FrancophonIA/ELRC3.0 huggingface dataset:
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. sirolimus, belatacept, or vice versa, as this might result in changes of MPA exposure.
Danish: Der skal udvises forsigtighed ved skift fra kombinationsbehandling indeholdende immunsupressiva som interfererer med MPAs enterohepatiske kredsløb, f.eks. ciclosporin, til andre som ikke interfererer, f.eks sirolimus, belatacept, eller omvendt, da dette kan ændre eksponeringen af MPA.
English: • Swallow your tablets whole with a glass of water.
Danish: • Synk tabletterne hele med et glas vand
English: • The first dose will be given within 3 days after the transplant operation.
Danish: • Den første dosis gives inden for 3 dage efter transplantationen.
English: Gastrointestinal and renal effects consistent with dehydration were also observed in the monkey at the highest dose (systemic exposure levels equivalent to or greater than clinical exposure).
Danish: Dehydreringslignende gastrointestinale- og nyrepåvirkninger observeredes også hos aber ved de højeste doser (systemiske niveauer lig med eller større end kliniske niveauer).
English: • A kidney, heart or liver.
Danish: • Nyre, hjerte eller lever.
English: All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4).
Danish: Alle transplanterede patienter har forhøjet risiko for opportunistiske infektioner, idet risikoen øges med stigende immunsuppressiv belastning (se pkt.
English: In experimental models, mycophenolate mofetil was not tumourigenic.
Danish: I forsøgsmodeller var mycophenolatmofetil ikke tumordannende.
English: Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with mycophenolate mofetil.
Danish: Der er observeret nedsat eksponering af MPA, når antacida, såsom magnesium-og aluminiumhydroxider, og protonpumpehæmmere, inklusive lansoprazol og pantoprazol, bliver administeret sammen med mycophenolatmofetil.
English: • Background information on mycophenolate mofetil teratogenicity and mutagenicity in humans.
Danish: • Baggrundsinformation om mycophenolatmofetils teratogenicitet og mutagenicitet hos mennesker.
English: Driving and using machines Myclausen is not likely to affect you being able to drive or use any tools or machines.
Danish: Trafik- og arbejdssikkerhed Det er ikke sandsynligt, at Myclausen påvirker din evne til at køre bil eller bruge værktøj eller maskiner.
English: As a result, your body will not be as good as normal at fighting infections.
Danish: Dette forhindrer afstødning af det transplanterede organ, men bevirker også, at din krop ikke er så god til at bekæmpe infektioner som normalt.
English: Patients should be advised that during treatment with Myclausen, 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 Myclausen kan vaccinationer være mindre effektive, og levende svækkede vacciner bør undgås (se pkt.
English: Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have been observed in patients treated with mycophenolate mofetil.
Danish: Isolerede tilfælde af abnorm neutrofil morfologi, inklusive den erhvervede Pelger-Huet anomali, er observeret hos patienter, som er behandlet med mycophenolatmofetil.
English: Therefore, the following precautionary measures are recommended: sexually active male patients or their female partners are recommended to use reliable contraception during treatment of the male patient and for at least 90 days after cessation of mycophenolate mofetil.
Danish: Derfor anbefales det som sikkerhedsforanstaltning, at sexuelt aktive mandlige patienter eller deres kvindelige partnere anvender pålidelig antikonception under behandling af den mandlige patient og i mindst 90 dage efter ophør af mycophenolatmofetil.
English: Mycophenolate mofetil is the 2-morpholinoethyl ester of MPA.
Danish: Mycophenolatmofetil er 2-morpholinoethyl-esteren af MPA.
English: Intravenous mycophenolate mofetil should be administered for the first 4 days following hepatic transplant, with oral Myclausen 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 af Myclausen påbegyndes, så snart det tåles.
English: (e.g. contraceptive methods, pregnancy testing) prior to, during, and after therapy with Myclausen.
Danish: 4.6 (f.eks. prævention, graviditetstests) før, under og efter behandling med Myclausen.
English: No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see section 5.2).
Danish: Dosisregulering er ikke nødvendig hos patienter, der oplever forsinket nyretransplantatfunktion post-operativt (se pkt.
English: Nervous system problems such as:
Danish: Lidelser i nervesystemet såsom:
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 overdosis af mycophenolatmofetil muligvis kan medføre oversuppression af immunsystemet og dermed forøge modtageligheden over for infektioner og knoglemarvsdepression (se pkt.
English: The nonclinical toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in human clinical trials which now provide safety data of more relevance to the patient population (see section 4.8).
Danish: Den ikke-kliniske toksikologiske profil af mycophenolatmofetil forekommer i overensstemmelse med bivirkninger observerede i de humane kliniske studier som nu fremviser bivirkningsdata der er mere relevante for en patientpopulation (se pkt.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.
English: Children • There is no information for the use of Myclausen in children with a heart transplant.
Danish: Børn • Der er ingen information om brug af Myclausen til hjertetransplanterede børn.
English: • Swallow your capsules whole with a glass of water.
Danish: • Synk kapslerne hele med et glas vand
English: The MAH shall ensure that in each MS where Myclausen is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Myclausen are provided with the following educational package: · Physician educational material
Danish: Markedsføringsindehaver skal sikre, at alle sundhedspersoner og patienter, som forventes at udskrive, håndtere eller anvende Myclausen, i alle medlemslande, hvor Myclausen markedsføres, har fået følgende uddannelsespakker: · Uddannelsesmateriale for sundhedspersoner · Informationsmateriale for patienter
English: In addition, the text relating to women should explain the pregnancy test requirements prior to and during therapy with mycophenolate mofetil; including the advice for two negative pregnancy tests prior to starting therapy and the importance of the timing of these tests.
Danish: Derudover skal teksten for kvinder forklare kravene om graviditetstest før og under behandling med mycophenolatmofetil, herunder vejledning om to negative graviditetstests før initiering af behandling og vigtigheden af timingen af, hvornår disse tests udføres.
English: • the amount in your blood of things like sugar, fat or cholesterol.
Danish: • mængden af f.eks. sukker, fedt eller kolesterol i blodet.
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, da pulveret i kapslerne ikke må indåndes eller komme i berøring med huden.
English: Tablet core
Danish: Tablet-kerne:
English: As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of mycophenolate mofetil is correlated with MPA concentration.
Danish: Som vist ved suppression af akut afstødning efter nyretransplantation er den immunsuppressive virkning af mycophenolatmofetil korreleret til MPA-koncentrationen.
English: However, the mean single dose MPAG AUC was 3-6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Danish: Imidlertid var middelværdien af MPAG-AUC efter en enkelt dosis 3-6 gange højere hos personer med svært nedsat nyrefunktion end hos personer med let nedsat nyrefunktion eller normale, sunde personer svarende til den kendte renale udskillelse af MPAG.
English: In vivo, MPAG is converted back to free MPA via enterohepatic recirculation.
Danish: In vivo bliver MPAG omdannet tilbage til frit MPA via det enterohepatiske kredsløb.
English: Prior to the use of Myclausen in each Member State (MS) 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, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Markedsføringsindehaver 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: The educational materials will reinforce the warnings about the teratogenicity of mycophenolate, provide advice on contraception before therapy is started and guidance on the need for pregnancy testing.
Danish: Uddannelsesmaterialet vil fremhæve advarsler vedrørende mycophenolats teratogenicitet, give vejledning om antikonception inden behandling initieres, og vejledning omkring nødvendigheden af graviditetstests.
English: Because of robust clinical evidence showing a high risk of abortion and congenital malformations when mycophenolate mofetil is used in pregnancy every effort to avoid pregnancy during treatment should be taken.
Danish: På grund af robust klinisk evidens, der viser en høj risiko for abort og medfødte misdannelser, når mycophenolatmofetil anvendes under graviditet, skal graviditet under behandlingen undgås.
English: Common Skin cancer, benign neoplasm of skin
Danish: Meget almindelig Almindelig Hudkræft, benignt neoplasme af huden
English: If you take more Myclausen than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du tager flere Myclausen, end du har fået besked på, skal du straks tale med en læge eller tage på sygehuset.
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 interfererer 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 mycophenolatmofetil (se også pkt.
English: • you have a sign of infection such as a fever or sore throat
Danish: • du har tegn på infektion, såsom feber eller ondt i halsen
English: PVC-aluminium blisters containing 10 film-coated tablets.
Danish: PVC-aluminium blisterkort indeholdende 10 filmovertrukne tabletter.
English: If you stop taking Myclausen
Danish: Hvis du holder op med at tage Myclausen
English: Concomitant administration of telmisartan and mycophenolate mofetil esulted in an approximately 30 % decrease of MPA concentrations.
Danish: Samtidig administration af telmisartan og mycophenolatmofetil resulterede i et fald i MPA koncentrationerne på ca. 30 %.
English: Patients treated with immunosuppressants, including Myclausen, 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 immunosuppressiva herunder Myclausen, er i øget risiko for opportunistiske infektioner (bakteriel, svampe, viral og protozoel), fatale infektioner og sepsis (se pkt.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Myclausen film-coated tablets should be handled with care.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Myclausen filmovertrukne tabletter skal håndteres forsigtigt.
English: The following undesirable effects cover adverse reactions from post-marketing experience The types of adverse reactions reported during post-marketing with mycophenolate mofetil are similar to those seen in the controlled renal, cardiac and hepatic transplant studies.
Danish: Følgende bivirkninger omfatter uønskede hændelser fra erfaringer efter markedsføring De uønskede hændelser, som er indberettet om mycophenolatmofetil efter markedsføringen svarer til dem, som er set i de kontrollerede kliniske nyre-, hjerte- og levertransplantationsstudier.
English: As a precaution you or your female partner are recommended to use reliable contraception during treatment and for 90 days after you stop taking Myclausen.
Danish: Som en sikkerhedsforanstaltning anbefales det, at du eller din kvindelige partner bruger pålidelig prævention under behandlingen og i 90 dage efter, at du er stoppet med at tage Myclausen.
English: • Based on literature reports, malformations occurred in 23 to 27% of live births in women exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3 % of live births in the overall population and approximately 4 to 5% of live births in solid organ transplant recipients treated with immunosuppressants other than mycophenolate mofetil).
Danish: • Baseret på litteratur rapporter forekom misdannelser hos 23 til 27% af levendefødte børn, hvor moderen var eksponeret for mycophenolatmofetil under graviditet (sammenlignet med 2 til 3% hos levendefødte børn i hele populationen og ca. 4 til 5% hos patienter, der havde gennemgået en transplantation af solide organer, og som blev behandlet med andre immunsuppressiva end mycophenolatmofetil).
English: Patients on Myclausen who develop recurrent infections should have their serum immunoglobulins measured.
Danish: Patienter i behandling med Mycophenolatmofetil, der får tilbagevendende infektioner, skal have målt serum-immunoglobuliner.
English: Children • There is no information for the use of Myclausen in children with a liver transplant.
Danish: Børn • Der er ingen information om brug af Myclausen til levertransplanterede børn.
English: Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, Myclausen is contraindicated in nursing mothers (see section 4.3).
Danish: På grund af risikoen for alvorlige bivirkninger af mycophenolatmofetil hos ammende spædbørn, er Myclausen kontraindiceret hos ammende mødre (se pkt.
English: If you forget to take Myclausen
Danish: Hvis du har glemt at tage Myclausen
English: This include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty in sleeping, pains (such as stomach, chest, joint or muscle, pain on passing urine), headache, flu symptoms and swelling.
Danish: Disse inkluderer alvorlige allergiske reaktioner (såsom anafylaksi, angioødem), feber, træthedsfornemmelse, søvnbesvær, smerter (såsom smerter i maven, brystkassen, led eller muskler, smerter ved vandladning), hovedpine, influenzasymptomer og opsvulmen.
English: In hepatic transplant patients initiated on mycophenolate mofetil and tacrolimus, the AUC and Cmax of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by coadministration with tacrolimus.
Danish: Hos levertransplanterede patienter, der indledningsvis blev behandlet med mycophenolatmofetil og tacrolimus samtidigt, blev MPAs Cmax og AUC - mycophenolatmofetils aktive metabolit - ikke signifikant påvirket af den samtidige administration af tacrolimus.
English: Two genotoxicity assays (in vitro mouse lymphoma assay and in vivo mouse bone marrow micronucleus test) showed a potential of mycophenolate mofetil to cause chromosomal aberrations.
Danish: To genotoksicitets tests (in vitro muselymfom test og in vivo museknoglemarvs-mikronucleus test) viste, at mycophenolatmofetil potentielt kan forårsage kromosomaberrationer.
English: A study of the co-administration of mycophenolate mofetil (1 g bid) and combined oral contraceptives containing ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) or gestodene (0.05 mg to 0.10 mg) conducted in 18 nontransplant women (not taking other immunosupressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of mycophenolate mofetil on the ovulation suppressing action of the oral contraceptives.
Danish: Et studie om samtidig administration af mycophenolatmofetil (1 g 2 gange daglig) og orale kontraceptiva af kombinationstypen indeholdende ethinylestradiol (0,02-0,04 mg) og levonorgestrel (0,05-0,15 mg), desogestrel (0,15 mg) eller gestoden (0,05-0,10 mg) hos 18 ikke-transplanterede kvinder (som ikke fik andre immunosuppressiva) i 3 konsekutive menstruationscykler viste ingen klinisk relevant påvirkning af mycophenolatmofetil på den ovulationshæmmende virkning af de orale kontraceptiva.
English: Mycophenolate mofetil has been shown to be excreted in the milk of lactating rats.
Danish: Det er påvist, at mycophenolatmofetil udskilles i mælken hos diegivende rotter.
English: Therefore, a change in the dose of Myclausen 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 Myclausen, hvis der ikke er klinisk evidens for dysfunktion af transplantatet.
English: In patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12 h) of 18 % to 70 %.
Danish: Hos patienter, som ikke fik ciclosporin, sås ved samtidig administration af mycophenolatmofetil og rifampicin et fald på 18-70 % i MPA-eksponeringen (AUC0-12 timer).
English: Pregnancy whilst taking mycophenolate must be avoided.
Danish: Indtagelse af mycophenolat under graviditet skal undgås.
English: Multiple dosing of mycophenolate mofetil in patients with severe chronic renal impairment has not been studied.
Danish: Indgift af flere doser af mycophenolatmofetil til patienter med svær, kronisk nyreinsufficiens er ikke blevet undersøgt.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Limited clinical evidence does not indicate an increased risk of malformations or miscarriage following paternal exposure to mycophenolate mofetil.
Danish: Begrænset klinisk evidens indikerer ikke en øget risiko for misdannelser eller abort efter faderens eksponering for mycophenolatmofetil.
English: • The first dose is given within 5 days of the transplant operation.
Danish: • Den første dosis gives inden for 5 dage efter transplantationen.
English: • Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ transplant patients treated with immunosuppressants other than mycophenolate mofetil.
Danish: • Spontante aborter er rapporteret hos 45 til 49 % af de gravide kvinder, som var eksponeret for mycophenolatmofetil, sammenlignet med en hyppighed på 12 til 33 % hos patienter , der havde gennemgået en transplantation af solide organer, og som blev behandlet med andre immunsuppressiva end mycophenolatmofetil.
English: This dose achieved MPA AUC values similar to those seen in adult renal transplant patients receiving mycophenolate mofetil at a dose of 1 g bid in the early and late posttransplant period.
Danish: Med denne dosis opnåedes MPA AUC værdier svarende til hos voksne, nyretransplanterede patienter, som fik 1 g mycophenolatmofetil to gange daglig i den tidlige og sene posttransplantationsperiode.
English: The need for contraception prior to, during and after treatment with mycophenolate mofetil, including details of the duration of time for which contraception must be continued after cessation of therapy, will be clearly stated.
Danish: Der skal være en klar beskrivelse af nødvendigheden af prævention før, under og efter behandling med mycophenolatmofetil, herunder nærmere information om, hvor længe anvendelse af prævention skal fortsætte, efter behandling er stoppet.
English: Pregnancy, puerperium and perinatal conditions Cases of spontaneous abortions have been reported in patients exposed to mycophenolate mofetil, mainly in the first trimester, see section 4.6.
Danish: Graviditet, puerperium og den perinatale periode Der er rapporteret tilfælde af spontane aborter hos patienter, som har været eksponeret for mycophenolatmofetil, hovedsagelig i første trimester, se pkt.
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, Myclausen should be administered with caution in patients with active serious digestive system disease.
Danish: Mycophenolatmofetil er blevet sat i forbindelse med en øget incidens af bivirkninger i fordøjelsessystemet inklusive sjældne tilfælde af ulceration, blødning og perforation, bør Myclausen administreres med forsigtighed til patienter med aktiv alvorlig sygdom i fordøjelsessystemet.
English: Myclausen is indicated in adults, and children and adolescents aged 2 to 18 years in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Danish: Myclausen er, i kombination med ciclosporin og kortikosteroider, indiceret hos voksne og børn og unge i alderen 2-18 år til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre-, hjerte- eller levertransplantater.
English: Each carton contains either 50 or 150 film-coated tablets.
Danish: Hver pakning indeholder enten 50 eller 150 filmovertrukne tabletter.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Myclausen capsules should be handled with care.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Myclausen kapsler skal håndteres forsigtigt.
English: Passauer Pharma GmbH Eiderstedter Weg 3 14129 Berlin Germany
Danish: Passauer Pharma GmbH Eiderstedter Weg 3 14129 Berlin Tyskland
English: Paediatric population aged 2 to 18 years The recommended dose of mycophenolate mofetil is 600 mg/m 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/m oralt to gange daglig (højst 2 g daglig).
English: The following undesirable effects cover adverse reactions from clinical trials The principal adverse reactions associated with the administration of mycophenolate mofetil in combination with ciclosporin and corticosteroids include diarrhoea, leucopenia, sepsis and vomiting, and there is evidence of a higher frequency of certain types of infections (see section 4.4).
Danish: Følgende bivirkninger omfatter uønskede hændelser fra de kliniske undersøgelser De vigtigste uønskede hændelser i forbindelse med administrationen af mycophenolatmofetil i kombination med ciclosporin og kortokosteroider omfatter diarré, leukopeni, sepsis og opkastning, og der er tegn på større hyppighed af visse typer infektioner (se pkt.