f.eks. NSAID, orale antikoagulantia og orale antidiabetika).
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 såsom lav hæmatokrit og lavt serumprotein, der giver en øget ubunden fraktion af tacrolimus, samt kortikosteroidinduceret øget metabolisme, betragtes som hovedårsagerne til den højere clearance, man finder hos transplanterede patienter.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET FOIL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER BREVFOLIE
English: Modigraf granules for oral suspension are white granules supplied in sachets.
Danish: Modigraf granulat til oral suspension er hvidt granulat i breve.
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 Modigraf.
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 Modigraf.
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 concentrations and alanine aminotransferase levels.
Danish: Der er rapporteret flere tilfælde af utilsigtet overdosering med tacrolimus; symptomerne inkluderer tremor, hovedpine, kvalme og opkastninger, infektioner, urticaria, letargi og forhøjet blodurinstof, serumkreatininkoncentrationer og alanin-aminotransferase niveauer.
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, norethisterone, quinidine, tamoxifen, troleandomycin.
Danish: Det er påvist in vitro, at de følgende midler er potentielle hæmmere af tacrolimus' metabolisme: Bromocriptin, kortison, dapson, ergotamin, gestoden, lidocain, mephenytoin, miconazol, midazolam, nilvadipin, norethisteron, quinidin, tamoxifen, troleandomycin.
English: Treatment of allograft rejection after transplantation of other allografts The dose recommendations for lung, pancreas and intestinal transplantation are based on limited prospective clinical trial data with the Prograf formulation.
Danish: Dosisanbefalingerne for lunge-, pancreas- og intestinaltransplantation er baseret på begrænsede prospektive kliniske data med Prografformuleringen.
English: Modigraf should not be switched with the prolonged-release capsules (Advagraf) as a clinically relevant difference in bioavailability between the two formulations cannot be excluded.
Danish: Modigraf bør ikke substitueres med depotkapsler (Advagraf), da klinisk relevant forskel i biotilgængelighed mellem de to lægemiddelformer ikke kan udelukkes.
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 ofte vanskeligt at fastslå bivirkningsprofilen ved immunsuppressiv behandling på grund af den underliggende lidelse og samtidig brug af flere andre lægemidler.
English: Another randomised study included 66 patients on tacrolimus versus 67 patients on ciclosporin.
Danish: En anden randomiseret undersøgelse omfattede 66 patienter behandlet med tacrolimus og 67 patienter behandlet med ciclosporin.
English: Other interactions which have led 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, sulfamethoxazole+trimethoprim, NSAIDs, ganciclovir or aciclovir).
Danish: Andre interaktioner som har ført til klinisk skadelig effekt Samtidig brug af tacrolimus og lægemidler med kendt nefrotoksisk eller neurotoksisk effekt kan øge toksiciteten (f.eks. aminoglycosider, gyrase-hæmmere, vancomycin, sulfamethoxazol+trimethoprim, NSAID, gangliclovir og aciclovir).
English: When treating rejection, these same doses may be used.
Danish: Samme dosis kan anvendes til behandling af afstødning.
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 neoplasmer herunder EBV-associerede lymfoproliferative lidelser og maligne tilstande i huden er blevet rapporteret i forbindelse med behandling med tacrolimus.
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-hæmmer vil samtidig brug af tacrolimus påvirke metabolismen af lægemidler, der metaboliseres via CYP3A4.
English: Post-transplant improvement 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: It is recommended that the oral daily dose of Modigraf be administered in 2 divided doses (e.g. morning and evening).
Danish: Det anbefales, at den daglige orale dosis af Modigraf administreres som 2 separate doser (f.eks. morgen og aften).
English: Modigraf 0.2 mg granules for oral suspension EU/1/09/523/001
Danish: Modigraf 0,2 mg granulat til oral suspension EU/1/09/523/001
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 ekstrakter af Schisandra sphenanthera.
English: In paediatric liver transplant patients the mean oral bioavailability of tacrolimus (investigated with the Modigraf granules) is 26%± 23% (individual range in paediatric liver transplant patients 4 - 80%).
Danish: Hos pædiatriske levertransplanterede patienter er den gennemsnitlige orale biotilgængelighed for tacrolimus (undersøgt med Modigrafgranulat) 26 % ± 23 % (individuelt interval hos pædiatriske levertransplanterede patienter 4-80 %).
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 hæmmer eller inducerer CYP3A4, kan påvirke tacrolimus' metabolisme og derved nedsætte eller øge tacrolimusblodkoncentrationerne.
English: As tacrolimus treatment may be associated with hyperkalaemia, or may increase pre-existing hyperkalaemia, high potassium intake, or potassium-sparing diuretics (e.g. amiloride, triamterene, or spironolactone) should be avoided (see section 4.4).
Danish: Da tacrolimus kan give hyperkaliæmi eller forstærke en allerede eksisterende hyperkaliæmi, bør høj kaliumindtagelse eller kaliumbesparende diuretika (f.eks. amilorid, triameteren eller spironolacton) undgås (se pkt.
English: Each sachet contains less than 1 mmol sodium (23 mg).
Danish: Hvert brev indeholder mindre end 1 mmol (23 mg) natrium.
English: confusion and disorientation, depression, anxiety symptoms, hallucination, mental disorders, depressed mood, mood disorders and disturbances, nightmare uncommon:
Danish: konfusion og desorientering, depression, angstsymptomer, hallucinationer, mentale lidelser, nedtrykthed, følelsesmæssig labilitet, mareridt
English: The suspension should be administered immediately after preparation.
Danish: Suspensionen bør administreres umiddelbart efter fremstillingen.
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 obliteranssyndromet (2,86 % versus 8,57 %).
English: In a study of stable renal transplant patients who were administered tacrolimus immediately after a standard continental breakfast the effect on oral bioavailability was less pronounced.
Danish: I en undersøgelse med stabile nyretransplanterede patienter var virkningen på den orale biotilgængelighed mindre udtalt ved indgift af Prograf umiddelbart efter en normal kontinental morgenmad.
English: Administration should commence approximately 12 hours after the completion of surgery.
Danish: Administrationen bør indledes inden for 12 timer efter afslutningen af indgrebet.
English: Modigraf granules contain lactose.
Danish: Modigrafgranulat indeholder lactose.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Modigraf nøjagtigt efter lægens anvisning.
English: In clinical practice, whole blood trough levels have generally been in the range 5 - 20 nanogram/ml in liver transplant recipients and 10 - 20 nanogram/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 i området 5 - 20 nanogram/ml for levertransplanterede og i området 10 - 20 nanogram/ml for nyre- og hjertetransplanterede i den tidlige post-operative periode.
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 QT-forlængelse, eller patienter, som samtidig får behandling med lægemidler, som er kendt for at forlænge QT-intervallet, inducere elektrolytforstyrrelser eller øge tacrolimuseksponeringen (se pkt.
English: dehydration, hypoglycaemia, hypoproteinaemia, hyperphosphataemia
Danish: dehydrering, hypoglykæmi, hypoproteinæmi, hyperfosfatæmi
English: Granules are added to the water and stirred.
Danish: Granulatet hældes i vandet og omrøres.
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 post-operative 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: Prograf has been used in lung-transplanted patients at an initial oral dose of 0.10 - 0.15 mg/kg/day, in pancreas-transplanted patients at an initial oral dose of 0.2 mg/kg/day and in intestinal transplantation at an initial oral dose of 0.3 mg/kg/day.
Danish: Prograf er blevet anvendt hos lungetransplanterede patienter med en initial oral dosis på 0,10 - 0,15 mg/kg/dag, i pancreastransplanterede patienter med en initial oral dosis på 0,2 mg/kg/dag og ved intestinaltransplantation med en initial oral dosis på 0,3 mg/kg/dag.
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 bivirkninger på selve graviditeten eller dens forløb ved behandling med tacrolimus.
English: In paediatric liver and kidney transplant patients, values for total body clearance of 2.3 ± 1.2 ml/min/kg and 2.1 ± 0.6 ml/min/kg, respectively, have been observed.
Danish: Hos pædiatriske lever- og nyretransplanterede patienter er værdier på henholdsvis 2,3 ± 1,2 ml/min/kg og 2,1 ± 0,6 ml/min/kg observeret.
English: Modigraf contains lactose (milk sugar).
Danish: Modigraf indeholder lactose (mælkesukker).
English: In isolated patients with very high plasma levels, haemofiltration or -diafiltration have been effective in reducing toxic concentrations.
Danish: Hos nogle få patienter med meget høje plasmakoncentrationer har man effektivt kunnet reducere de toksiske koncentrationer med hæmofiltration eller hæmodiafiltration.
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), non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) used for fever, inflammation and pain, anticoagulants (blood thinners), or oral medicines for diabetes, while you take Modigraf.
Danish: Deres læge skal også vide, om De tager kaliumtilskud eller vanddrivende medicin, som bruges ved hjertesvigt, hypertension og nyresygdom (f.eks. amilorid, triamteren eller spironolacton), non-steroide antiinflammatoriske midler (NSAID, f.eks. ibuprofen), som bruges ved feber, betændelsestilstande og smerter, blodfortyndende medicin (antikoagulantia) eller oral medicin mod diabetes (sukkersyge), mens De tager Modigraf.
English: It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to tacrolimus-based dual therapy.
Danish: Det er i visse tilfælde muligt at seponere anden samtidig immunsuppressiv behandling, som resulterer i tacrolimusbaseret dualterapi.
English: Mean oral bioavailability of tacrolimus (investigated with the Prograf capsules formulation) is in the range of 20 - 25% (individual range in adult patients 6 - 43%, in paediatric kidney transplant patients 3 - 77%).
Danish: Den orale gennemsnitlige biotilgængelighed af tacrolimus (undersøgt vha. Prografkapsler) ligger mellem 20-25 % (individuelt hos voksne 6-43 %, hos pædiatriske nyretransplanterede patienter 3-77 %).
English: Herbal preparations containing St. John's Wort (Hypericum perforatum) or other herbal preparations should be avoided when taking Modigraf 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: Naturmedicin, der indeholder perikon (Hypericum perforatum), eller anden naturmedicin bør undgås ved behandling med Modigraf 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 toksicitet af tacrolimus (se pkt.
English: Dosing should primarily be based on clinical assessments of rejection and tolerability in each individual patient aided by whole blood tacrolimus trough level monitoring.
Danish: Dosering skal baseres primært på kliniske vurderinger af afstødning og tolerans hos den enkelte patient og ved overvågning af tacrolimusniveauet i blod.
English: Do not use this medicine after the expiry date which is stated on the carton and sachet after EXP.
Danish: Brug ikke Modigraf efter den udløbsdato, der står på pakningen og brevet efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Prophylaxis of transplant rejection in adult and paediatric, kidney, liver or heart allograft recipients.
Danish: Profylakse af transplantatafstødning hos voksne og pædiatriske nyre-, lever- eller hjertetransplanterede patienter (allograft transplantation).
English: As is well known for other potent immunosuppressive agents, patients receiving tacrolimus are frequently at increased risk for infections (viral, bacterial, fungal, protozoal).
Danish: Som det er tilfældet ved behandling med andre potente immunsuppressive midler, øger behandlingen med tacrolimus patienternes modtagelighed for infektioner (virus, bakterier, svampe, protozoer).
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 CYP3A4metaboliseringen eller på anden vis påvirke tacrolimus' blodkoncentration, og at afbryde eller justere tacrolimusdosis tilsvarende for at vedligeholde en konstant eksponering (se pkt.
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 bindes kraftigt til erytrocytterne, således at fuldblod/plasmakvotienten er ca. 20:1.
English: - The other ingredients are: lactose monohydrate, hypromellose (E464) and croscarmellose sodium (E468).
Danish: Lactosemonohydrat, hypromellose (E464) og croscarmellosenatrium (E468).
English: hirsutism Metabolism and nutrition disorders very common:
Danish: Metabolisme og ernæring Meget almindelig:
English: It is possible in some cases to withdraw concomitant immunosuppressive therapy, leading to tacrolimus monotherapy.
Danish: Det er i visse tilfælde muligt at seponere anden samtidig immunsuppressiv behandling, som resulterer i tacrolimusbaseret monoterapi.
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 overeller undereksponering for tacrolimus.
English: As tacrolimus is a substance with low clearance, it may take several days after adjustments to the Modigraf dose regimen before steady state is achieved (see below under “Therapeutic drug monitoring” and section 5.2).
Danish: Da tacrolimus er et stof med lav clearance, kan det tage flere dage, inden steady state opnås efter justering af Modigrafdosis (se nedenfor under ”Terapeutisk lægemiddelovervågning” og pkt.
English: Patients should be maintained on a single formulation of tacrolimus with the corresponding daily dosing regimen; alterations in formulations 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 lægemiddelformer eller regime bør kun ske under nøje supervision fra en transplantationsspecialist (se pkt.