FrancophonIA/ELRC3.0 huggingface dataset:
English: In contrast, there was an increase of approximately 20 % in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5 g BID) 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 daglig) blev givet til levertransplanterede patienter, som fik tacrolimus.
English: Myclausen 250 mg capsules is available PVC-aluminium blister containing 10 capsules.
Danish: Myclausen 250 mg kapsler leveres i PVC-aluminium blisterkort indeholdende 10 kapsler.
English: Mean plasma MPAG AUC (0-12 h) was 2-3-fold higher than in post-transplant patients without delayed graft function.
Danish: Middelværdien for plasma-MPAG AUC0-12 timer var 2-3 gange højere end hos post-transplantationspatienter uden forsinket transplantatfunktion.
English: If you are a woman who could become pregnant, you must provide a negative pregnancy test before starting treatment and must follow the contraception advice given to you by your doctor.
Danish: Hvis du er kvinde og kan blive gravid, skal der foreligge en negativ graviditetstest, før du må påbegynde behandlingen, og du skal følge lægens råd om prævention.
English: Because T and B lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells.
Danish: Da T- og B-lymfocytter i deres proliferation, i modsætning til andre celletyper, der kan anvende alternative veje, er helt afhængige af en de novo-syntese af puriner, har MPA en mere potent cytostatisk virkning på lymfocytter end på andre celler.
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: Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 years) given 600 mg/m mycophenolate mofetil orally twice daily.
Danish: Farmakokinetiske parametre evalueredes hos 49 nyretransplanterede børn (2-18 år), som fik 600 mg/m mycophenolatmofetil oralt to gange daglig.
English: Mycophenolate is a powerful human teratogen.
Danish: Mycophenolat har en potent teratogen virkning hos mennesker.
English: Take care not to let any powder from inside a broken capsule get onto your skin.
Danish: Undgå at pulver fra itugående kapsler kommer i kontakt med din hud.
English: There have also been isolated reports of interstitial lung disease and pulmonary fibrosis, some of which were fatal (see section 4.8).
Danish: Der er også rapporteret enkelte tilfælde af interstitiel lungesygdom og lungefibrose, som i nogle tilfælde var dødelige (se pkt.
English: Lung problems such as:
Danish: Hudlidelser såsom:
English: It is recommended to monitor MPA exposure levels and to adjust Myclausen doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Danish: For at opretholde den kliniske effekt bør MPA-eksponeringen overvåges, og Myclausen-doserne justeres i forhold til dette, når rifampicin administreres samtidigt.
English: Medicinal products of other classes which interfere with MPA's enterohepatic cycle e.g. cholestyramine should be used with caution due to their potential to reduce the plasma levels and efficacy of Myclausen (see also section 4.5).
Danish: Lægemidler af andre grupper som påvirker MPAs enterohepatiske kredsløb, f.eks. colestyramin, bør anvendes med forsigtighed, da de potentielt kan reducere plasmaniveauet og virkningen af Myclausen (se også pkt.
English: INFORMATION IN BRAILLE Myclausen 500 mg
Danish: INFORMATION I BRAILLE-SKRIFT Myclausen 500 mg
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: Therefore Myclausen is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection.
Danish: Derfor er Myclausen kontraindiceret under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet.
English: Tel.: 0049 (0)30 744 60 12 Fax: 0049 (0)30 744 60 41
Danish: Tlf.: 0049 (0)30 744 60 12 Fax: 0049 (0)30 744 60 41
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: Dose adjustment of Myclausen does not appear to be necessary.
Danish: Justering af Myclausen-dosis er ikke nødvendig.
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 middel MPAAUC0-12 timer sammenlignelig med, hvad man så hos posttransplantations-patienter uden forsinket transplantatfunktion.
English: INFORMATION IN BRAILLE Myclausen 250 mg
Danish: INFORMATION I BRAILLE-SKRIFT Myclausen 250 mg
English: Female patients of childbearing potential should be made aware of the risks and follow the recommendations provided in section 4.6.
Danish: Kvinder i den fertile alder skal informeres om risici og følge anbefalingerne angivet under pkt.
English: These data support extrapolation of this finding to all antacids because the reduction in exposure when mycophenolate mofetil was co- administered with magnesium and aluminium hydroxides is considerably less than when mycophenolate mofetil was co-administered with PPIs.
Danish: Disse data supporterer ekstrapolering af dette fund til alle antacida, fordi reduktionen i eksponering er betydelig mindre, når mycophenolatmofetil gives samtidig med magnesium-og aluminumhydroxider, end når mycophenolatmofetil gives samtidig med protonpumpehæmmere.
English: • If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients in this medicine (listed in section 6).
Danish: • hvis du er allergisk (overfølsom) over for mycophenolatmofetil, mycophenolsyre eller et af de øvrige indholdsstoffer i lægemidlet (angivet i punkt 6)
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 umiddelbart efter transplantationen, bør doser på mere end 1 g administreret to gange daglig undgås.
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 daglig til nyretransplanterede patienter og 1,5 g administreret to gange daglig til hjerte- eller levertransplanterede patienter er passende til ældre.
English: In addition, a pregnancy follow-up questionnaire including details of exposure during pregnancy, including timing and dose; duration of therapy, before and during pregnancy; concomitant drugs; known teratogenic risks and full details of congenital malformations should be agreed to with the national competent authorities and implemented within four months after completion of this procedure.
Danish: Spørgeskemaet skal indeholde fyldestgørende oplysninger om eksponering under graviditet, herunder tidsangivelse og dosis; behandlingsvarighed før og under graviditet; lægemidler, som har været anvendt samtidig; kendte teratogene risici og fyldestgørende oplysninger om medfødte misdannelser.
English: Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
Danish: Ciclosporin's (CsA) farmakokinetik påvirkes ikke af mycophenolatmofetil.
English: Co-administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of MPAG by 3-fold.
Danish: Samtidig administration af probenecid og mycophenolatmofetil forhøjer MPAG's plasma AUC 3 gange hos aber.
English: Neoplasms
Danish: Neoplasmer
English: Contraception (see section 4.6)
Danish: Antikonception (se pkt.
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: Uønskede hændelser, 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: Tablet coat: Polyvinyl alcohol (partially hydrolysed), titanium dioxide (E 171) macrogol 3000,talc
Danish: Tablet-overtræk: Polyvinylalkohol (delvist hydrolyseret), titandioxid (E 171), macrogol 3000, talkum
English: Oral Myclausen should be initiated within 5 days following transplantation.
Danish: Behandling med oralt Myclausen bør påbegyndes inden for 5 dage efter transplantation.
English: Mycophenolate mofetil is an IMPDH (inosine monophosphate dehydrogenase) inhibitor.
Danish: Mycophenolatmofetil er en IMPDH-hæmmer (inosinmonofosfatdehydrogenase-hæmmer).
English: Common Hepatitis, jaundice, hyperbilirubinaemia
Danish: Meget almindelig Almindelig Hepatitis, icterus, hyperbilirubinæmi
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 daglig til nyretransplanterede patienter.
English: This includes medicines obtained without a prescription, including herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept f.eks. naturlægemidler og vitaminer og mineraler.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: ANVENDT LÆGEMIDDEL SAMT AFFALD HERAF Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer
English: Male patients of reproductive potential should be made aware of and discuss the potential risk 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: Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40 % reduction in the AUC of MPA (see section 4.4 and section 5.2).
Danish: Efter enkeltdosis-administration af 1,5 g mycophenolatmofetil til normale, sunde personer forbehandlet med 4 g colestyramin tre gange daglig i 4 dage var der en 40 % reduktion af MPA AUC (se pkt.
English: Myclausen 500 mg film-coated tablets are available in PVC-aluminium blisters containing 10 tablets.
Danish: Myclausen 500 mg filmovertrukne tabletter leveres i PVC-aluminium blisterkort indeholdende 10 tabletter.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Passauer Pharma GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Passauer Pharma GmbH
English: • Take 2 tablets in the morning then 2 tablets in the evening.
Danish: • Tag 2 tabletter om morgenen og 2 tabletter om aftenen.
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 en enkelt-dosis undersøgelse (6 personer per gruppe) blev middelværdi for plasma MPA-AUC hos personer med svær, kronisk nedsat nyrefunktion (glomerulær filtrationsrate < 25 ml/min/1,73 m observeret til 28-75 % højere i forhold til middelværdierne hos normale, sunde personer eller personer med let nedsat nyrefunktion.
English: Myclausen contains mycophenolate mofetil.
Danish: Myclausen indeholder mycophenolatmofetil.
English: They should not be opened or crushed.
Danish: • De må ikke brækkes over eller knuses.
English: What you need to know before you take Myclausen
Danish: Det skal du vide, før du begynder at tage Myclausen
English: Taking into account the PRAC Assessment Report on the PSUR(s) for mycophenolate mofetil, mycophenolic acid, the scientific conclusions of CHMP are as follows: Following a review of all available information regarding pregnancies following paternal exposure to mycophenolate mofetil or mycophenolic acid, including a review of all nonclinical data and information on transmission of mycophenolic acid via the semen, the PRAC concluded that the data does not highlight any patterns or an increase in congenital malformations or spontaneous abortions.
Danish: Efter en gennemgang af tilgængelig information om graviditet, efter faderen er blevet eksponeret for mycophenolatmofetil eller mycophenolsyre, herunder en gennemgang af alle ikke-kliniske data og information om overførsel af mycophenolsyre via sæden, konkluderede PRAC, at data ikke viser nogen mønstre eller en stigning i medfødte misdannelser eller spontane aborter.
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 MPAs AUC på ca. 30 % forventes, hvis samtidig ciclosporinbehandling seponeres.
English: Elderly patients receiving mycophenolate mofetil as part of a combination immunosuppressive regimen, may be at increased risk of certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger individuals.
Danish: Ældre patienter, som får mycophenolatmofetil som led i et immunsuppressivt kombinationsregime, kan have større risiko for visse infektioner (inklusive vævsinvasiv sygdom forårsaget af cytomegalovirus) og muligvis gastrointestinal blødning og lungeødem sammenlignet med yngre individer.
English: White round film-coated tablets.
Danish: Hvide, runde, filmovertrukne tabletter.
English: Very common Common Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased 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: Meget almindelig Almindelig Forhøjede leverenzymer, forhøjet serum-creatinin, forhøjet laktatdehydrogenase, forhøjet serum-carbamid, forhøjede basiske fosfataser, vægttab Note: 501 (2 g mycophenolatmofetil daglig), 289 (3 g mycophenolatmofetil dagligt) og 277 (2 g intravenøst/ 3 g oral mycophenolatmofetil dagligt) patienter i fase III studier blev behandlet med henblik på forebyggelse af afstødelse efter henholdsvis nyre-, hjerte- og levertransplantation.
English: Very common Common Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
Danish: Meget almindelig Almindelig Acidose, hyperkaliæmi, hypokaliæmi, hyperglykæmi, hypomagnesæmi, hypokalcæmi, hyperkolesterolæmi, hyperlipæmi, hypofosfatæmi, hyperurikæmi, arthritis urica, anoreksi
English: • An introduction in each guide will inform the reader that the purpose of the guide is to tell them that a foetal exposure must be avoided and how to minimize the risk of birth defects and miscarriage associated with mycophenolate mofetil.
Danish: • Introduktionen til vejledningerne skal informere læseren om, at formålet med vejledningen er at informere om, at føtal eksponering skal undgås.
English: Always take Myclausen exactly as your doctor has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens anvisning.
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 fatale.
English: Three-year safety data in renal and cardiac transplant patients did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data.
Danish: Sammenlignet med data efter 1 år viste sikkerhedsdata for 3 år ingen uventede ændringer mht. hyppighed af malignitet hos nyre- og hjertetransplanterede patienter.
English: Method of administration
Danish: Administration Oral administration
English: Other problems such as: • weight loss, gout, high blood sugar, bleeding, bruising.
Danish: Andre lidelser såsom: • vægttab, urinsyregigt, forhøjet blodsukker, blødning, blå mærker.
English: Paediatric population No data are available for paediatric hepatic transplant patients.
Danish: Pædiatrisk population Der er ingen tilgængelige data vedrørende levertransplantationer hos pædiatriske patienter.
English: The risk/benefit ratio of mycophenolate mofetil in combination with tacrolimus or sirolimus has not been established (see also section 4.5).
Danish: Risiko/-fordel forholdet ved anvendelse af mycophenolatmofetil i kombination med tacrolimus eller sirolimus er ikke blevet klarlagt (se også pkt.
English: The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18 years who were given 600 mg/m mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g mycophenolate mofetil twice daily.
Danish: I et klinisk studie, som rekrutterede 92 børn i alderen 2-18 år, og som fik 600 mg/m mycophenolatmofetil oralt to gange daglig, var typen og hyppigheden af uønskede hændelser generelt den samme som dem, der observeredes hos voksne patienter, som fik 1 g mycophenolatmofetil to gange dagligt.
English: Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myclausen film-coated tablets should not be broken or crushed.
Danish: Da mycophenolatmofetil har udvist teratogen virkning hos rotter og kaniner, må Myclausen kapsler ikke åbnes eller knuses.
English: Polyvinyl alcohol (partially hydrolysed) Titanium dioxide (E 171) Macrogol 3000
Danish: Tablet-overtræk polyvinylalkohol (delvist hydrolyseret) titandioxid (E 171) macrogol 3000 talkum
English: You must not donate blood during treatment with Myclausen and for at least 6 weeks after stopping treatment.
Danish: Du må ikke give blod under behandling med Myclausen og i mindst 6 uger efter behandlingens ophør.
English: • If you have any unexpected bruising or bleeding
Danish: • hvis du uden grund får blå mærker eller bløder
English: Adverse reactions, reported in patients treated with mycophenolate mofetil in renal, cardiac and hepatic clinical trials when used in combination with ciclosporin and corticosteroids
Danish: Uønskede hændelser, der rapporteredes hos patienter, som blev behandlet med mycophenolatmofetil i kombination med ciclosporin og kortikosteroider i de kliniske nyre-, hjerte- og leverstudier
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 ryggraden (spina bifida).
English: White oblong capsules.
Danish: Hvide, aflange kapsler.
English: Men must not donate semen during treatment with Myclausen and for at least 90 days after stopping treatment.
Danish: Mænd må ikke være sæddonorer under behandling med Myclausen og i mindst 90 dage efter behandlingens ophør.
English: No pharmacokinetic data are available during hepatic transplant rejection.
Danish: Der findes ingen farmakokinetiske data for afstødning af levertransplantat.
English: • Take 3 tablets in the morning and then 3 tablets in the evening.
Danish: • Tag 3 tabletter om morgenen og 3 tabletter om aftenen.
English: PHARMACEUTICAL FORM AND CONTENTS 50 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 50 filmovertrukne tabletter
English: • Abnormalities of the ear (e.g. abnormally formed or absent external ear), external auditory canal artesia (middle ear);
Danish: • abnormiteter i ørerne (f.eks. abnormt formet eller manglende ydre øre), tillukning af øregangen
English: Common Skin hypertrophy, rash, acne, alopecia
Danish: Meget almindelig Almindelig Hud hypertrofi, udslæt, acne, alopeci
English: Elderly patients may be at an increased risk of adverse events such as certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared with younger individuals (see section 4.8).
Danish: Ældre patienter kan have større risiko for bivirkninger, såsom visse infektioner (inklusiv vævsinvasiv sygdom forårsaget af cytomegalovirus) og muligvis gastrointestinal blødning og lungeødem, sammenlignet med yngre patienter (se pkt.
English: PHARMACEUTICAL FORM AND CONTENTS 150 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 150 filmovertrukne tabletter
English: However, in renal transplant patients, tacrolimus concentration did not appear to be altered by mycophenolate mofetil (see also section 4.4).
Danish: Hos nyretransplanterede patienter blev tacrolimuskoncentrationen imidlertid tilsyneladende ikke påvirket af mycophenolatmofetil (se også pkt.
English: Urinary problems such as: • kidney problems or the urgent need to pass water (urine).
Danish: Urinvejslidelser såsom: • nyreproblemer eller akut vandladningstrang.
English: Use in cardiac transplant
Danish: Anvendelse i forbindelse med hjertetransplantation
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Danish: GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel
English: The full name of your medicine is Myclausen 250 mg hard capsules.
Danish: Medicinens fulde navn er Myclausen 250 mg hårde kapsler.
English: Bile acid sequestrants, such as cholestyramine, can remove MPA by decreasing the enterohepatic recirculation of the drug (see section 5.2).
Danish: Galdesyrebindende stoffer, som colestyramin, kan fjerne MPA ved at nedsætte den enterohepatiske recirkulation af stoffet (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 immunosuppressiva.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/003 (100 hard capsules)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/647/003 (100 hårde kapsler)