FrancophonIA/ELRC3.0 huggingface dataset:
English: In the early post-transplant period (<°40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30% lower and Cmax approximately 40% lower compared to the late post-transplant period (3 - 6°months post-transplant).
Danish: I den tidlige posttransplantationsperiode (< 40 dage efter transplantationen) var den gennemsnitlige MPA AUC hos nyre-, hjerte- og levertransplanterede patienter ca. 30 % lavere og C max ca. 40 % lavere sammenlignet med den sene posttransplantationsperiode (3-6 måneder efter transplantationen).
English: • if you are allergic to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for mycophenolatmofetil, mycophenolsyre eller et af de øvrige indholdsstoffer i Myfenax (angivet i punkt 6).
English: Concomitant administration of telmisartan and mycophenolate mofetil resulted 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: Talk to your doctor or pharmacist before taking Myfenax.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Myfenax.
English: Medicinal products that affect glucuronidation (e.g. isavuconazole, telmisartan) Concomitant administration of drugs inhibiting glucuronidation of MPA may increase MPA exposure.
Danish: Lægemidler, der påvirker glukuronidation (f.eks. isavuconazol, telmisartan) Samtidig administration af lægemidler, der hæmmer glukuronidering af MPA, kan øge MPAeksponeringen.
English: Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed more capsules than you have been told to take or if you think a child has swallowed any.
Danish: Kontakt det nærmeste hospital, den nærmeste skadestue eller din læge, hvis du har slugt flere kapsler, end du har fået anvist, eller hvis du formoder, at et barn har slugt nogle af kapslerne.
English: Skin cancer, benign neoplasm of skin
Danish: Hudkræft, benignt neoplasme af huden
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 Myfenax.
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 Myfenax.
English: Myfenax is used in children and adolescents (aged 2 to 18) to prevent a body rejecting a transplanted kidney.
Danish: Myfenax anvendes til børn og unge (2-18 år) for at forhindre, at deres krop afstøder en transplanteret nyre.
English: Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid (MPA).
Danish: Mycophenolatmofetil er 2-morpholinoethyl-esteren af mycophenolsyre (MPA).
English: The risk/benefit ratio of mycophenolate mofetil in combination with sirolimus has not been established (see also section 4.5).
Danish: Risiko-/fordel forholdet ved anvendelse af mycophenolatmofetil i kombination med sirolimus er ikke blevet klarlagt (se også pkt.
English: Capsule content Pregelatinised starch (maize) Povidone K-30
Danish: Kapselindhold Pregelatineret majsstivelse Povidon K-30
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 kontraception inden behandling initieres, og vejledning omkring nødvendigheden af graviditetstests.
English: Pale purple, oval shaped film-coated tablet, debossed with "M500" on one side and plain on the other side.
Danish: Lys lilla oval formet filmovertrukken tablet præget med ”M500” på den ene side og glat på den anden side.
English: PRCA may resolve with dose reduction or cessation of Myfenax therapy.
Danish: PRCA kan forsvinde ved reduktion af dosis eller ved ophør af Myfenax-behandling.
English: • serious diseases of the bone marrow
Danish: • alvorlige sygdomme i knoglemarven
English: In patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12h) 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: 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: Do not crush the tablets.
Danish: Tabletterne må ikke knuses.
English: Myfenax film-coated tablets should be handled with care.
Danish: Myfenax filmovertrukne tabletter skal håndteres med forsigtighed.
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 neutrophilmorfologi, inklusive den erhvervede Pelger-Huet anomali, er observeret hos patienter, som er behandlet med mycophenolatmofetil.
English: Hypersensitivity reactions to Myfenax have been observed (see section 4.8).
Danish: Der er observeret overfølsomhedsreaktioner over for Myfenax (se pkt.
English: The active substance in this medicine is called mycophenolate mofetil.
Danish: Det aktive stof i denne medicin hedder mycophenolatmofetil.
English: • fluid retention in the body
Danish: • væskeophobning i kroppen
English: It is used in combination with other medicines with a similar function (i.e. ciclosporin and corticosteroids).
Danish: Det anvendes sammen med anden medicin med tilsvarende virkning (inklusive ciclosporin og binyrebarkhormon).
English: Your doctor will have to advise you what is indicated for you.
Danish: Din læge vil rådgive dig om, hvilke vacciner du må bruge.
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 overenstemmelse med bivirkninger observeret i de humane kliniske studier, som nu fremviser bivirkningsdata, der er mere relevante for en patientpopulation (se pkt.
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 non-transplant women (not taking other immunosuppressants) 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 dagligt) 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 immunsupressiva) i 3 konsekutive menstruationscykler viste ingen klinisk relevant påvirkning af mycophenolatmofetil på den ovulationshæmmende virkning af de orale kontraceptiva.
English: Following single dose administration of 1.5°g of mycophenolate mofetil to normal healthy subjects pre-treated with 4°g three times a day (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 dagligt i 4 dage var der en 40 % reduktion af MPA-AUC (se pkt.
English: Pregelatinised maize starch
Danish: Pregelatineret majsstivelse
English: • Guide for healthcare professionals
Danish: • En vejledning for sundhedspersonale
English: Do not stop taking your medicine unless your doctor tells you to.
Danish: Stop ikke med at tage din medicin, med mindre lægen har bedt dig om det.
English: Organic anion transporting polypeptides (OATPs) and multidrug resistance-associated protein 2 (MRP2) are involved in MPA's disposition; OATP isoforms, MRP2 and breast cancer resistance protein (BCRP) are transporters associated with the glucuronides' biliary excretion.
Danish: Organisk aniontransporterende polypeptider (OATP'er) og multidrug resistance protein 2 (MRP2) er involverede i fordelingen af MPA; OATP-isoformer, MRP2 og brystcancer-resistent protein er transportører som er associeret med glukoroniders galdesekretion.
English: Patients on mycophenolate mofetil who develop recurrent infections should have their serum immunoglobulins measured.
Danish: Patienter i behandling med for mycophenolatmofetil, der får tilbagevendende infektioner, skal have målt serum-immunglobuliner.
English: The recommended dose is 600°mg/m2 taken twice a day.
Danish: Den anbefalede dosis er 600 mg/m² to gange dagligt.
English: Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, Myfenax is contraindicated in breast-feeding mothers (see section 4.3).
Danish: På grund af risikoen for alvorlige bivirkninger af mycophenolatmofetil hos ammende spædbørn, er Myfenax kontraindiceret hos ammende mødre (se pkt.
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: • inflammation of the pancreas, which causes severe pain in the abdomen and back
Danish: • betændelse i bugspytkirtlen, som giver svære smerter i maven og ryggen
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 kontraception før, under og efter behandling med mycophenolatmofetil, herunder nærmere information om, hvor længe anvendelse af kontraception skal fortsætte, efter behandling er stoppet.
English: If you are a woman who could become pregnant you must use an effective method of contraception with Myfenax.
Danish: Hvis du er en kvinde og kan blive gravid, skal du bruge en effektiv præventionsmetode, mens du tager Myfenax, herunder:
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 nedsat nyrefunktion er ikke blevet undersøgt.
English: 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 post-transplant period.
Danish: værdier svarende til hos voksne, nyretransplanterede patienter, som fik mycophenolatmofetil 1 g to gange dagligt i den tidlige og sene posttransplantationsperiode.
English: pancreatitis (≥1/100 to <1/10) and intestinal villous atrophy.
Danish: pancreatitis, (≥ 1/100 til < 1/10) og intestinal villøs atrofi.
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (kan forekomme hos flere end l ud af 10 patienter)
English: • inflammation of the liver, yellowing of the skin and whites of the eyes
Danish: • leverbetændelse, gulfarvning af huden og det hvide i øjnene
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 litteraturrapporter 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: Gingival hyperplasia (≥1/100 to <1/10), colitis including cytomegalovirus colitis (≥1/100 to <1/10), pancreatitis (≥1/100 to <1/10) and intestinal villous atrophy.
Danish: Gingival hyperplasi (≥ 1/100 til <1/10), colitis inklusive cytomegalovirus colitis, (≥ 1/100 til < 1/10), pancreatitis, (≥ 1/100 til < 1/10) og intestinal villøs atrofi.
English: Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed more tablets than you have been told to take or if you think a child has swallowed any.
Danish: Kontakt det nærmeste hospital, den nærmeste skadestue eller din læge, hvis du har slugt flere tabletter end du har fået anvist, eller hvis du formoder, at et barn har slugt nogle af tabletterne.
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 bivirkninger fra erfaringer efter markedsføring De bivirkninger, som er indberettet om mycophenolatmofetil efter markedsføringen, svarer til dem, som er set i de kontrollerede kliniske nyre-, hjerte- og levertransplantationsstudier.
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: • Spontane 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: 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 MPA's Cmax og AUC - mycophenolatmofetils aktive metabolit - ikke signifikant påvirket af den samtidige administration af tacrolimus.
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 Myfenax.
Danish: Tilfælde af BK-virus associeret med nefropati såvel som tilfælde af JC-virus associeret med progessiv multifokal leukoencefalopati (PML) er blevet rapporteret hos patienter, der behandles med immunsuppressiva, herunder Myfenax.
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 mycophenolat mofetil gives samtidig med magnesium-og aluminumhydroxider, end når mycophenolat mofetil gives samtidig med protonpumpehæmmere.
English: • muscle weakness of the limbs, drooping or falling of the upper eyelid (myasthenic syndrome)
Danish: • muskelsvaghed i arme eller ben, hængende eller faldende øvre øjenlåg (myasteni-lignende syndrom)
English: The MAH shall ensure that in each MS where Myfenax is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Myfenax are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alt sundhedspersonale og patienter, som forventes at udskrive, udlevere eller anvende Myfenax, i alle medlemslande, hvor Myfenax markedsføres, har fået følgende uddannelsespakker:
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 anbefales anvender pålidelig antikonception under behandling af den mandlige patient og i mindst 90 dage efter ophør af mycophenolatmofetil.
English: • serious disease of the kidney (BK virus associated nephropathy)
Danish: • alvorlig nyresygdom (BK-virus associeret med nefropati)
English: 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: Middelværdien af MPAG-AUC efter en enkelt dosis var 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: Precautions to be taken before handling or administering the medicinal product Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myfenax tablets should not be crushed.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Da mycophenolatmofetil har udvist teratogen virkning hos rotter og kaniner, må Myfenax tabletter ikke knuses.
English: Dose adjustment of Myfenax does not appear to be necessary.
Danish: Justering af Myfenax-dosis er ikke nødvendig.
English: • serious inflammation of the membrane that covers the brain and spinal cord
Danish: • alvorlig betændelse af hinden, der dækker hjernen og rygmarven
English: Changes to Myfenax therapy should only be undertaken under appropriate supervision in transplant recipients in order to minimise the risk of graft rejection (see section 4.8).
Danish: Ændringer i behandlingen med Myfenax må kun foretages under tilstrækkelig overvågning af den transplanterede patient, så risikoen for afstødning af transplantat minimeres (se pkt.
English: • alterations of the inner wall of the small intestine (intestinal villous atrophy)
Danish: • ændringer i den indre tyndtarmsvæg (intestinal villus atrofi)
English: Precautions to be taken before handling or administering the medicinal product Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myfenax capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in Myfenax capsules.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Da mycophenolatmofetil har udvist teratogen virkning hos rotter og kaniner, må Myfenax kapsler ikke åbnes eller knuses for at undgå inhalation og undgå at hud og slimhinder kommer i direkte kontakt med pulveret i Myfenax kapslerne.
English: The first dose will be given within 5 days following the transplant operation.
Danish: Den første dosis gives inden for 5 døgn efter transplantationen.
English: • Before you start taking Myfenax
Danish: • Før du starter med at tage Myfenax
English: Caution should be used during concomitant administration because of the potential to reduce efficacy of mycophenolate mofetil.
Danish: Der skal udvises forsigtighed ved samtidig administration pga. muligheden for nedsat effekt af mycophenolatmofetil.
English: • if you experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding.
Danish: Kontakt lægen med det samme - Hvis du oplever nogen form for tegn på infektion (f.eks. feber, ondt i halsen), uventede blå mærker og/eller blødning.
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 postoperativt (se pkt.
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 bivirkninger fra de kliniske studier De vigtigste bivirkninger 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.
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 posttransplantationspatienter uden forsinket transplantatfunktion.
English: Caution should be used with medicinal products that interfere with enterohepatic circulation because of their potential to reduce the efficacy of mycophenolate mofetil.
Danish: Der skal udvises forsigtighed med lægemidler, som interfererer med den enterohepatiske cirkulation pga. risikoen for nedsat effekt af mycophenolatmofetil.
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 Blymfocytter 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: It is recommended to monitor MPA exposure levels and to adjust Myfenax doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Danish: For at opretholde den kliniske effekt bør MPA-eksponeringen overvåges, og Myfenax-doserne justeres i forhold til dette, når rifampicin administreres samtidigt.
English: Oral Myfenax should be initiated within 72°hours following transplantation.
Danish: Oralt Myfenax bør gives inden for 72 timer efter transplantation.
English: Isavuconazole An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of isavuconazole.
Danish: Isavuconazol Ved samtidig administration af isavuconazol blev der observeret en stigning i MPA AUC0-∞ med
English: The first dose of oral Myfenax will be given to you at least 4°days after the transplant operation and when you are able to swallow oral medicines.
Danish: Den første dosis Myfenax til indtagelse gennem munden gives tidligst 4 dage efter transplantationen, og når du er i stand til at indtage medicin gennem munden.
English: Do not break or crush them and do not take any capsules that have broken open or split.
Danish: Indtag ikke kapsler, der er åbnede eller gået itu.
English: • feeling restless, abnormalities of thought, perception and levels of awareness, depression, feeling anxious, abnormal thinking, difficulty in sleeping
Danish: • rastløshed, unormale tanker; opfattelse og bevidsthedsniveauer, depression, angst, abnorm tankevirksomhed, søvnbesvær
English: Contraception in men taking Myfenax
Danish: Prævention hos mænd, som tager Myfenax