FrancophonIA/ELRC3.0 huggingface dataset:
English: During subsequent maintenance therapy, blood concentrations have generally been in the range of 5 - 15 nanogram/ml in liver, kidney and heart transplant recipients.
Danish: Efterfølgende har koncentrationerne i fuldblod generelt ligget på 5 - 15 nanogram/ml for lever-, nyre- og hjertetransplanterede patienter ved vedligeholdelsesbehandling.
English: In man, tacrolimus has been shown to be able to be absorbed throughout the gastrointestinal tract.
Danish: Det er påvist, at tacrolimus kan absorberes i hele mave-tarmkanalen hos mennesker.
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: Blood trough levels of tacrolimus should also be closely monitored when clinical signs of toxicity or acute rejection are observed, following conversion between Modigraf granules to Prograf capsules, 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 tacrolimuskoncentrationer i blod bør også monitoreres nøje i følgende tilfælde: ved kliniske tegn på toksicitet eller akut afstødning, efter skift fra Prografkapsler til Modigrafgranulat, 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: pancreatic pseudocyst, subileus Hepatobiliary disorders common:
Danish: pseudocyster i pancreas, subileus
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 nanogram/ml by Day 5 and 5 to 10 nanogram/ml after Month 6.
Danish: Den initiale orale per protokoldosis af tacrolimus var 0,2 mg/kg/dag med følgende dosisjustering for at opnå dalkoncentrationer på 8 - 15 nanogram/ml på 5. dagen og 5 - 10 nanogram/ml efter 6. måned.
English: Treatment of allograft rejection after heart transplantation therapy - adults and paediatric patients In adult patients converted to Modigraf, an initial oral dose of 0.15 mg/kg/day should be administered in 2 divided doses (e.g. morning and evening).
Danish: Afstødningsbehandling efter hjertetransplantationsterapi - voksne og pædiatriske patienter Til voksne patienter, som er blevet overført til Modigraf, bør den initiale orale dosis på 0,15 mg/kg/dag administreres som 2 separate doser (f.eks. morgen og aften).
English: Allergic and anaphylactoid reactions have been observed in patients receiving tacrolimus (see section 4.4).
Danish: Immunsystemet Allergiske og anafylaktoide reaktioner er observeret hos patienter, der fik tacrolimus (se pkt.
English: Patients should be converted to oral therapy as soon as clinically practicable.
Danish: Patienten skal overgå til oral behandling, så snart tilstanden tillader det.
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 nanogram/ml, and most recently allograft irradiation were considered to have contributed to improved results in this indication over time.
Danish: For eksempel findes i dag teknikker til tidlig diagnose af EpsteinBarr-virus (EBV)- og CMV-infektioner, knoglemarvsforøgelse, samtidig brug af interleukin-2 antagonisten daclizumab, lavere initiale doser af tacrolimus med dalkoncentrationer på 10 - 15 nanogram/ml og senest bestråling af allotransplantat.
English: anaemia, thrombocytopenia, leukopenia, red blood cell analyses abnormal, leukocytosis uncommon:
Danish: anæmi, trombocytopeni, leukopeni, unormale analyseresultater af røde blodlegemer, leukocytose
English: In rats and rabbits, tacrolimus caused embryofoetal toxicity at doses which demonstrated maternal toxicity (see section 5.3).
Danish: Tacrolimus medfører embryoføtal toksicitet hos rotter og kaniner ved doser som var toksiske for moderen (se pkt.
English: heart failures, ventricular arrhythmias and cardiac arrest, supraventricular arrhythmias, cardiomyopathies, ventricular hypertrophy, palpitations rare:
Danish: hjertesvigt, ventrikulære arytmier og hjertestop, supraventrikulære arytmier, kardiomyopati, ventrikulær hypertrofi, palpitationer
English: coagulopathies, pancytopenia, neutropenia, coagulation and bleeding analyses abnormal rare:
Danish: koagulationsforstyrrelser, pancytopeni, neutropeni, unormale koagulations- og blødningsanalyser
English: In adult and paediatric liver transplant patients, it averaged 11.7 hours and 12.4 hours, respectively, compared with 15.6 hours in adult kidney transplant recipients.
Danish: 11,7 timer og 12,4 timer og hos voksne nyretransplanterede fandt man en værdi på 15,6 timer.
English: Patients should be maintained on a single formulation of tacrolimus with the corresponding dosing regimen; alterations in formulation or regimen should only take place under the close supervision of a transplant specialist (see sections 4.4 and 4.8).
Danish: Patienter bør fastholdes på én lægemiddelform af tacrolimus med det tilsvarende dosisregime; ændringer i lægemiddelform eller regime bør kun ske under nøje supervision fra en transplantationsspecialist (se pkt.
English: Stevens Johnson syndrome Musculoskeletal and connective tissue disorders common:
Danish: Stevens-Johnsons syndrom Knogler, led, muskler og bindevæv Almindelig:
English: Psychiatric disorders very common:
Danish: Psykiske forstyrrelser Meget almindelig:
English: When substances with a potential for interaction (see section 4.5) - particularly strong inhibitors of CYP3A4 (such as telaprevir, boceprevir, ritonavir, ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or inducers of CYP3A4 (such as rifampicin, rifabutin) - are being combined with tacrolimus, tacrolimus blood levels should be monitored to adjust the tacrolimus dose as appropriate in order to maintain similar tacrolimus exposure.
Danish: 4.5) - især stærke CYP3A4-hæmmere (såsom telaprevir, boceprevir, ritonavir, ketoconazol, voriconazol, itraconazol, telithromycin eller clarithromycin) eller CYP3A4-inducere (såsom rifampicin, rifabutin) - kombineres med tacrolimus, bør tacrolimus' blodkoncentration overvåges, og om nødvendigt justeres dosis for at vedligeholde den systemiske eksponering for tacrolimus.
English: headache, tremor common:
Danish: hovedpine, tremor
English: For these reasons, the combined administration of ciclosporin and tacrolimus is not recommended and care should be taken when administering tacrolimus to patients who have previously received ciclosporin (see sections 4.2 and 4.4).
Danish: Af disse grunde kan det ikke anbefales at administrere ciclosporin sammen med tacrolimus, og man bør udvise forsigtighed ved administration af tacrolimus til patienter, der tidligere er blevet behandlet med ciclosporin (se pkt.
English: nephropathy, cystitis haemorrhagic Reproductive system and breast disorders uncommon:
Danish: nefropati, hæmaturi Det reproduktive system og mammae Ikke almindelig:
English: encephalopathy, central nervous system haemorrhages and cerebrovascular accidents, coma, speech and language abnormalities, paralysis and paresis, amnesia rare:
Danish: encefalopati, blødning i centralnervesystemet og hjerneblødning, koma, tale- og sprogforstyrrelser, paralyse og pareser, amnesi
English: CYP3A4 inhibitors potentially leading to increased tacrolimus blood levels Clinically the following substances have been shown to increase tacrolimus blood levels: Strong interactions have been observed with antifungal agents such as ketoconazole, fluconazole, itraconazole, voriconazole, and isavuconazole, the macrolide antibiotic erythromycin, HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), HCV protease inhibitors (e.g. telaprevir, boceprevir, and the combination of ombitasvir and paritaprevir with ritonavir, when used with and without dasabuvir), or the CMV antiviral letermovir, the pharmacokinetic enhancer cobicistat, and the tyrosine kinase inhibitors nilotinib and imatinib.
Danish: CYP3A4-hæmmere som potentielt kan øge tacrolimus' blodkoncentrationer Det er påvist, at de følgende midler øger tacrolimus' blodkoncentration: Der er set kraftige interaktioner med svampemidler som ketoconazol, fluconazol, itraconazol, voriconazol og isavuconazol, det macrolide antibiotikum erythromycin, HIV-protease-hæmmere (f.eks. ritonavir, nelfinavir, saquinavir), HCV-proteasehæmmere (f.eks. telaprevir, boceprevir og en kombination af ombitasvir og paritaprevir sammen med ritonavir, når det anvendes med og uden dasabuvir), eller det CMV antivirale letermovir, den farmakokinetiske forstærker cobicistat og tyrosinkinasehæmmerne nilotinib og imatinib.
English: Very rare side effects (may affect up to 1 in 10,000 people): - Muscular weakness - Abnormal heart scan - Liver failure - Painful urination with blood in the urine - Increase of fat tissue
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 behandlede): - Muskelsvaghed - Unormalt resultat af hjerteundersøgelse - Leversvigt - Smertefuld vandladning med blod i urinen - Øget fedtvæv
English: thrombotic thrombocytopenic purpura, hypoprothrombinaemia, thrombotic microangiopathy not known:
Danish: trombotisk trombocytopenisk purpura, hypoprotrombinæmi, trombotisk mikroangiopati
English: Similarly, for conversion of patients from Prograf capsules to Modigraf granules, the total daily Modigraf dose should preferably be equal to the total daily Prograf dose.
Danish: Tilsvarende skal den totale daglige Modigrafdosis helst være den samme som den totale daglige Prografdosis ved skift af patienter fra Prografkapsler til Modigrafgranulat.
English: dysmenorrhoea and uterine bleeding General disorders and administration site conditions common:
Danish: dysmenoré og uterin blødning Almene symptomer og reaktioner på administrationsstedet Almindelig:
English: Each sachet contains 473 mg lactose (as monohydrate).
Danish: Hvert brev indeholder 473 mg lactose (som monohydrat).
English: An initial oral dose of 0.30 mg/kg/day should be administered in 2 divided doses (e.g. morning and evening).
Danish: En begyndelsesdosis på 0,30 mg/kg/dag bør administreres i 2 separate doser (f.eks. morgen og aften).
English: cysts and polyps) Patients receiving immunosuppressive therapy are at increased risk of developing malignancies.
Danish: Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper) Patienter i immunsuppressiv behandling har en øget risiko for at få maligne lidelser.
English: How to take Modigraf
Danish: Sådan skal De tage Modigraf
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 4.5).
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: Each sachet contains 94.7 mg lactose (as monohydrate).
Danish: Hvert brev indeholder 94,7 mg lactose (som monohydrat).
English: As the pharmacokinetics of tacrolimus are unaffected by renal function (see section 5.2), no dose adjustment is required.
Danish: Da farmakokinetikken for tacrolimus er uafhængig af nyrefunktionen (se pkt.
English: acute and chronic pancreatitis, ileus paralytic, gastrooesophageal reflux disease, impaired gastric emptying rare:
Danish: akut og kronisk pancreatitis, paralytisk ileus, gastroøsofagal refluks, nedsat tømning af mavesækken
English: Modigraf 0.2 mg granules for oral suspension Modigraf 1 mg granules for oral suspension
Danish: Modigraf 0,2 mg granulat til oral suspension Modigraf 1 mg granulat til oral suspension
English: Vascular disorders very common:
Danish: Vaskulære sygdomme Meget almindelig:
English: venous thrombosis deep limb, shock, infarction Respiratory, thoracic and mediastinal disorders common:
Danish: dyb venetrombose, shock, infarkt Luftveje, thorax og mediastinum Almindelig:
English: Package leaflet: Information for the user Modigraf 0.2 mg, granules for oral suspension Modigraf 1 mg, granules for oral suspension
Danish: Indlægsseddel: Information til brugeren Modigraf 0,2 mg, granulat til oral suspension Modigraf 1 mg, granulat til oral suspension tacrolimus
English: In patients without antibody induction, if tacrolimus therapy is initiated intravenously, the recommended starting dose is 0.03 - 0.05 mg/kg/day (with Prograf 5 mg/ml concentrate for solution for infusion) as a continuous 24-hour infusion targeted to achieve tacrolimus whole blood concentrations of 15 - 25 nanogram/ml.
Danish: Hvis tacrolimusbehandling er initieret intravenøst hos patienter uden antistofinduktion er den anbefalede startdosis 0,03 - 0,05 mg/kg/dag (med Prograf 5 mg/ml koncentrat til infusionsvæske, opløsning) som en kontinuert 24-timers infusion, idet man forsøger at opnå tacrolimusfuldblodskoncentrationer på 15 - 25 nanogram/ml.
English: diabetes mellitus, hyperglycaemic conditions, hyperkalaemia common:
Danish: diabetes mellitus, hyperglykæmi, hyperkaliæmi
English: Modigraf blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Modigraf, which may require interruption, an increase or a decrease in Modigraf dose.
Danish: Indholdet af Modigraf i blodet kan påvirkes af anden medicin, og Modigraf kan påvirke indholdet af anden medicin i blodet.
English: Hypersensitivity to tacrolimus or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for tacrolimus eller over for et eller flere af hjælpestofferne anført i pkt.
English: Very common side effects (may affect more than 1 in 10 people): - Increased blood sugar, diabetes mellitus, increased potassium in the blood - Difficulty in sleeping - Trembling, headache - Increased blood pressure - Liver function tests abnormal - Diarrhoea, nausea - Kidney problems
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 behandlede): - Forhøjet blodsukker, sukkersyge, øget kaliumindhold i blodet - Søvnløshed - Rysten, hovedpine - Forhøjet blodtryk - Unormale leverfunktionstests - Diarré, kvalme - Nyreproblemer
English: eye disorders, vision blurred, photophobia uncommon:
Danish: øjenlidelser, sløret syn, fotofobi
English: Modigraf is a granular formulation of tacrolimus, for twice-a-day administration.
Danish: Modigraf er en granulatformulering af tacrolimus, som skal tages to gange dagligt.
English: Tacrolimus is widely metabolised in the liver, primarily by the cytochrome P450-3A4.
Danish: Tacrolimus metaboliseres i udstrakt grad i leveren, primært af CYP-3A4.
English: Croscarmellose sodium (E468)
Danish: Lactosemonohydrat Hypromellose (E464) Croscarmellosenatrium (E468).
English: High potassium intake or potassium-sparing diuretics should be avoided (see section 4.5).
Danish: Undgå høj kaliumindtagelse og kaliumbesparende diuretika (se pkt.
English: The steady-state volume of distribution based on plasma concentrations is approximately 1300 l (healthy subjects).
Danish: På basis af måling af plasmakoncentrationer hos raske forsøgspersoner, fandt man et gennemsnitligt distributionsvolumen ved steady state på ca. 1300 l. Det tilsvarende tal baseret på fuldblod var 47,6 l.
English: Careful and frequent monitoring of tacrolimus trough levels is recommended in the first 2 weeks post-transplant to ensure adequate exposure to the active substance in the immediate post-transplant period.
Danish: For at sikre en fyldestgørende eksponering i begyndelsen af den post-transplanterede periode anbefales det at overvåge tacrolimus' dalværdier omhyggeligt og hyppigt de første 2 uger efter transplantationen.
English: Prophylaxis of heart transplant rejection
Danish: Profylakse mod hjertetransplantatafstødning
English: This medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients.
Danish: Kun læger med erfaring i immunsuppressiv behandling og behandling af organtransplanterede patienter bør ordinere dette lægemiddel og initiere ændringer i den immunsuppressive behandling.
English: fever, nausea or vomiting - if you have an alteration of the electrical activity of your heart called “QT prolongation”.
Danish: - hvis De har en ændring i hjerterytmen, som kaldes ”QT-forlængelse”.
English: Eye disorders common:
Danish: Øjne Almindelig:
English: After preparation, the suspension should be taken immediately.
Danish: Suspensionen bør indtages umiddelbart efter fremstillingen.
English: inflammation of the throat, cough, flu-like symptoms - Stomach problems such as inflammation or ulcer causing abdominal pain or diarrhoea, bleeding in the stomach, inflammation or ulcer in the mouth, collection of fluid in the belly, vomiting,
Danish: influenzalignende symptomer - Maveproblemer såsom betændelse eller mavesår som giver mavesmerter eller diarré, maveblødning,
English: Rare side effects (may affect up to 1 in 1,000 people): - Small bleedings in your skin due to blood clots - Increased muscle stiffness - Blindness, deafness - Collection of fluid around the heart - Acute breathlessness - Cyst formation in your pancreas - Problems with blood flow in the liver - Serious illness with blistering of skin, mouth, eyes and genitals; increased hairiness - Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1000 behandlede): - Små blødninger i huden - Øget muskelstivhed - Blindhed, døvhed - Væskeansamling omkring hjertet - Akut åndenød - Cystedannelse på bugspytkirtlen - Problemer med blodcirkulation i leveren - Alvorlig sygdom med blærer i huden, munden, øjnene og kønsorganerne, øget behåring - Tørst, øget tendens til at falde, trykken for brystet, nedsat bevægelighed, sår
English: metabolic acidoses, other electrolyte abnormalities, hyponatraemia, fluid overload, hyperuricaemia, hypomagnesaemia, hypokalaemia, hypocalcaemia, appetite decreased, hypercholesterolaemia, hyperlipidaemia, hypertriglyceridaemia, hypophosphataemia uncommon:
Danish: hypervolæmi, hyperurikæmi, hypomagnesæmi, hypokaliæmi, hypokalcæmi, nedsat appetit, hyperkolesterolæmi, hyperlipidæmi, hypertriglyceridæmi, hypofosfatæmi
English: amylase increased, ECG investigations abnormal, heart rate and pulse investigations abnormal, weight decreased, blood lactate dehydrogenase increased very rare:
Danish: forhøjet amylase, EKG-forandringer, forandringer i hjerterytme og puls, vægttab, forhøjet blodlactatdehydrogenase
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.025 mg/kg/day and oral tacrolimus was administered at a dose of 0.15 mg/kg/day with subsequent dose adjustments to target trough levels of 10 to 20 nanogram/ml.
Danish: Tacrolimusbehandling begyndte som kontinuerlig intravenøs infusion med doser på 0,025 mg/kg/dag, og oral tacrolimus blev administreret i doser på 0,15 mg/kg/dag med følgende dosisjustering for at nå dalkoncentrationer på 10-20 nanogram/ml.
English: Thereafter the cup is rinsed once with the same quantity of water and the rinsings consumed by the patient.
Danish: Derefter skylles koppen en gang med den samme mængde vand, som patienten efterfølgende drikker.
English: Each sachet contains 0.2 mg tacrolimus (as monohydrate).
Danish: Hvert brev indeholder 0,2 mg tacrolimus (som monohydrat).
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, ud fra Deres vægt, beregne den rigtige startdosis for at undgå afstødning af det transplanterede organ.
English: The effect of a high-carbohydrate meal is less pronounced.
Danish: Effekten er størst efter et meget fedtholdigt måltid, hvorimod effekten er mindre udtalt efter et kulhydratrigt måltid.
English: influenza like illness, feeling jittery, feeling abnormal, multi-organ failure, chest pressure sensation, temperature intolerance rare:
Danish: influenzalignende symptomer, nervøsitet, fremmedfølelse, multiorgansvigt, trykken for brystet, temperaturintolerans
English: hallucination, mental disorders - Fits, disturbances in consciousness, tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders - Blurred vision, increased sensitivity to light, eye disorders - Ringing sound in your ears - Reduced blood flow in the heart vessels, faster heartbeat - Bleeding, partial or complete blocking of blood vessels, reduced blood pressure - Shortness in breath, changes in the lung tissue, collection of liquid around the lung,
Danish: forstyrret sindstilstand - Anfald, bevidsthedsforstyrrelser, prikken og følelsesløshed (nogle gange smertefuld) i hænder og fødder, svimmelhed, nedsat skriveevne, forstyrrelser i nervesystemet - Sløret syn, øget lysfølsomhed, problemer med øjnene - Ringen for ørene - Nedsat blodgennemstrømning i hjertets blodkar, øget puls - Blødning, delvis eller fuldstændig blokering af blodkar, nedsat blodtryk - Stakåndethed, forandring i lungevæv, væskeansamling omkring lungen, betændelse i svælget, hoste,
English: parenchymal lung disorders, dyspnoea, pleural effusion, cough, pharyngitis, nasal congestion and inflammations uncommon:
Danish: lidelse i lungeparenkymet, dyspnø, pleura-effusion, hoste, pharyngitis, tilstopning og inflammation i næsen
English: Tacrolimus was started as continuous intravenous infusion at a dose of 0.05 mg/kg/day and oral tacrolimus was administered at a dose of 0.1 to 0.3 mg/kg/day with subsequent dose adjustments to target trough levels of 12 to 15 nanogram/ml.
Danish: Tacrolimus startede som kontinuerlig intravenøs infusion med doser på 0,05 mg/kg/dag, hvorefter oral tacrolimus blev administreret i doser på 0,1 - 0,3 mg/kg/dag med følgende dosisjustering for at nå dalkoncentrationer på 12 - 15 nanogram/ml.
English: Modigraf 1 mg granules for oral suspension Each sachet contains 1 mg tacrolimus (as monohydrate).
Danish: Modigraf 1 mg granulat til oral suspension Hvert brev indeholder 1 mg tacrolimus (som monohydrat).
English: EBV-Viral Capsid Antigen (VCA)-negative patients have been reported to have an increased risk of developing lymphoproliferative disorders.
Danish: Der er rapporteret om øget risiko for udvikling af lymfoproliferative lidelser hos EBV-Viral Capsid Antigen (VCA)-negative patienter.
English: Tacrolimus affected fertility in male rats (see section 5.3).
Danish: Tacrolimus påvirkede fertiliteten hos hanrotter (se pkt.
English: hepatic failure Skin and subcutaneous tissue disorders common:
Danish: Hud og subkutane væv Almindelig:
English: Modigraf 0.2 mg granules for oral suspension Each sachet contains 0.2 mg tacrolimus (as monohydrate).
Danish: Modigraf 0,2 mg granulat til oral suspension Hvert brev indeholder 0,2 mg tacrolimus (som monohydrat).