FrancophonIA/ELRC3.0 huggingface dataset:
English: The mechanism for mycophenolate mofetil induced PRCA is unknown.
Danish: Mekanismen for mycophenolatmofetil-induceret PRCA er ukendt.
English: • serious disease of the central nervous system (JC virus associated progressive multifocal leucoencephalopathy)
Danish: • alvorlig sygdom i centralnervesystemet (JC-virus associeret med progressiv multifokal leukoencefalopati)
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteret og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered with aciclovir in comparison to the administration of aciclovir alone.
Danish: Der blev observeret højere aciclovir-plasmakoncentrationer, når mycophenolatmofetil blev administreret sammen med aciclovir sammenlignet med administration af aciclovir alene.
English: Pharmacotherapeutic group: immunosuppressive agents ATC code: LO4A A06
Danish: Farmakoterapeutisk klassifikation: immunsuppressive midler, ATC-kode L04AA06
English: Cases of hepatitis due to reactivation of hepatitis B or hepatitis C have been reported in carrier patients treated with immunosuppressants.
Danish: Tilfælde af hepatitis, som skyldes reaktivering af hepatitis B eller hepatitis C, er rapporteret hos smittebærere behandlet med immunsuppressiva.
English: The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not considered clinically significant.
Danish: Ændringerne i MPAG's (MPA's fenoliske glukuronid) farmakokinetik (MPAG steg med 8 %) var minimale og anses ikke for klinisk signifikante.
English: System organ class Frequency Adverse drug reactions
Danish: Systemorgan-klasse Hyppighed
English: The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey.
Danish: De hæmopoietiske og lymfoide organsystemer var de første primære organer, der blev afficeret i de toksikologiske studier, der blev foretaget med mycophenolatmofetil på rotter, mus, hunde og aber.
English: AcMPAG is pharmacologically active and is suspected to be responsible for some of MMF´s side effects (diarrhoea, leucopenia).
Danish: AcMPAG er farmakologisk aktiv og mistænkes for at være ansvarlig for nogle af mycophenolatmofetils bivirkninger (diarré, leukopeni).
English: Ask your pharmacist how to throw away medicines no longer required.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: In cases of sustained, clinically relevant hypogammaglobulinaemia, appropriate clinical action should be considered taking into account the potent cytostatic effects that mycophenolic acid has on T- and B-lymphocytes.
Danish: I tilfælde af vedvarende, klinisk relevant hypogammaglobulinæmi skal passende kliniske tiltag overvejes under hensyntagen til den potente cytostatiske virkning, mycophenolsyre har på T-og B-lymfocytter.
English: If neutropenia develops (absolute neutrophil count <°1.3°x 103/°µl) it may be appropriate to interrupt or discontinue Myfenax.
Danish: Hvis der optræder neutropeni (det absolutte neutrofillocyttal < 1,3 x 103/µl), skal behandlingen med Myfenax måske afbrydes eller stoppes.
English: Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to immunosuppression.
Danish: Ældre patienter (≥65 år) har i almindelighed større risiko for bivirkninger pga. immunsuppression.
English: Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
Danish: Overfølsomhedsreaktioner, herunder angioneurotisk ødem og anafylaktiske reaktioner, er blevet rapporteret.
English: • Olfactory nerve agenesis.
Danish: • nervus olfactorius agenesi.
English: Therapeutic drug monitoring of MPA may be appropriate when switching combination therapy (e.g. from ciclosporin to tacrolimus or vice versa) or to ensure adequate immunosuppression in patients with high immunological risk (e.g. risk of rejection, treatment with antibiotics).
Danish: Terapeutisk lægemiddelovervågning af MPA kan være hensigtsmæssigt ved skift i kombinationsbehandling (f.eks fra ciclosporin til tacrolimus eller omvendt) eller for at sikre tilstrækkelig immunosuppression hos patienter med høj immunologisk risiko (f.eks risiko for afstødning, behandling med antibiotika).
English: Caution is therefore recommended when administering these drugs concomitantly with mycophenolate mofetil.
Danish: Forsigtighed anbefales derfor, når disse lægemidler administreres samtidigt med mycophenolatmofetil.
English: Agranulocytosis (≥1/1000 to <1/100) and neutropenia have been reported; therefore regular monitoring of patients taking Myfenax is advised (see section 4.4).
Danish: Agranulocytose (≥ 1/1.000 til < 1/100) og neutropeni er rapporteret; derfor tilrådes regelmæssig monitorering af patienter i behandling med Myfenax (se pkt.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs http://www.ema.europa.eu hjemmeside.
English: • overgrowth of the gum tissue
Danish: • overvækst af tandkødet
English: • if you are planning to become pregnant, or if you get pregnant while taking Myfenax.
Danish: - Hvis du planlægger at blive gravid, eller hvis du bliver gravid, mens du tager Myfenax.
English: Very commonCommon
Danish: Meget almindelig
English: • Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingooophorectomy).
Danish: • Dine æggeledere og begge dine æggestokke er blevet fjernet ved operation (bilateral salpingoooforektomi).
English: Myfenax is used to prevent your body rejecting a transplanted kidney, heart or liver.
Danish: Myfenax anvendes til at forhindre kroppen i at afstøde en transplanteret nyre, hjerte eller lever.
English: Myfenax should not be used in children and adolescents (aged 2 to 18) for heart or liver transplantation.
Danish: Myfenax bør ikke anvendes til børn og unge (2-18 år) i forbindelse med hjerte- eller levertransplantation.
English: • For 6°weeks after you stop taking Myfenax.
Danish: • I 6 uger efter du er stoppet med at tage Myfenax.
English: Do not stop taking Myfenax because you feel better.
Danish: Stop ikke med at tage Myfenax, bare fordi du måtte få det bedre.
English: Patients should be advised that during treatment with Myfenax, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Danish: Patienterne skal underrettes om, at under behandling med Myfenax kan vaccinationer være mindre effektive, og levende svækkede vacciner bør undgås (se pkt.
English: • You have sex without using an effective method of contraception.
Danish: • Hvis du har haft sex uden at anvende sikker prævention.
English: • low/high blood pressure, widening of blood vessels
Danish: • lavt/højt blodtryk, blodkarudvidelse
English: It will be explained that the correct course of action, based on an assessment of the individual benefit-risk, will be determined on a case by case basis through a discussion between the treating physician and the patient.
Danish: Det skal forklares, at den bedste fremgangsmåde vil blive fastlagt fra tilfælde til tilfælde, gennem en diskussion mellem den behandlende læge og patienten og baseret på fordele versus risici for den enkelte patient,
English: If a capsule breaks open accidentally, wash any powder from your skin with soap and water.
Danish: Hvis en kapsel går i stykker ved et uheld, og du har fået noget af pulveret på huden, skal du vaske huden med sæbe og vand.
English: Pregnancy, contraception and breast-feeding Contraception in women taking Myfenax
Danish: Graviditet, prævention og amning Prævention hos kvinder, som tager Myfenax
English: As general advice to minimise the risk for skin cancer, exposure to sunlight and ultraviolet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Danish: For at minimere risikoen for hudkræft må det generelt tilrådes, at udsættelse for sollys og ultraviolet (UV) lys begrænses ved, at der bæres beskyttende beklædning, og ved at der anvendes en solblokker med en høj beskyttelsesfaktor.
English: A reduction in the AUC of MPA of approximately 40% is associated with the co-administration of cholestyramine (4°g TID), indicating that there is a significant amount of enterohepatic recirculation.
Danish: En reduktion af MPA AUC på ca. 40 % er associeret til den samtidige administration af colestyramin (4 g tre gange dagligt), hvilket indikerer, at der er en betragtelig enterohepatisk recirkulation.
English: Mycophenolate mofetil
Danish: Mycophenolatmofetil
English: Myfenax contains sodium
Danish: Myfenax indeholder natrium
English: In volunteers with alcoholic cirrhosis, hepatic MPA glucuronidation processes were relatively unaffected by hepatic parenchymal disease.
Danish: Hos frivillige med alkoholisk cirrhose var de hepatiske MPA glukuronideringsprocesser forholdsvis upåvirkede af den hepatiske parenkymsygdom.
English: Physicians should ensure that women taking mycophenolate understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult their physician if there is a possibility of pregnancy.
Danish: Lægen skal sikre, at kvinder, som tager mycophenolat, forstår risikoen for skader hos barnet, nødvendigheden af sikker kontraception og nødvendigheden af at kontakte lægen straks, hvis der er risiko for graviditet.
English: Before starting Myfenax treatment, women of childbearing potential must have two negative serum or urine pregnancy tests with a sensitivity of at least 25 mIU/mL in order to exclude unintended exposure of the embryo to mycophenolate.
Danish: Før Myfenax-behandlingen initieres, skal fertile kvinder have to negative graviditetstests (serum eller urin) med en sensitivitet på mindst 25 mIE/ml for at udelukke en uønsket mycophenolat-eksponering til fosteret.
English: The educational programme is aimed at ensuring that the health professionals and patients are aware of the teratogenicity and mutagenicity, the need for pregnancy tests before starting therapy with Myfenax, the contraceptive requirements for both male and female patients and what to do in case of pregnancy during treatment with Myfenax.
Danish: Uddannelsesprogrammets formål er at sikre, at sundhedspersonale og patienter er bevidste om teratogeniciteten og mutageniciteten, nødvendigheden af graviditetstests før behandlingen med Myfenax initieres, kravene til prævention for både mandlige og kvindelige patienter, og hvilke tiltag der skal initieres, hvis der opstår graviditet under behandling med Myfenax.
English: • You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
Danish: • Du ikke får din menstruation eller tror, du ikke har fået din menstruation eller har en usædvanlig menstruation eller tror, at du er gravid.
English: • decrease in the amount of antibodies in the blood
Danish: • fald i antallet af antistoffer i blodet
English: Myfenax capsules should be handled with care.
Danish: Myfenax kapsler skal håndteres forsigtigt.
English: The Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme and a follow-up pregnancy questionnaire, including communication media,
Danish: Indehaveren af markedsføringstilladelsen og de nationale myndigheder skal være enige om indholdet og formen af uddannelsesprogrammet og et opfølgende spørgeskema ved graviditet, herunder også kommunikationsplaner, distributionsmetoder og alle andre aspekter af programmet.
English: Treatment with Myfenax should be initiated and maintained by appropriately qualified transplant specialists.
Danish: Behandling med Myfenax bør påbegyndes og fortsættes af specialister med særligt kendskab til transplantationer.
English: • if you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription, as mycophenolate causes birth defects and miscarriage.
Danish: - Hvis du er kvinde og kan blive gravid, og der ikke foreligger en negativ graviditetstest, før du har fået den første recept, eftersom mycophenolat forårsager medfødte misdannelser og abort.
English: In healthy volunteers, no significant interaction was observed when mycophenolate mofetil was concomitantly administered with norfloxacin or metronidazole separately.
Danish: Der blev ikke observeret nogen signifikant interaktion hos raske frivillige, når mycophenolatmofetil blev administreret samtidigt enten med norfloxacin eller metronidazol hver for sig.
English: The proportion of patients with CMV viraemia/syndrome was 13.5%.
Danish: Andelen af patienter med CMV-viræmi/syndrom var
English: • The other ingredients are:
Danish: - Øvrige indholdsstoffer:
English: Hard capsule (capsule)
Danish: Kapsler, hårde (kapsler)
English: • During your entire treatment with Myfenax
Danish: • Under hele behandlingen med Myfenax
English: • Guide for patients
Danish: • En vejledning for patienter
English: • if you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
Danish: - Hvis du ikke anvender sikker prævention (se ”Graviditet, prævention og amning”).
English: Patients receiving Myfenax should be monitored for neutropenia, which may be related to Myfenax itself, concomitant medicinal products, viral infections, or some combination of these causes.
Danish: Patienter, der får Myfenax, bør monitoreres for neutropeni, som kan relateres til Myfenax, samtidig lægemidler, virale infektioner eller en eller anden kombination af disse årsager.
English: Indigo carmine (E132)
Danish: Indigo carmin (E132)
English: Stopping your treatment with Myfenax may increase the chance of rejection of your transplanted organ.
Danish: Hvis behandlingen med Myfenax stoppes, kan risikoen for afstødning af det transplanterede organ øges.
English: Myfenax has not been shown to impair your ability to drive or operate machines.
Danish: Det er ikke påvist, at Myfenax påvirker evnen til at føre motorkøretøj eller betjene maskiner.
English: MPA at clinically relevant concentrations is 97% bound to plasma albumin.
Danish: Ved klinisk relevante koncentrationer er ca. 97 % af MPA bundet til plasma-albumin.
English: Gingival hyperplasia (≥1/100 to <1/10), colitis including cytomegalovirus colitis (≥1/100 to <1/10),
Danish: Gingival hyperplasi (≥ 1/100 til <1/10), colitis inklusive cytomegalovirus colitis, (≥ 1/100 til < 1/10),
English: Myfenax is an inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Danish: Myfenax er en inosinmonofosfatdehydrogenase-(IMPDH) hæmmer.
English: Antibiotics eliminating β-glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA enterohepatic recirculation thus leading to reduced systemic MPA exposure.
Danish: Antibiotika, der eliminerer β-glukuronidaseproducerende bakterier i tarmene (f.eks. aminoglycosid, cephalosporin, fluorquinolon og penicillinklasser af antibiotika) kan interferere med MPAG/MPA enterohepatisk recirkulation, hvilket fører til reduceret systemisk MPA-eksponering.
English: Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Danish: Myfenax er, i kombination med ciclosporin og kortikosteroider, indiceret til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre-, hjerte-, eller levertransplantater.
English: • Malformations of the fingers (e.g. polydactyly, syndactyly);
Danish: • misdannelser af fingre (f.eks. polydaktyli, syndaktyli);
English: However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30% following a single dose of mycophenolate mofetil.
Danish: Kombinationen af norfloxacin og metronidazol reducerede MPA-eksponeringen med ca. 30 % efter én mycophenolatmofetil-enkeltdosis.
English: Caution should be exercised when switching combination therapy from regimens containing immunosuppressants, which interfere with MPA enterohepatic recirculation, e.g. ciclosporin, to others devoid of this effect, e.g. tacrolimus, sirolimus, belatacept, or vice versa, as this might result in changes of MPA exposure.
Danish: Der skal udvises forsigtighed ved skift fra kombinationsbehandlingsregimer indeholdende immunsuppressiva, som interfererer med MPAs enterohepatiske kredsløb, f.eks. ciclosporin, til andre som ikke interfererer, f.eks. tacrolimus, sirolimus, belatacept, eller omvendt, da dette kan resultere i ændring af eksponeringen af MPA.
English: Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience.
Danish: Der er modtaget rapporter om overdosering med mycophenolatmofetil fra kliniske studier og efter markedsføring.
English: • Congenital choroid plexus cyst;
Danish: • medfødt plexus choriodeus-cyste;
English: Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin.
Danish: Kapslerne må ikke åbnes eller knuses, og pulveret i kapslerne må ikke indåndes eller komme i berøring med huden.
English: Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections caused by polyomaviruses (BK virus associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy PML).
Danish: Sådanne infektioner inkluderer latent viral reaktivering, såsom hepatitis B- eller hepatitis Creaktivering og infektioner forårsaget af polyomavira (BK-virus associeret med nefropati, JC-virus associeret med progressiv multifokal leukoencefalopati PML).
English: Very common Sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster
Danish: Sepsis, gastrointestinal candidiasis, urinvejsinfektioner, Herpes simplex, herpes zoster
English: MPA is metabolised principally by glucuronyl transferase (isoform UGT1A9) to form the inactive phenolic glucuronide of MPA (MPAG).
Danish: MPA metaboliseres hovedsageligt af glukuronyltransferase (isoform UGT1A9) til et inaktivt phenolglukuronid af MPA (MPAG).
English: The first dose will be given within 72°hours after the transplant operation.
Danish: Den første dosis gives inden for 72 timer efter transplantationen.
English: Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended doses.
Danish: Gastrointestinale virkninger observeredes hos hunde ved systemiske niveauer lig med eller mindre end det kliniske niveau ved den anbefalede dosis.
English: • change of the shape of certain white blood cells
Danish: • ændring af formen af visse hvide blodceller
English: • Are you taking any medicines containing: o azathioprine or other immunosuppressive agents (which are sometimes given to patients after a transplant operation), o cholestyramine (used to treat patients with high blood cholesterol), o rifampicin (antibiotic), o antacids or proton pump inhibitors (used for acid problem in your stomach such as indigestion), o phosphate binders (used in patients with chronic kidney failure to reduce the absorption of phosphate), o antibiotics (used to treat bacterial infections), o isavuconazole (used to treat fungal infections), o telmisartan (used to treat high blood pressure) o or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
Danish: • Tager du nogen form for medicin, som indeholder: o azathioprin eller andre stoffer der nedsætter immunforsvaret (som undertiden gives til patienter efter en transplantationsoperation), o colestyramin (som bruges til behandling af patienter med for højt kolesteroltal), o rifampicin (antibiotika), o mavesårsmedicin eller protonpumpehæmmere (bruges mod for meget mavesyre, f.eks. ved fordøjelsesbesvær, phosphatbindere (bruges til patienter med kronisk nyresvigt for at reducere absorptionen af phosphat), o antibiotika - bruges til behandling af bakterielle infektioner o isavuconazol - bruges til behandling af svampeinfektioner o telmisartan - bruges til behandling af forhøjet blodtryk o eller anden medicin (inklusive håndkøbsmedicin), som din læge ikke er bekendt med?
English: Because MPAG plasma concentrations are increased in the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs, e.g. valaciclovir, to compete for tubular secretion and further increases in concentrations of both substances may occur.
Danish: Da MPAG-plasmakoncentrationer forhøjes ved nedsat nyrefunktion, lige som aciclovir-koncentrationerne bliver det, er der en mulighed for, at mycophenolatmofetil og aciclovir, eller deres prodrugs, f.eks. valaciclovir, vil konkurrere om den tubulære sekretion, og at der kan ske yderligere forhøjelser af koncentrationerne af begge stoffer.
English: Patients receiving Myfenax should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Danish: Patienter, som får Myfenax, skal informeres om straks at indberette alle tegn på infektion, uventede blodudtrædninger, blødning eller andre manifestationer på knoglemarvsdepression.
English: • shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung).
Danish: • kortåndethed, hoste, som kan skyldes bronkiektasi (en tilstand, hvor bronkierne er abnormalt udvidede) eller lungefibrose (dannelse af ar-væv i lungene).
English: Hypromellose (HPMC 2910) Titanium dioxide (E171) Macrogol (PEG 400) Talc
Danish: Tabletovertræk Hypromellose (HPMC 2910) Titandioxid (E171) Macrogol (PEG 400) Talcum
English: Haemodialysis would not be expected to remove clinically significant amounts of MPA or MPAG.
Danish: Hæmodialyse forventes ikke at kunne fjerne klinisk signifikante mængder MPA eller MPAG.
English: There is no basis for Myfenax dose adjustment following cardiac transplant rejection.
Danish: Der er ikke grundlag for justering af Myfenax-dosis efter afstødning af hjertetransplantat.
English: • high level of cholesterol and/or lipids in the blood
Danish: • højt niveau af kolesterol og/eller fedtstoffer i blodet
English: Spontaneous abortion (rate of 45% to 49%) and congenital malformations (estimated rate of 23% to 27%) have been reported following MMF exposure during pregnancy.
Danish: Spontane aborter (frekvens på 45% til 49 %) og medfødte misdannelser (estimeret frekvens på 23% til 27 %) er blevet rapporteret efter mycophenolatmofetil-eksponering under graviditet.
English: Myfenax is a medicine that is used to suppress immune activity.
Danish: Myfenax er medicin, der anvendes til at nedsætte immunforsvaret.
English: Note: 501 (2°g mycophenolate mofetil daily), 289 (3°g mycophenolate mofetil daily) and 277 (2°g intravenous/3°g oral mycophenolate mofetil daily) patients were treated in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively.
Danish: Note: 501 (2 g mycophenolatmofetil daglig), 289 (3 g mycophenolatmofetil daglig) og 277 (2 g intravenøs/ 3 g oral mycophenolatmofetil daglig) patienter i fase III studier blev behandlet med henblik på forebyggelse af afstødelse efter henholdsvis nyre-, hjerte- og levertransplantation.
English: These are insufficient to make dose recommendations and therefore use in this age group is not recommended.
Danish: De er ikke tilstrækkelige til at komme med dosisrekommendationer, og det anbefales derfor ikke at anvende Myfenax til denne aldersgruppe.
English: If neutropenia develops, dosing with Myfenax should be interrupted or the dose reduced (see section 4.4).
Danish: Hvis der udvikles neutropeni, skal administrationen af Myfenax afbrydes eller dosis nedsættes (se pkt.