FrancophonIA/ELRC3.0 huggingface dataset:
English: Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation.
Danish: Mycophenolatmofetil er blevet sat i forbindelse med en øget incidens af bivirkninger i fordøjelsessystemet, inklusive sjældne tilfælde af ulceration, blødning og perforation.
English: TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9AG United Kingdom
Danish: TEVA UK Ltd Brampton Road Hampden Park Eastbourne East Sussex BN22 9 AG England
English: It is expected that an overdose of mycophenolate mofetil could possibly result in oversuppression of the immune system and increase susceptibility to infections and bone marrow suppression (see section 4.4).
Danish: Det forventes, at en overdosering af mycophenolatmofetil muligvis kan medføre oversuppression af immunsystemet og dermed forøge modtageligheden over for infektioner og knoglemarvsdepression (se pkt.
English: • infection of the lung, flu, infection of the respiratory tract
Danish: • lungebetændelse, influenza, infektion i luftvejene
English: Hypromellose (HPMC 2910) Titanium dioxide (E171)
Danish: Hypromellose (HPMC 2910) Titandioxid (E 171)
English: In patients with delayed renal graft function post-transplant, mean MPA AUC (0-12°h) was comparable to that seen in post-transplant patients without delayed graft function.
Danish: Hos patienter med forsinket renal transplantatfunktion post-transplantativt var middelværdi for MPA AUC0-12 timer sammenlignelig med, hvad man så hos post-transplantations-patienter uden forsinket transplantatfunktion.
English: Body
Danish: Krop
English: Pharmacokinetic behaviour of mycophenolate mofetil in the elderly (≥°65 years) has not been formally evaluated.
Danish: Ældre patienter Farmakokinetikken hos ældre (≥ 65 år) er ikke systematisk undersøgt.
English: No substantial alteration of MPA pharmacokinetics is anticipated and mycophenolate mofetil dose adjustment is not required.
Danish: Der forudses ingen væsentlig ændring af MPA's farmakokinetik, og dosisjustering af mycophenolatmofetil er ikke nødvendig.
English: These effects occurred at systemic exposure levels that are equivalent to or less than the clinical exposure at the recommended dose of 2 g/day for renal transplant recipients.
Danish: Disse effekter forekom ved systemiske eksponeringsniveauer som er lig med eller mindre end de kliniske niveauer ved den anbefalede dosis på 2 g dagligt til nyretransplanterede patienter.
English: Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18°years) given 600°mg/m2 mycophenolate mofetil orally twice daily.
Danish: Farmakokinetiske parametre evalueredes hos 49 nyretransplanterede børn (2-18 år), som fik 600 mg/m2 mycophenolatmofetil oralt to gange dagligt.
English: Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
Danish: Pneumoni, influenza, infektion i luftrøret, respiratorisk moniliasis, gastrointestinal infektion, candidiasis, gastroenteritis, infektion, bronkitis, pharyngitis, sinuitis, svampeinfektion i huden, hud candidiasis, vaginal candidiasis, rhinitis
English: • Physician educational material
Danish: • Uddannelsesmateriale for læger
English: Advice on action if a pregnancy occurs or is suspected during or shortly after being treated with mycophenolate mofetil.
Danish: Vejledning i, hvilke tiltag der skal igangsættes, hvis graviditet indtræder, eller hvis der er en mistanke om, at graviditet er indtrådt under behandling med mycophenolatmofetil eller kort tid efter behandlingen.
English: • serious inflammation of the heart and its valves
Danish: • alvorlig betændelse i hjertet og hjerteklapperne
English: Therefore, a change in the dose of Myfenax should not normally be necessary in the absence of clinical evidence of graft dysfunction.
Danish: Derfor er det normalt ikke nødvendigt at ændre dosis af CellCept, hvis der ikke er klinisk evidens for dysfunktion af transplantatet.
English: Contents of the pack and other information What Myfenax contains
Danish: Pakningsstørrelser og yderligere oplysninger Myfenax indeholder:
English: Intravenous mycophenolate mofetil should be administered for the first 4°days following hepatic transplant, with oral Myfenax initiated as soon after this as it can be tolerated.
Danish: Mycophenolatmofetil skal gives intravenøst i de 4 første dage efter en levertransplantation og herefter skal oral administration påbegyndes, så snart det tåles.
English: Adverse reactions, probably or possibly related to mycophenolate mofetil, reported in ≥1/10 and in ≥1/100 to <1/10 of patients treated with mycophenolate mofetil in the controlled clinical trials of renal (2°g data), cardiac and hepatic transplant patients are listed in the following table.
Danish: Bivirkninger, som var ”sandsynligt relateret” eller ”muligt relateret” til mycophenolatmofetil, og som rapporteredes hos ≥1/10 og hos ≥1/100 til <1/10 af de patienter, der blev behandlet med mycophenolatmofetil i de kontrollerede kliniske studier med nyre- (2 g data), hjerte- og levertransplanterede patienter, er anført i den følgende tabel.´
English: Do not take Myfenax if you are breast-feeding.
Danish: Tag ikke Myfenax, hvis du ammer.
English: • fungal infections (e.g. of the respiratory tract, skin and vagina)
Danish: • svampeinfektioner (f.eks. i luftvejene, huden og skeden)
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil (see section 4.4).
Danish: Tilfælde af pure red cell aplasia (PRCA) er rapporteret hos patienter, behandlet med mycophenolatmofetil (se pkt 4.4)
English: Oral Myfenax should be initiated within 5 days following transplantation.
Danish: Oralt Myfenax bør gives inden for 5 døgn efter transplantation.
English: • inflammation of the colon which causes abdominal pain or diarrhoea (sometimes caused by cytomegalovirus), ulcer of the stomach and/or duodenum, inflammation of the stomach,
Danish: • tyktarmsbetændelse, som giver mavesmerter eller diarre (nogle gange forårsaget af cytomegalovirus), mavesår og/eller sår i tolvfingertarmen, betændelse i maven, spiserøret og/eller munden og læberne
English: Package leaflet: Information for the user Myfenax 250 mg hard capsules
Danish: Indlægsseddel: Information til brugeren Myfenax 250 mg kapsler, hårde
English: • fever, feeling of coldness, pain, feeling unwell, feeling weak and feeble
Danish: • feber, kuldefornemmelse, smerter, følelse af utilpashed, svaghed og kraftløshed
English: • growth of the skin, rash, acne, hair loss
Danish: • vækst i huden, udslæt, akne, hårtab
English: However, keep taking Myfenax until you see him or her.
Danish: Fortsæt dog behandlingen med Myfenax, indtil du ser lægen.
English: Paediatric population No data are available for paediatric cardiac transplant patients.
Danish: Pædiatrisk population Der foreligger ingen data vedrørende hjertetransplantationer hos pædiatriske patienter.
English: Patients treated with immunosuppressants, including Myfenax, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Danish: Patienter, som bliver behandlet med immunsuppressiva, herunder Myfenax, har en øget risiko for opportunistiske infektioner (bakteriel, svampe, viral og protozoel), dødelige infektioner og sepsis (se pkt.
English: In patients with renal impairment in whom Myfenax and ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered the dose recommendations for ganciclovir should be observed and patients monitored carefully.
Danish: Hos patienter med nedsat nyrefunktion, som får Myfenax og ganciclovir, eller deres prodrugs, f.eks. valganciclovir, samtidig bør dosisanbefalingerne for ganciclovir følges, og patienterne monitoreres omhyggeligt.
English: Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed)).Your baby may be affected by one or more of these.
Danish: Medfødte misdannelser, som har været rapporteret, inkluderer abnormiteter i ører, øjne og ansigt (læbe-gane spalte) eller i fingrenes udvikling, samt i hjerte, spiserør, nyrer og nervesystem (f.eks. manglende sammenvoksning af rygraden (spina bifida).
English: Contraception (see section 4.6)
Danish: Kontraception (se pkt.
English: Each tablet contains 500 mg mycophenolate mofetil.
Danish: Hver tablet indeholder 500 mg mycophenolatmofetil.
English: There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate mofetil, some of which have been fatal.
Danish: Der har været indberetninger om aplastisk anæmi og knoglemarvsdepression hos patienter behandlet med mycophenolatmofetil, hvor nogle har været dødelige.
English: Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide.
Danish: Sort blæk indeholder: Shellac, sort jernoxid (E172), propylenglycol og kaliumhydroxid.
English: Therefore Myfenax is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection.
Danish: Derfor er Myfenax kontraindiceret under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet.
English: Adverse reactions, probably or possibly related to mycophenolate mofetil, reported in patients treated with mycophenolate mofetil in renal, cardiac and hepatic clinical trials when used in combination with ciclosporin and corticosteroids
Danish: Bivirkninger, som var ”sandsynligt relateret” eller ”muligt relateret” til mycophenolatmofetil, og som rapporteredes hos patienter, som blev behandlet med mycophenolatmofetil i kombination med ciclosporin og kortikosteroider i de kliniske nyre-, hjerte- og leverstudier
English: Myfenax should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients listed in section 6.1.
Danish: Myfenax må ikke anvendes til patienter med overfølsomhed over for mycophenolatmofetil, mycophenolsyre eller over for et eller flere af hjælpestofferne anført i pkt.
English: Paediatric population aged 2 to 18 years The recommended dose of mycophenolate mofetil is 600 mg/m2 administered orally twice daily (up to a maximum of 2 g daily).
Danish: Pædiatrisk population 2-18 år Den anbefalede dosis af mycophenolatmofetil er 600 mg/m2 oralt to gange dagligt (højst 2 g dagligt).
English: Myfenax is contraindicated during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
Danish: Myfenax er kontraindiceret under graviditeten, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet.
English: The capsule body is caramel opaque, printed with ‘250' axially in black ink.
Danish: Kapslens ”krop” er uigennemsigtig karamelfarvet, printet med ”250” aksialt med sort blæk.
English: Do not take Myfenax,
Danish: Tag ikke Myfenax
English: Male patients of reproductive potential should be made aware of and discuss the potential risks of fathering a child with a qualified health-care professional.
Danish: Kvalificeret sundhedspersonale bør gøre mandelige patienter med reproduktivt potentiale opmærksomme på og tale med dem om de potentielle risici ved at at blive far til et barn.
English: If you forget to take Myfenax
Danish: Hvis du har glemt at tage Myfenax
English: In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2) were 28-75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Danish: I et enkelt-dosis studie (6 personer per gruppe) blev middelværdi for plasma MPA AUC hos personer med svær, kronisk nedsat nyrefunktion (glomerulær filtrationsrate < 25 ml/min/1,73 m2) observeret til 28-75 % højere i forhold til middelværdierne hos normale, sunde personer eller personer med let nedsat nyrefunktion.
English: In contrast, if concomitant ciclosporin treatment is stopped, an increase in MPA AUC of around 30% should be expected.
Danish: Derimod må en stigning i MPA's AUC på ca. 30 % forventes, hvis samtidig ciclosporinbehandling seponeres.
English: This means taking 2°tablets in the morning then 2°tablets in the evening.
Danish: Det vil sige, at man skal tage 2 tabletter om morgenen og 2 tabletter om aftenen.
English: Magnesium stearate Croscarmellose sodium
Danish: Magnesiumstearat Croscarmellosenatrium
English: Myfenax 250 mg Capsules
Danish: Myfenax 250 mg kapsler
English: Female patients of reproductive potential must be made aware of the increased risk of pregnancy loss and congenital malformations at the beginning of the treatment and must be counselled regarding pregnancy prevention and planning.
Danish: Når behandlingen initieres, skal kvinder informeres om den øgede risiko for abort og medfødte misdannelser, og de skal vejledes omkring prævention og graviditetsplanlægning.
English: Paediatric population No data are available for paediatric hepatic transplant patients.
Danish: Pædiatrisk population Der foreligger ingen data vedrørende levertransplantationer hos pædiatriske patienter.
English: Drugs which interfere with MPA's enterohepatic cycle (e.g. cholestyramine, antibiotics) should be used with caution due to their potential to reduce the plasma levels and efficacy of mycophenolate mofetil (see also section 4.5).
Danish: Lægemidler, som påvirker MPAs enterohepatiske kredsløb (f.eks. colestyramin, antibiotika) bør anvendes med forsigtighed, da de potentielt kan reducere plasmaniveauet og virkningen af mycophenolatmofetil (se også pkt.
English: Myfenax treatment should not be initiated in women of child bearing potential without providing a pregnancy test result to rule out unintended use in pregnancy (see section 4.6).
Danish: Myfenax -behandling må ikke initieres hos kvinder i den fertile alder uden at en negativ graviditetstest foreligger, for at udelukke en uønsket anvendelse under graviditet (se pkt.
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressants.
Danish: Tilfælde af pure red cell aplasia (PRCA) er blevet rapporteret hos patienter i behandling med mycophenolatmofetil i kombination med andre immunsuppressiva.
English: It is recommended that the second test should be performed 8-10°days after the first test. For transplants from deceased donors, if it is not possible to perform two tests 8-10 days apart before treatment starts (because of the timing of transplant organ availability), a pregnancy test must be performed immediately before starting treatment and a further test performed 8-10 days later.
Danish: Ved modtagelse af transplantater fra afdøde donorer, kan det på grund af tidspunktet for tilgængeligheden af transplantationsorganet, ikke altid være muligt at udføre to tests 8-10 dage efter hinanden, inden behandlingen initieres.
English: CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures by 30-50% in renal transplant patients treated with mycophenolate mofetil and CsA compared with patients receiving sirolimus or belatacept and similar doses of mycophenolate mofetil (see also section 4.4).
Danish: CsA interferer med det enterohepatiske kredsløb af MPA, resulterende i en reduceret eksponering af MPA på 30-50 % hos nyretransplanterede patienter behandlet med mycophenolatmofetil og CsA, sammenlignet med patienter behandlet med sirolimus eller belatacept og sammenlignelige doser af mycophenolatmofetil (se også pkt.
English: Pleural effusion, dyspnoea, cough
Danish: Meget almindeligAlmindelig Pleural effusion, dyspnø, hoste
English: CsA interferes with MPA enterohepatic recycling, resulting in reduced MPA exposures by 30 50% in renal transplant patients treated with mycophenolate mofetil and CsA compared with patients receiving sirolimus or belatacept and similar doses of mycophenolate mofetil (see also section 4.4).
Danish: CsA interferer med det enterohepatiske kredsløb af MPA, resulterende i en reduceret eksponering af MPA på 3050 % hos nyretransplanterede patienter behandlet med mycophenolatmofetil og CsA, sammenlignet med patienter behandlet med sirolimus eller belatacept og sammenlignelige doser af mycophenolatmofetil (se også pkt.
English: Congenital malformations have been observed post-marketing in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants, see section 4.6.
Danish: Efter markedsføring er der blevet observeret medfødte misdannelser hos børn af patienter, der har været eksponeret for mycophenolatmofetil i kombination med andre immunsuppressiva, se pkt 4.6.
English: • proliferation of the lymphatic tissue, including malignant tumours
Danish: • spredning af lymfevæv, herunder kræftsvulster.
English: If you stop taking Myfenax
Danish: Hvis du holder op med at tage Myfenax
English: As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
Danish: 4.8) end hos voksne, kan det blive nødvendigt forbigående at nedsætte dosis eller afbryde behandlingen under behørig hensyntagen til relevante kliniske faktorer, inklusive bivirkningssværhedsgraden.
English: Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
Danish: Ciclosporin's CsA farmakokinetik påvirkes ikke af mycophenolatmofetil.
English: In patients with renal impairment in whom mycophenolate mofetil and ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered the dose recommendations for ganciclovir should be observed and patients monitored carefully.
Danish: Hos patienter med nedsat nyrefunktion, som får Myfenax og ganciclovir, eller deres prodrugs, f.eks. valganciclovir, samtidig bør dosisanbefalingerne for ganciclovir følges og patienterne monitoreres omhyggeligt.
English: These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Danish: Disse infektioner er ofte forbundet med en høj samlet immunsuppressiv belastning og kan forårsage alvorlige eller dødelige tilstande.
English: The recommended dose of 1°g administered twice a day for renal transplant patients and 1.5°g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly.
Danish: Den anbefalede dosering på 1 g administreret to gange dagligt til nyretransplantationspatienter og 1,5 g administreret to gange dagligt til hjerte- eller levertransplanterede patienter er passende til ældre.
English: In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73°m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
Danish: Hos nyretransplanterede patienter med svær, kronisk nedsat nyrefunktion (glomerulær filtration < 25 ml/min/1,73 m2), bortset fra perioden den umiddelbart efter transplantionen, bør doser på mere end 1 g administreret to gange dagligt undgås.
English: Cap
Danish: Hoved
English: Myfenax should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
Danish: Myfenax må ikke anvendes hos kvinder i den fertile alder, som ikke anvender meget sikker kontraception (se pkt.
English: Package leaflet: Information for the user Myfenax 500mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Myfenax 500 filmovertrukne tabletter
English: • fit, increased tension of the muscles, shaking, sleepiness, feeling dizzy, headache, tingling, pricking or numbness
Danish: • anfald, øget muskelspænding, rysten, søvnighed, svimmelhed, hovedpine, snurren, prikken eller følelsesløshed
English: • Abnormalities of the ear (e.g. abnormally formed or absent external ear), external auditory canal atresia (middle ear);
Danish: • abnormiteter i ørerne (f.eks. abnormt formet eller manglende ydre øre), tillukning af øregangen
English: No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Danish: Dosisjusteringer er ikke nødvendigt hos nyretransplanterede patienter med svær leverparenkymlidelse.
English: This means taking 3°tablets in the morning then 3°tablets in the evening.
Danish: Det vil sige, at man skal tage 3 tabletter om morgenen og 3 tabletter om aftenen.
English: Each capsule contains 250 mg mycophenolate mofetil.
Danish: Hver kapsel indeholder 250 mg mycophenolatmofetil.
English: This means taking 6°capsules in the morning then 6°capsules in the evening.
Danish: Det vil sige, at man skal tage 6 kapsler om morgenen og 6 kapsler om aftenen.
English: No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Danish: Der foreligger ingen data for hjerte- eller levertransplanterede patienter med svær, kronisk nedsat nyrefunktion.
English: In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5°g taken twice a day [BID], morning and evening) were administered to hepatic transplant patients taking tacrolimus.
Danish: I modsætning hertil blev AUC for tacrolimus øget med ca. 20 %, når flere mycophenolatmofetil-doser (1,5 g to gange dagligt, morgen og aften) blev givet til levertransplanterede patienter, som fik tacrolimus.
English: • bowel blockage
Danish: • tarmblokering
English: Based on the results of a single dose administration study of recommended doses of oral mycophenolate mofetil and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate mofetil (see section 4.2) and ganciclovir, it is anticipated that coadministration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Danish: Baseret på resultaterne fra et studie med enkeltdosis indgift af anbefalede doser af oral mycophenolatmofetil og intravenøs ganciclovir og de kendte virkninger af nedsat nyrefunktion på mycophenolatmofetils og ganciclovirs farmakokinetik (se pkt.
English: These changes may suggest a ‘left shift' in the maturity of neutrophils in haematological investigations, which may be mistakenly interpreted as a sign of infection in immunosuppressed patients such as those that receive Myfenax.
Danish: Sådan et blodbillede kan fejlagtigt blive tolket som et tegn på infektion hos immunsupprimerede patienter, som dem der behandles med Myfenax.
English: The capsule cap is light blue opaque printed ‘M' axially in black ink.
Danish: Kapslens ”hoved” er uigennemsigtig lyseblå printet ”M” aksialt med sort blæk.
English: Reductions in pre-dose (trough) MPA concentrations of about 50% have been reported in renal transplant recipients in the days immediately following commencement of oral ciprofloxacin or amoxicillin plus clavulanic acid.
Danish: Hos nyretransplanterede patienter er der i dagene umiddelbart efter start af behandling med oral ciprofloxacin eller amoxicillin plus clavulansyre rapporteret en reduktion i præ-dosis MPA (trough) koncentrationerne på ca. 50 %.
English: Myfenax tablets should only be prescribed to patients with a body surface area greater than 1.5°m2, at a dose of 1°g twice daily (2°g daily dose).
Danish: Myfenax tabletter må kun ordineres til patienter med en legemsoverflade på mindst 1,5 m2, i en dosis på 1 g to gange dagligt (daglig dosis: 2 g).
English: Myfenax should not be given to women who are breastfeeding (see section 4.6).
Danish: Myfenax må ikke anvendes til ammende kvinder (se pkt.