FrancophonIA/ELRC3.0 huggingface dataset:
English: • Advice that patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
Danish: • Vejledning om, at patienter ikke må være bloddonorer under behandlingen og i mindst 6 uger efter, at mycophenolat er seponeret .
English: Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for mycophenolate mofetil, mycophenolic acid the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing mycophenolate mofetil, mycophenolic acid is unchanged subject to the proposed changes to the product information
Danish: På baggrund af de videnskabelige konklusioner for mycophenolatmofetil, mycophenolsyre er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder mycophenolatmofetil, mycophenolsyre, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Marketing Authorisation Holder Passauer Pharma GmbH Eiderstedter Weg 3
Danish: Indehaver af markedsføringstilladelsen Passauer Pharma GmbH Eiderstedter Weg 3
English: • constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.
Danish: • forstoppelse, kvalme, fordøjelsesbesvær, appetitløshed, luft i maven.
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.
English: • inflammation of the pancreas, colon or stomach
Danish: • betændelse i bugspytkirtlen, tarmen eller maven
English: Common Tachycardia
Danish: Meget almindelig Almindelig Takykardi
English: • you have any unexpected bruising or bleeding
Danish: • du uden grund får blå mærker eller bløder
English: Common Pleural effusion, dyspnoea, cough
Danish: Meget almindelig Almindelig Pleural effusion, dyspnø, hoste
English: Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of Myclausen is not required.
Danish: Afstødning af nyretransplantat medfører ingen ændringer af MPA's farmakokinetik; dosisreduktion eller afbrydelse af Myclausen er ikke nødvendig.
English: Capsule shells: gelatine, titanium dioxide (E 171)
Danish: Kapselskal gelatine titandioxid (E 171)
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 bivirkningernes sværhedsgrad.
English: Congenital malformations, including reports of multiple malformations, have been observed postmarketing in children of patients exposed to Myclausen in combination with other immunosuppressants during pregnancy.
Danish: Efter markedsføring er der observeret medfødte misdannelser, herunder rapporter om multiple misdannelser hos børn af patienter, som under graviditeten var blevet behandlet med Myclausen i kombination med andre immunsuppressiva.
English: Do not break or crush the tablets.
Danish: • Du må ikke knuse eller brække kapslerne over
English: • Myclausen should not be used in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6).
Danish: • Myclausen må ikke anvendes under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet (se pkt.
English: Pregnancy, contraception and breast-feeding
Danish: Graviditet, prævention og amning
English: Ciprofloxacin and amoxicillin plus clavulanic acid 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 om en reduktion i præ-dosis- MPA (trough) koncentrationerne på ca. 50 %.
English: Sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster Common Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
Danish: Almindelig Pneumoni, influenza, infektion i luftrøret, respiratorisk moniliasis, gastrointestinal infektion, candidiasis, gastroenteritis, infektion, bronkitis, pharyngitis, sinuitis, svampeinfektion i huden, hud candidiasis, vaginal candidiasis, rhinitis
English: Hypogammaglobulinaemia has been reported in patients receiving mycophenolate mofetil in combination with other immunosuppressants (frequency not known).
Danish: Hypogammaglobulinæmi er rapporteret hos patienter, der har fået mycophenolatmofetil i kombination med andre immunsuppressiva (hyppighed ukendt).
English: • Tracheo-Oesophageal malformations (e.g. oesophageal atresia);
Danish: • trakeo-øsofageale misdannelser (f.eks. øsofagusatresi);
English: • Myclausen should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
Danish: • Myclausen må ikke anvendes hos fertile kvinder, som ikke anvender højeffektiv prævention (se ptk.
English: • Myclausen 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: • Myclausen-behandling må ikke initieres hos fertile kvinder uden at en negativ graviditetstest foreligger, for at udelukke en uønsket anvendelse under graviditet (se pkt.
English: The full name of your medicine is Myclausen 500 mg film-coated tablets.
Danish: Medicinens fulde navn er Myclausen 500 mg filmovertrukne tabletter.
English: The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by coadministration of mycophenolate mofetil (see also section 5.2).
Danish: Farmakokinetikken og farmakodynamikken af orale antikonceptionsmidler påvirkedes ikke af samtidig administration af mycophenolatmofetil (se også pkt.
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 fertile kvinder informeres om den øgede risiko for abort og medfødte misdannelser, og de skal vejledes omkring prævention og graviditetsplanlægning.
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 immunosuppressiv belastning og kan forårsage alvorlige eller fatale sygdomme.
English: Patients with a body surface area greater than 1.5 m may be prescribed Myclausen capsules at a dose of 1 g twice daily (2 g daily dose).
Danish: Patienter med en legemsoverflade over 1,5 m² kan ordineres Myclausen kapsler i en dosis på 1 g to gange daglig (daglig dosis: 2 g).
English: • antacids or proton pump inhibitors (used for acid problems in your stomach such as indigestion)
Danish: • syreneutraliserende midler eller protonpumpehæmmere (bruges mod for meget mavesyre, f.eks.
English: Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
Danish: Patienter må ikke donere blod under behandlingen og i mindst 6 uger efter seponering af mycophenolat.
English: NAME OF THE MEDICINAL PRODUCT Myclausen 250 mg hard capsules
Danish: LÆGEMIDLETS NAVN Myclausen 250 mg hårde kapsler
English: Myclausen film-coated 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: Myclausen filmovertrukne tabletter må kun ordineres til patienter med en legemsoverflade på mindst 1,5 m2, i en dosis på 1 g to gange daglig (daglig dosis: 2 g).
English: Heart transplant
Danish: Hjertetransplantation
English: No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Danish: Dosisjustering er ikke nødvendig hos nyretransplanterede patienter med svær leverparenkymlidelse.
English: There have been published reports of bronchiectasis in adults and children who received mycophenolate mofetil in combination with other immunosuppressants.
Danish: Der er publicerede tilfælde af bronkiektasi hos voksne og børn, der har fået Mycophenolatmofetil i kombination med andre immunsuppressiva.
English: • Nervous system malformations such as spina bifida;
Danish: • misdannelser i nervesystemet såsom rygmarvsbrok;
English: • If you are pregnant or planning to become pregnant or think you may be pregnant If you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
Danish: • hvis du ikke anvender effektiv prævention (se ”Graviditet, prævention og amning”)
English: Patients receiving immunosuppressive regimens involving combinations of medicinal products, including mycophenolate mofetil, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.4).
Danish: Patienter, der får immunosuppressiv behandling med kombinationer af lægemidler, inklusive mycophenolatmofetil, har forøget risiko for at udvikle lymfomer og andre maligne lidelser, især i huden (se pkt.
English: Titanium dioxide (E 171)
Danish: Gelatine, titandioxid (E 171)
English: The highest dose tested in the animal carcinogenicity studies resulted in approximately 2-3 times the systemic exposure (AUC or Cmax) observed in renal transplant patients at the recommended clinical dose of 2 g/day and 1.3-2 times the systemic exposure (AUC or Cmax) observed in cardiac transplant patients at the recommended clinical dose of 3 g/day.
Danish: Den i dyre carcinogenicitetsundersøgelser højest testede dosis resulterede i ca. 2 - 3 gange den systemiske eksponering (AUC eller Cmax), der er observeret hos nyretransplanterede patienter, der fik den anbefalede kliniske dosis på 2 g daglig og 1,3 - 2 gange den systemiske eksponering (AUC eller Cmax) observeret hos hjertetransplanterede patienter, der fik den anbefalede kliniske dosis på 3 g daglig.
English: • Take 6 capsules in the morning and then 6 capsules in the evening.
Danish: • Tag 6 kapsler om morgenen og 6 kapsler om aftenen.
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 mycophenolate mofetil.
Danish: Sådan et blodbillede kan fejlagtigt blive tolket som et tegn på infektion hos immunsupprimerede patienter, som dem der behandles med mycophenolatmofetil.
English: If you are breast-feeding.
Danish: • hvis du ammer.
English: Common Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
Danish: Opkastning, abdominalsmerter, diarré, kvalme Almindelig Gastrointestinal blødning, peritonitis, ileus, colitis, mavesår, ulcus duodeni, gastritis, oesophagitis, stomatitis, obstipation, dyspepsi, flatulens, opstød
English: The pharmacokinetics of oral contraceptives were unaffected by coadministration of mycophenolate mofetil (see also section 4.5).
Danish: Farmakokinetikken af orale kontraceptiva påvirkedes ikke af samtidig administration af mycophenolatmofetil (se også pkt.
English: The most common opportunistic infections in patients receiving mycophenolate mofetil (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/syndrome and Herpes simplex.
Danish: I kontrollerede kliniske studier hos nyre- (2 g data), hjerte- og levertransplanterede patienter, som blev fulgt i mindst 1 år, var de almindeligste opportunistiske infektioner hos patienter, som fik mycophenolatmofetil (2 g eller 3 g daglig) sammen med andre immunsupprimerende stoffer, mukokutane candidainfektioner, CMV-viræmi/syndrom og herpes simplex-infektioner.
English: Use in renal transplant
Danish: Anvendelse i forbindelse med nyretransplantation
English: Patients receiving immunosuppressive regimens involving combinations of medicinal products, including Myclausen, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8).
Danish: Patienter, der får immunosuppressiv behandling med kombinationer af lægemidler, som inkluderer Myclausen, har forøget risiko for at udvikle lymfomer og andre maligne lidelser, især i huden (se pkt.
English: Hypersensitivity reactions to mycophenolate mofetil have been observed (see section 4.8).
Danish: 6.1 Der er observeret overfølsomhedsreaktioner over for Myclausen (se pkt.
English: Based on the results of a single dose administration study of recommended doses of oral mycophenolate and IV ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate mofetil (see section 4.2) and ganciclovir, it is anticipated that co-administration 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 en undersøgelse med enkelt dosis indgift af anbefalede doser af oral mycophenolatmofetil og i.v.. ganciclovir og de kendte virkninger af nedsat nyrefunktion på mycophenolatmofetils og ganciclovirs farmakokinetik (se pkt.
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 test 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: Før Myclausen-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 mycophenolateksponering til fosteret.Det anbefales, at test nummer 2 skal udføres 8-10 dage efter den første test. 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: • Myclausen should not be given to women who are breastfeeding (see section 4.6).
Danish: • Myclausen må ikke anvendes til ammende kvinder (se pkt.
English: • Myclausen 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: • Myclausen må ikke anvendes til patienter med overfølsomhed over for mycophenolatmofetil, mycophenolsyre eller et eller flere af hjælpestofferne anført i pkt.
English: • tremor, muscle spasms, convulsions
Danish: • rysten, muskelkramper, kramper
English: anxiety, thinking abnormal, insomnia
Danish: Meget almindelig Almindelig Agitation, konfusion, depression, angst, abnorm tankevirksomhed, insomnia
English: You should check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller på apoteket, hvis der er noget, du er i tvivl om.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
English: • Take 4 capsules in the morning then 4 capsules in the evening.
Danish: • Tag 4 kapsler om morgenen og 4 kapsler om aftenen.
English: 3/µl), it may be appropriate to interrupt or discontinue Myclausen.
Danish: Myclausen måske afbrydes eller stoppes.
English: Liver transplant
Danish: Levertransplantation
English: No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Danish: Der findes ingen tilgængelige data for hjerte- eller levertransplanterede patienter med svær, kronisk nedsat nyrefunktion.
English: The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Danish: Den anbefalede dosis til nyretransplanterede patienter er 1 g administreret to gange daglig (daglig dosis: 2 g).
English: There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving mycophenolate mofetil in combination with other immunosuppressants.
Danish: Der er rapporteret hypogammaglobulinæmi i forbindelse med tilbagevendende infektioner hos patienter, der har fået Mycophenolatmofetil i kombination med andre immunsuppressiva.
English: Other adverse reactions
Danish: Andre uønskede hændelser
English: When comparing rates of transplant rejection or rates of graft loss between mycophenolate mofetil patients taking PPIs versus mycophenolate mofetil patients not taking PPIs, no significant differences were seen.
Danish: Der blev ikke set signifikante forskelle i hyppigheden af afstødning eller tab af transplantat hos mycophenolatmofetil-patienter, som tog protonpumpehæmmer versus mycophenolatmofetil-patienter, som ikke tog protonpumpehæmmer.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Myclausen Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Delayed renal graft function
Danish: Forsinket renal transplantatfunktion
English: • The first dose of oral Myclausen will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medications.
Danish: • Du får tidligst den første dosis Myclausen til indtagelse gennem munden 4 dage efter transplantationen.
English: Therefore women with childbearing potential must use at least one form of reliable contraception (see section 4.3) before starting Myclausen therapy, during therapy, and for six weeks after stopping the therapy; unless abstinence is the chosen method of contraception.
Danish: 4.3), inden behandling med Myclausen påbegyndes, under behandlingen og i seks uger efter behandlingsophør, medmindre seksuel afholdenhed er den valgte form for prævention.
English: At clinically encountered concentrations, MPA and MPAG are not removed by haemodialysis.
Danish: MPA og MPAG i kliniske koncentrationer fjernes ikke ved hæmodialyse.
English: Cholestyramine
Danish: Colestyramin
English: NAME OF THE MEDICINAL PRODUCT Myclausen 250 mg hard capsules Mycophenolate mofetil
Danish: LÆGEMIDLETS NAVN Myclausen 250 mg hårde kapsler Mycophenolatmofetil
English: Capsule content Pregelatinised starch (maize) Croscarmellose sodium Povidone (K-30) Magnesium stearate
Danish: Kapselindhold prægelatineret stivelse (majs) croscarmellosenatrium povidon (K-30) magnesiumstearat
English: In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (including anophthalmia, agnathia, and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
Danish: I en undersøgelse af fertilitet og reproduktion udført på hunrotter forårsagede orale doser på 4,5 mg/kg/dag misdannelser (inkl.
English: Microcrystalline cellulose Povidone (K-30) Croscarmellose sodium Magnesium stearate
Danish: Tablet-kerne mikrokrystallinsk cellulose povidon (K-30) croscarmellosenatrium magnesiumstearat
English: Furthermore, men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate.
Danish: Ydermere, at mænd ikke må være sæddonorer under behandlingen og i 90 dage efter, at mycophenolat er seponeret.
English: It may harm them,
Danish: ved fordøjelsesbesvær)
English: This includes: Before you start taking Myclausen During your entire treatment with Myclausen For 6 weeks after you stop taking Myclausen.
Danish: • I 6 uger efter du er stoppet med at tage Myclausen.
English: Myclausen 500 mg film-coated tablets Mycophenolate mofetil
Danish: Myclausen 500 mg filmovertrukne tabletter Mycophenolatmofetil
English: NAME OF THE MEDICINAL PRODUCT Myclausen 500 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Myclausen 500 mg filmovertrukne tabletter
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leucoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including mycophenolate mofetil. Agranulocytosis (≥ 1/1000 to < 1/100) and neutropenia have been reported; therefore, regular monitoring of patients taking Myclausen is advised (see section 4.4).
Danish: Tilfælde af BK-virus associeret med nefropati såvel som tilfælde af JC-virus associeret med progressiv multifokal leukoencefalopati (PML) er blevet rapporteret hos patienter, der behandles med immunosuppressiva herunder mycophenolatmofetil.
English: When comparing rates of transplant rejection, rates of graft loss or adverse event profiles between mycophenolate mofetil patients with and without concomitant telmisartan medication, no clinical consequences of the pharmacokinetic medicinal product-medicinal product interaction were seen.
Danish: Der blev ikke set kliniske konsekvenser af de farmakokinetiske lægemiddelinteraktioner ved sammenligning af hyppigheden af afstødning af transplantat eller tab af transplantat eller bivirkningsprofilen mellem mycophenolatmofetil-patienter med og uden samtidig telmisartan-medicinering.
English: The systemic exposure at these levels is approximately equivalent to or less than 0.5 times the clinical exposure at the recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3 times the clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients (see section 4.6).
Danish: Den systemiske eksponering på disse niveauer er omtrent lig med eller mindre end 0,5 gange den kliniske eksponering ved den anbefalede dosis på 2 g daglig til nyretransplanterede patienter og ca. 0,3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g daglig til hjertetransplanterede patienter (se pkt.
English: The systemic exposure at this dose represents 2-3 times the clinical exposure at the recommended clinical dose of 2 g/day in renal transplant patients and 1.3-2 times the clinical exposure at the recommended clinical dose of 3 g/day in cardiac transplant patients.
Danish: Den systemiske eksponering af denne dosis repræsenterer 2-3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 2 g daglig til nyretransplanterede patienter og 1,3 - 2 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g daglig til hjertetransplanterede patienter.
English: Skin problems such as: • acne, cold sores, shingles, skin growth, hair loss, rash, itching.
Danish: Hudlidelser såsom: • akne, forkølelsessår, helvedesild (herpes zoster), øget hudvækst, hårtab, udslæt, kløe.
English: Kidney transplant
Danish: Nyretransplantation
English: Antacids and proton pump inhibitors (PPIs)
Danish: Antacida og protonpumpehæmmere
English: Myclausen 250 mg hard capsules Mycophenolate mofetil
Danish: Myclausen 250 mg håde kapsler Mycophenolatmofetil
English: The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
Danish: Den anbefalede dosis til hjertetransplanterede patienter er 1,5 g administreret to gange daglig (daglig dosis: 3 g).