FrancophonIA/ELRC3.0 huggingface dataset:
English: The kidneys and the pancreas were the primary organs affected in toxicity studies performed in rats and baboons.
Danish: Nyrer og pancreas var de primære organer, der blev påvirket i toksicitetsundersøgelser på rotter og bavianer.
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 undersøgelser har indikeret, at en stigning i blodniveauet primært skyldes den øgede, orale biotilgængelighed af tacrolimus grundet hæmning af gastrointestinal metabolisme.
English: In practice, tacrolimus-based therapy has been initiated 12 - 24 hours after discontinuation of ciclosporin.
Danish: I praksis kan behandling med tacrolimus starte 12 - 24 timer efter seponering af ciclosporinbehandlingen.
English: Do not use cups or spoons that are made of PVC (polyvinylchloride) to take Modigraf because the active substance in Modigraf may stick to PVC.
Danish: Tag ikke Modigraf med kopper eller skeer, som er lavet af PVC (polyvinylchlorid), da det virksomme stof i Modigraf kan klæbe til PVC.
English: A strong correlation exists between AUC and whole blood trough levels at steady-state for Modigraf.
Danish: Der er god korrelation mellem AUC og dalværdierne i fuldblod ved steady state for Modigraf.
English: Bile flow does not influence the absorption of tacrolimus and therefore treatment with Modigraf granules may commence orally.
Danish: Galdeflow påvirker ikke absorptionen af tacrolimus, og derfor kan behandling med Modigrafgranulat påbegyndes oralt.
English: There are no safety data available on the use of Modigraf granules following a temporary switch from Prograf or Advagraf in critically ill patients.
Danish: Der er ingen tilgængelige sikkerhedsdata for brug af Modigrafgranulat efter midlertidigt skift fra Prograf eller Advagraf hos kritisk syge patienter.
English: Clinically significant interactions have also been observed with phenobarbital.
Danish: Der er også rapporteret klinisk relevante interaktioner med phenobarbital.
English: Dose adjustments should be made to ensure that similar systemic exposure is maintained.
Danish: Dosis bør justeres for at sikre, at den systemiske eksponering opretholdes.
English: In rats, tacrolimus caused toxic effects to the nervous system and the eyes.
Danish: Hos rotter forårsagede tacrolimus toksiske virkninger på nervesystemet og øjnene.
English: The combined administration of ciclosporin and tacrolimus is not recommended.
Danish: Samtidig administration af ciclosporin og tacrolimus kan ikke anbefales.
English: Animal data have shown that tacrolimus could potentially decrease the clearance and increase the half-life of pentobarbital and phenazone.
Danish: Data fra dyreundersøgelser har vist, at tacrolimus kunne nedsætte clearance og forøge halveringstiden af pentobarbital og phenazon.
English: In that case, an initial oral tacrolimus dose of 2 to 4 mg per day was used in combination with mycophenolate mofetil and corticosteroids or in combination with sirolimus and corticosteroids.
Danish: I dette tilfælde gives en initial oral tacrolimusdosis på 2 - 4 mg/dag sammen med mycophenolatmofetil og kortikosteroider eller sammen med sirolimus og kortikosteroider.
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with tacrolimus.
Danish: Tilfælde af Pure Red Cell Aplasia (PRCA) er blevet indberettet for patienter i behandling med tacrolimus.
English: 2 ml of water (at room temperature) should be used per 1 mg tacrolimus to produce a suspension (up to a maximum of 50 ml, depending on body weight) in a cup.
Danish: Der bør anvendes 2 ml vand (stuetemperatur) per 1 mg tacrolimus til at lave en suspension (maksimalt 50 ml, afhængig af legemsvægt) i en kop.
English: Administration should commence within 5 days after the completion of surgery as soon as the patient's clinical condition is stabilised.
Danish: Administrationen bør begynde inden 5 dage efter operationen og så snart patienten er stabil.
English: - If you are allergic to tacrolimus or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis De er allergisk over for tacrolimus eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER ANDET
English: The syndrome may respond to tacrolimus dose reduction.
Danish: Syndromet kan reagere på reduktion af tacrolimusdosis.
English: Materials containing polyvinyl chloride (PVC) should not be used (see section 6.2).
Danish: Materialer som indeholder polyvinylchlorid (PVC) bør ikke anvendes (se pkt.
English: Reversible cardiotoxic effects were observed in rabbits following intravenous administration of tacrolimus.
Danish: Der blev observeret reversible kardiotoksiske virkninger hos kaniner som følge af intravenøs administration af tacrolimus.
English: Gastrointestinal disorders
Danish: Gastrointestinale tilstande
English: The relationship between tacrolimus trough levels (C12) and systemic exposure (AUC0-12) is similar between the 2 formulations Modigraf granules and Prograf capsules.
Danish: Forholdet mellem tacrolimusniveauerne (C12) og systematisk eksponering (AUC0-12) er sammenligneligt for de 2 formuleringer Modigrafgranulat og Prografkapsler.
English: Pack size: carton box containing 50 sachets.
Danish: Pakningsstørrelse: Æske indeholdende 50 breve.
English: Dose reduction may be necessary in patients with severe liver impairment in order to maintain the blood trough levels within the recommended target range.
Danish: Det kan være nødvendigt at reducere dosis hos patienter med kraftigt nedsat leverfunktion for at holde blodkoncentrationerne inden for de anbefalede grænser.
English: Tacrolimus trough levels should be measured prior to conversion and within 1 week after conversion.
Danish: Dalværdierne for tacrolimus bør måles før skiftet og inden for en uge efter skiftet.
English: Other interactions potentially leading to increased tacrolimus blood levels Tacrolimus is extensively bound to plasma proteins.
Danish: Andre interaktioner som potentielt kan øge tacrolimus' blodkoncentrationer Tacrolimus bindes kraftigt til plasmaproteiner.
English: Ventricular hypertrophy or hypertrophy of the septum, reported as cardiomyopathies, have been observed on rare occasions.
Danish: Ventrikulær hypertrofi eller hypertrofi af septum, rapporteret som kardiomyopati, er blevet observeret hos patienter i enkelte tilfælde.
English: Following the initiation of your treatment with Modigraf, frequent blood tests will be taken by your doctor to define the correct dose and to adjust the dose from time to time.
Danish: Når behandlingen med Modigraf er påbegyndt, vil Deres læge ofte tage blodprøver for at bestemme den korrekte dosis og for løbende at justere dosis.
English: As an aid to optimise dosing, several immunoassays are available for determining tacrolimus concentrations in whole blood.
Danish: Som en hjælp til at optimere doseringen findes der adskillige immunoassays til bestemmelse af koncentrationer af tacrolimus i fuldblod.
English: If PRES is diagnosed, adequate blood pressure and seizure control and immediate discontinuation of systemic tacrolimus is advised.
Danish: Hvis PRES diagnostiseres, tilrådes det, at der udføres passende blodtryks- og anfaldskontrol, samt at systemisk tacrolimus omgående afbrydes.
English: Data from clinical studies suggests that the majority of patients can be successfully managed if tacrolimus blood trough levels are maintained below 20 nanogram/ml.
Danish: Data fra kliniske undersøgelser antyder, at behandlingen forløber godt hos de fleste patienter, hvis tacrolimus' blodkoncentrationer holdes under 20 nanogram/ml.
English: You may also be given Modigraf for an ongoing rejection of your transplanted liver, kidney, heart or other organ or if any previous treatment you were taking was unable to control this immune response after your transplantation.
Danish: De kan også få ordineret Modigraf ved en igangværende afstødning af det transplanterede organ (lever, nyre, hjerte eller andet), eller hvis Deres tidligere behandling ikke kunne kontrollere immunreaktionen efter transplantationen.
English: Effect on hepatic clearance is less pronounced.
Danish: Effekten på leverclearance er mindre tydelig.
English: From time to time, your doctor may need to do blood, urine, heart, eye tests, to set the right dose of Modigraf.
Danish: Fra tid til anden kan det være nødvendigt for lægen at tage blod- eller urinprøver eller undersøge Deres hjerte eller øjne for at bestemme den rette Modigrafdosis.
English: Modigraf contains the active substance tacrolimus.
Danish: Modigraf indeholder det aktive stof tacrolimus.
English: - If you are allergic to sirolimus (another substance used to prevent rejection of your transplanted organ) or to any macrolide antibiotic (e.g. erythromycin, clarithromycin, josamycin).
Danish: - hvis De er allergisk over for sirolimus (et andet lægemiddelstof, som bruges til at forebygge afstødning af det transplanterede organ) eller over for makrolidantibiotika (f.eks. erythomycin, clarithromycin, josamycin).
English: Modigraf can be used with antibody induction (allowing for delayed start of tacrolimus therapy) or alternatively in clinically stable patients without antibody induction.
Danish: Modigraf kan anvendes med antistofinduktion (hvilket muliggør forsinket start af Modigrafbehandling) eller alternativt hos klinisk stabile patienter uden antistofinduktion.
English: There is also evidence of gastrointestinal metabolism by CYP3A4 in the intestinal wall.
Danish: Der er også vist gastrointestinal metabolisme via CYP3A4 i den intestinale væg.
English: As detrimental effects on the newborn cannot be excluded, women should not breast-feed whilst receiving tacrolimus.
Danish: Da man ikke kan udelukke skadelige virkninger på den nyfødte, bør kvinder i behandling med tacrolimus ikke amme.
English: Patients are also at an increased risk of infections with viral hepatitis (for example, 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: Carbamazepine, metamizole and isoniazid have the potential to decrease tacrolimus concentrations.
Danish: Carbamazepin, metamizol og isoniazid kan potentielt nedsætte koncentrationen af tacrolimus.
English: If you take Modigraf during pregnancy, it may pass into your baby through the placenta.
Danish: Hvis De tager Modigraf, mens De er gravid, kan det overføres til barnet gennem moderkagen.
English: Modigraf reduces your body's defence mechanism (immune system), which will not be as good at fighting infections.
Danish: Modigraf nedsætter kroppens egen forsvarsmekanisme (immunsystemet), som så ikke vil kunne bekæmpe infektioner så godt som normalt.
English: For accurate measuring the volume of water you can use a syringe or graduated cylinder.
Danish: Til at afmåle det præcise volumen vand kan De anvende en sprøjte eller et målebæger.
English: Lymphoproliferative disorders and malignancies
Danish: Lymfoproliferative tilstande og maligniteter
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 for eksempel hovedpine, forandret mentaltilstand, krampeanfald og synsforstyrrelser, bør der udføres en radiologisk undersøgelse (f.eks. MRI).
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (Lapp lactase deficiency) eller glucose/galactose-malabsorption bør derfor ikke anvende dette lægemiddel.
English: dermatitis, photosensitivity rare:
Danish: dermatitis, fotosensibilisering
English: Monitoring of ciclosporin blood levels should be continued following conversion as the clearance of ciclosporin might be affected.
Danish: Man bør fortsætte med at måle ciclosporins blodkoncentrationer efter skiftet, da ciclosporins clearance kan være påvirket.
English: Modigraf is used to control your body's immune response enabling your body to accept the transplanted organ.
Danish: Modigraf benyttes til at kontrollere kroppens immunreaktion, således at kroppen kan acceptere det nye transplanterede organ.
English: Sachets consisting of layers of polyethylene terephtalate (PET), aluminium (Al) and polyethylene (PE).
Danish: Brevene består af lag af polyethylenterephtalat (PET), aluminium (A1) og polyethylen (PE).
English: This is because immunosuppressants like Modigraf could increase the risk of skin cancer.
Danish: Dette skyldes, at immundæmpende behandling som Modigraf kan øge risikoen for ondartede hudlidelser.
English: Peak blood concentrations achieved with these doses were above 150 nanogram/mL which is more than 6-fold higher than mean peak concentrations observed with Modigraf in clinical transplantation.
Danish: Peak-blodkoncentrationer opnået med disse doser var over 150 nanogram/ml, hvilket er mere end 6 gange højere end gennemsnitlige peak-koncentrationer observeret med Modigraf i forbindelse med transplantation.
English: Stopping your treatment with Modigraf may increase the risk of rejection of your transplanted organ.
Danish: Afbrydelse af behandlingen med Modigraf kan øge risikoen for afstødning af det transplanterede organ.
English: Gently tap on the closed end of the sachet and pour the contents of each sachet into the glass or cup containing the water.
Danish: Bank let på den lukkede ende af brevet og hæld indholdet af hvert brev i glasset eller koppen med vandet.
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: Baseret på dens høje molekylvægt, ringe vandopløselighed og stærke erytrocyt- og plasmaproteinbinding, vil tacrolimus ikke være dialysabelt.
English: In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly responsible for graft rejection.
Danish: Tacrolimus hæmmer specielt dannelsen af cytotoksiske lymfocytter, som er hovedansvarlige for transplantatafstødning.
English: Therefore, in this patient group, EBV-VCA serology should be ascertained before starting treatment with Modigraf.
Danish: Derfor bør EBV-VCAserologien for denne patientgruppe være klarlagt inden behandling med Modigraf.
English: This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. brev, dvs. det er i det væsentlige natrium-fri.
English: If conversion on the basis of equal quantities is not possible, the total daily dose of Modigraf should be rounded down to the nearest total daily dose possible with sachets 0.2 mg and 1 mg.
Danish: Hvis skift på basis af samme mængde ikke er muligt, bør den totale daglige Modigrafdosis rundes ned til nærmeste totale daglige dosis som er muligt med breve à 0,2 mg og 1 mg.
English: If necessary, tacrolimus dosing may commence by administering Modigraf granules suspended in water, via nasogastric tubing.
Danish: Om nødvendigt, kan dosering med tacrolimus påbegyndes ved at administrere Modigrafgranulat suspenderet i vand, via nasogastrisk sonde.
English: Gastrointestinal perforation has been reported in patients treated with tacrolimus.
Danish: Gastrointestinal perforation er rapporteret hos patienter behandlet med tacrolimus.
English: Take Modigraf on an empty stomach or 2 to 3 hours after a meal.
Danish: Tag Modigraf på tom mave eller 2 til 3 timer efter et måltid.
English: If you have accidentally taken too much Modigraf, contact your doctor or nearest hospital emergency department immediately.
Danish: Hvis De ved en fejltagelse har taget for meget Modigraf-granulat, skal De straks kontakte lægen eller den nærmeste skadestue.
English: Conversion between Modigraf and Prograf tacrolimus formulations In healthy subjects the systemic exposure to tacrolimus (AUC) for Modigraf was approximately 18% higher than that for Prograf capsules when administered as single doses.
Danish: Skift mellem tacrolimusformuleringerne Modigraf og Prograf Hos raske personer var den systemiske eksponering for tacrolimus (AUC) cirka 18 % højere for Modigraf end den tilsvarende for Prografkapsler, når der blev administreret som enkeltdosis.
English: Therefore, you may be more prone to infections while you are taking Modigraf.
Danish: Derfor kan De få flere infektioner, når De tager Modigraf.
English: It is not recommended that Modigraf is taken with ciclosporin (another medicine used for the prevention of transplant organ rejection).
Danish: Modigraf må ikke tages sammen med ciclosporin (et andet lægemiddel, der anvendes til at undgå afstødning af et transplanteret organ).
English: If equal doses are not possible, then the higher dose should be administered in the morning and the lower dose in the evening.
Danish: Hvis det ikke er muligt med 2 lige store doser, bør den højeste dosis administreres om morgenen og den laveste dosis om aftenen.
English: Overall, the safety profile of oral tacrolimus in these published studies appeared to be similar to what was reported in the large studies, where tacrolimus was used as primary treatment in liver, kidney and heart transplantation.
Danish: Oral tacrolimus-tolerance i disse publicerede undersøgelser svarer til, hvad der blev rapporteret fra store undersøgelser, hvor tacrolimus blev benyttet til primær behandling efter lever-, nyre- og hjertetransplantationer.
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 hæmmer T-celleaktivering og T-hjælpercelleafhængig B-celleproliferation samt dannelsen af lymfokiner (såsom interleukin-2 og -3 og γ-interferon) og ekspression af interleukin-2 receptoren.
English: In current clinical practice, whole blood levels are monitored using immunoassay methods.
Danish: I nuværende klinisk praksis måles koncentrationer i fuldblod med immunoassaymetoder.
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: Ved oral overdosering kan maveskylning og/eller indgift af adsorberende stoffer (såsom medicinsk kul) være nyttigt kort tid efter indtagelse.
English: The oral bioavailability of tacrolimus was reduced when it was administered after a meal.
Danish: Den orale biotilgængelighed af tacrolimus blev reduceret, hvis det blev indgivet efter et måltid.
English: Treatment of allograft rejection after kidney or liver transplantation - adults and paediatric patients For conversion from other immunosuppressants to twice daily Modigraf, treatment should begin with the initial oral dose recommended for primary immunosuppression.
Danish: Afstødningsbehandling efter nyre- eller levertransplantation - voksne og pædiatriske patienter Ved skift fra andre immunsuppressive midler til Modigraf to gange daglig, bør behandlingen påbegyndes med den anbefalede orale startdosis for primær immunsuppression.
English: Published clinical experience from a single centre on the use of oral tacrolimus for primary treatment following intestinal transplantation showed that the actuarial survival rate of 155 patients (65 intestine alone, 75 liver and intestine, and 25 multivisceral) receiving tacrolimus and prednisone was 75% at 1 year, 54% at 5 years, and 42% at 10 years.
Danish: Publicerede kliniske resultater fra et enkelt center om brug af oral tacrolimus som primær behandling efter intestinale transplantationer viste, at overlevelsesraten hos 155 patienter (65 intestinal alene, 75 lever og tarm samt 25 multivicerale), der fik tacrolimus og prednison, var på 75 % efter 1 år, på 54 % efter 5 år og på 42 % efter 10 år.
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 intakt tacrolimus blev fundet i urin og fæces, hvilket indikerer, at næsten al tacrolimus metaboliseres før eliminering, idet størstedelen bliver elimineret med galden.
English: Decreases in AUC (2 to 12%) and Cmax (15 to 38%), and an increase in tmax (38 to 80%) in whole blood were evident.
Danish: Der var et fald i AUC (2-12 %) og Cmax (15-38 %) og en øgning af tmax (38-80 %) i fuldblod.
English: Modigraf should not be switched with Advagraf as a clinically relevant difference in bioavailability between the two formulations cannot be excluded.
Danish: Modigraf bør ikke substitueres med Advagraf, da klinisk relevant forskel i biotilgængelighed mellem de to lægemiddelformer ikke kan udelukkes.
English: Paediatric data
Danish: Pædiatriske data
English: What you need to know before you take Modigraf Do not take Modigraf
Danish: Det skal De vide, før De begynder at tage Modigraf Tag ikke Modigraf
English: In case of sun exposure, wear appropriate protective clothing and use a sunscreen with a high sun protection factor.
Danish: Bær passende beskyttende beklædning og anvend en solcreme med høj solbeskyttende faktor, hvis De opholder Dem i solen.
English: Accordingly, high-risk patients, particularly young children and those receiving substantial immunosuppression should be monitored, using such procedures as echocardiography or ECG pre- and post-transplant (e.g. initially at 3 months and then at 9-12 months).
Danish: Derfor skal patienter i risikogruppen, især små børn og patienter i intensiv immunsuppression kontrolleres med f.eks. ekkokardiografi eller EKG før og efter transplantation (f.eks. efter 3 måneder i begyndelsen af behandlingen og igen efter 9-12 måneder).
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, bør man overveje at ændre det immunsuppressive regime.
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: Ved skift til andre lægemiddelformer uanset type bør terapeutisk monitorering og dosisjusteringer finde sted for at sikre, at systemisk eksponering for tacrolimus opretholdes.
English: Mechanism of action and pharmacodynamic effects 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: Virkningsmekanisme og farmakodynamiske virkninger På molekylært niveau synes virkningen af tacrolimus at være medieret af binding til cytosolprotein (FKBP12), som også er ansvarlig for den intracellulære akkumulering af præparatet.
English: Endocrine disorders rare:
Danish: Det endokrine system Sjælden:
English: Modigraf granules should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption (see section 5.2).
Danish: Modigrafgranulat bør sædvanligvis indtages på tom mave eller mindst 1 time før eller 2 - 3 timer efter et måltid for at opnå maksimal absorption (se pkt.
English: In the early years the initial oral dose of tacrolimus was 0.3 mg/kg/day.
Danish: I de første år var den initiale orale dosis af tacrolimus 0,3 mg/kg/dag.