natgillin/translations-raw huggingface dataset:
I modsætning hertil blev AUC for tacrolimus øget med ca. 20 %, når flere mycophenolatmofetil-doser (1,5 g to gange dagligt, morgen og aften) blev givet til levertransplanterede patienter, som fik tacrolimus. 
In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5°g taken twice a day [BID], morning and evening) were administered to hepatic transplant patients taking tacrolimus.
• tarmblokering 
• bowel blockage
Baseret på resultaterne fra et studie med enkeltdosis indgift af anbefalede doser af oral mycophenolatmofetil og intravenøs ganciclovir og de kendte virkninger af nedsat nyrefunktion på mycophenolatmofetils og ganciclovirs farmakokinetik (se pkt. 
Based on the results of a single dose administration study of recommended doses of oral mycophenolate mofetil and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate mofetil (see section 4.2) and ganciclovir, it is anticipated that coadministration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Sådan et blodbillede kan fejlagtigt blive tolket som et tegn på infektion hos immunsupprimerede patienter, som dem der behandles med Myfenax. 
These changes may suggest a ‘left shift' in the maturity of neutrophils in haematological investigations, which may be mistakenly interpreted as a sign of infection in immunosuppressed patients such as those that receive Myfenax.
Kapslens ”hoved” er uigennemsigtig lyseblå printet ”M” aksialt med sort blæk. 
The capsule cap is light blue opaque printed ‘M' axially in black ink.
Hos nyretransplanterede patienter er der i dagene umiddelbart efter start af behandling med oral ciprofloxacin eller amoxicillin plus clavulansyre rapporteret en reduktion i præ-dosis MPA (trough) koncentrationerne på ca. 50 %. 
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.
Myfenax tabletter må kun ordineres til patienter med en legemsoverflade på mindst 1,5 m2, i en dosis på 1 g to gange dagligt (daglig dosis: 2 g). 
Myfenax tablets should only be prescribed to patients with a body surface area greater than 1.5°m2, at a dose of 1°g twice daily (2°g daily dose).
Myfenax må ikke anvendes til ammende kvinder (se pkt. 
Myfenax should not be given to women who are breastfeeding (see section 4.6).
Hjertetransplantation 
Heart Transplant
• opkastning, mavesmerter, diarré, kvalme 
• vomiting, stomach pain, diarrhoea, feeling sick
Myfenax 500 mg filmovertrukket tabletter fås i PVC/PVdC-aluminium blistre i pakningstørrelser på 50 og 150 eller 50x1 tabletter pr. karton. 
Myfenax 500 mg film-coated tablets are available in PVC/PVdC-aluminium blisters in pack sizes of 50 or 150 or 50 x 1 tablets per carton.
Brug af anden medicin sammen med Myfenax 
Other medicines and Myfenax
Der er publicerede tilfælde af bronkiektasi hos voksne og børn, der har fået for mycophenolatmofetil i kombination med andre immunsuppressiva. 
There have been published reports of bronchiectasis in adults and children who received mycophenolate mofetil in combination with other immunosuppressants.
I kontrollerede kliniske studier hos nyre- (2 g data), hjerte- og levertransplantationspatienter, som blev fulgt i mindst 1 år, var de almindeligste opportunistiske infektioner hos patienter, som fik mycophenolatmofetil (2 g eller 3 g dagligt) sammen med andre immunsupprimerende stoffer, mukokutane candidainfektioner, cytomegalovirus (CMV) viræmi/syndrom og herpes simplex infektioner. 
The most common opportunistic infections in patients receiving mycophenolate mofetil (2°g or 3°g daily) with other immunosuppressants in controlled clinical trials in renal (2°g data), cardiac and hepatic transplant patients followed for at least 1°year were candida mucocutaneous, cytomegalovirus (CMV) viraemia/syndrome and Herpes simplex.
Mænd må ikke være sæddonorer under behandling med Myfenax og i mindst 90 dage efter behandlingens ophør. 
Men must not donate semen during treatment with Myfenax and for at least 90°days after stopping treatment.
Sort blæk indeholder: Sort jernoxid (E172), propylenglycol og kaliumhydroxid 
Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide
Myfenax må ikke anvendes under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet (se pkt. 
Myfenax should not be used during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6).
Ældre patienter, som får Myfenax som led i et immunsuppressivt kombinationsregime, kan have større risiko for bivirkninger, såsom visse infektioner (inklusive vævsinvasiv sygdom forårsaget af cytomegalovirus) og muligvis gastrointestinal blødning og lungeødem sammenlignet med yngre individer. 
Elderly patients receiving Myfenax 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.
- Hvis du ammer. 
• if you are breast-feeding.
Krop: er uigennemsigtig karamelfarvet printet ”250” aksialt med sort blæk. 
Body: caramel opaque, printed ‘250' axially in black ink.
Til patienter med en legemsoverflade > 1,5 m2 kan der ordineres Myfenax-kapsler i en dosis på 1 g to gange dagligt (daglig dosis: 2 g). 
Patients with a body surface area greater than 1.5 m2 may be prescribed Myfenax capsules at a dose of 1 g twice daily (2 g daily dose).
Transparent PVC/PVdC-aluminium blister i pakningsstørrelser af 100 eller 300 eller 100x1 kapsler pr. karton. 
Transparent PVC/PVdC - aluminium blisters in pack sizes of 100 or 300 or 100 x 1 capsules per carton.
Transparent PVC/PVdC-aluminium blister i pakningsstørrelser af 50 eller 150 eller 50x1 tabletter pr. karton. 
Transparent PVC/PVdC-aluminium blisters in pack sizes of 50 or 150 or 50 x 1 tablets per carton.
For at udelukke en uønsket anvendelse under graviditet må behandling ikke initieres, uden at en negativ graviditetstest foreligger. 
Treatment should not be initiated without providing a negative pregnancy test result to rule out unintended use in pregnancy.
Myfenax 500 mg filmovertrukne tabletter 
Myfenax 500 mg Film-coated Tablets
Myfenax 250 mg kapsler, hårde fås i PVC/PVdC-aluminium blister i pakningsstørrelser på 100 eller 300 eller 100x1 kapsler pr. karton. 
Myfenax 250 mg hard capsules are available in PVC/PVdC-aluminium blisters in pack sizes of 100 or 300 or 100 x 1 capsules per carton.
Myfenax 250 mg kapsler, hårde Mycophenolatmofetil 
Myfenax 250mg hard capsules Mycophenolate mofetil
Efter markedsføring er der observeret medfødte misdannelser, herunder rapporter om multiple misdannelser hos børn af patienter, som under graviditeten var blevet behandlet med mycophenolat i kombination med andre immunsuppressiva. 
Congenital malformations, including reports of multiple malformations, have been observed postmarketing in children of patients exposed to mycophenolate in combination with other immunosuppressants during pregnancy.
Du må ikke give blod under behandling med Myfenax og i mindst 6 uger efter behandlingens ophør. 
You must not donate blood during treatment with Myfenax and for at least 6 weeks after stopping treatment.
Farmakokinetikken af orale kontraceptiva påvirkedes ikke af samtidig administration af mycophenolatmofetil (se også pkt. 
The pharmacokinetics of oral contraceptives were unaffected by co-administration of mycophenolate mofetil (see also section 4.5).
• forstoppelse, fordøjelsesbesvær, luft i maven (flatulens), bøvsen 
• constipation, indigestion, wind (flatulence), belching
Det skal du vide, før du begynder at tage Myfenax 
What you need to know before you take Myfenax
Når mycophenolatmofetil blev administreret samtidig med sevelamer, faldt MPA- Cmax og AUC0-12 timer med henholdsvis 30 % og 25 %, dog uden at dette havde kliniske konsekvenser (f.eks. i form af transplantatafstødning). 
Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i.e. graft rejection).
Levertransplantation 
Liver Transplant
Det vil sige, at man skal tage 4 kapsler om morgenen og 4 kapsler om aftenen. 
This means taking 4 capsules in the morning then 4 capsules in the evening.
I et studie af fertilitet og reproduktion udført på hunrotter forårsagede orale doser på 4.5 mg/kg/dag misdannelser (inkl. 
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.
Der er rapporteret hypogammaglobulinæmi i forbindelse med tilbagevendende infektioner hos patienter, der har fået for mycophenolatmofetil i kombination med andre immunsuppressiva. 
There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving mycophenolate mofetil in combination with other immunosuppressants.
Kapsler, hårde 
Hard capsules
Den i dyre carcinogenicitetsstudier højest testede dosis resulterede i ca. 2-3 gange den systemiske eksponering (AUC eller Cmax) der er observeret hos nyre transplantationspatienter der fik den anbefalede kliniske dosis på 2 g dagligt og 1,3-2 gange den systemiske eksponering (AUC eller Cmax) observeret hos hjertetransplantationspatienter, der fik den anbefalede kliniske dosis på 3 g dagligt. 
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.
Vejledning om, at patienter ikke må være bloddonorer under behandlingen og i mindst 6 uger efter, at mycophenolat er seponeret. 
Advice that patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
• ændringer i smagssansen 
• distortion of the sense of taste
Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. hårde kapsel, dvs. det er i det væsentlige natrium-frit. 
This medicinal product contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
Lægen skal give kvinder i den fertile alder og fertile mænd, når det er relevant, udførlig patientinformation om de teratogene risici og forholdsregler til at forebygge graviditet. 
Full patient information about the teratogenic risk and the pregnancy prevention measures should be given by the physician to women of childbearing potential and, as appropriate, to male patients.
Myfenax 500 mg filmovertrukne tabletter Mycophenolatmofetil 
Myfenax 500 mg film-coated tablets Mycophenolate mofetil
Meget almindeligAlmindelig Acidose, hyperkaliæmi, hypokaliæmi, hyperglykæmi, hypomagnesæmi, hypokalcæmi, hyperkolesterolæmi, hyperlipæmi, hypofosfatæmi, hyperurikæmi, arthritis urica, anoreksi Psykiske forstyrrelser Meget almindeligAlmindelig Agitation, konfusion, depression, angst, abnorm tankevirksomhed, insomnia 
Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia Psychiatric disorders Very commonCommon
Patienten må ikke donere blod under behandlingen og i mindst 6 uger efter seponering af mycophenolat. 
Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
Indigocarmin (E 132) Jernoxid, sort (E172) Jernoxid, rød (E172) 
Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
• hurtigere hjerteslag 
• faster heart beat
4.6 (f.eks. prævention, graviditetstests) før, under og efter behandling med mycophenolat. 
Female patients of childbearing potential should be made aware of the risks and follow the recommendations provided in section 4.6 (e.g. contraceptive methods, pregnancy testing) prior to, during, and after therapy with mycophenolate.
Hoved: er uigennemsigtig lyseblå printet ”M” aksialt med sort blæk. 
Cap: light blue opaque printed ‘M' axially in black ink.
• bronkitis, ondt i halsen, bihulebetændelse, tilstoppet og løbende næse, nysen 
• chest cold, sore throat, inflammation of the sinuses, stuffy and runny nose, sneezing
Patienter, der får immunsuppressiv behandling med kombinationer af lægemidler, inklusive mycophenolatmofetil, har forøget risiko for at udvikle lymfomer og andre maligne lidelser, især i huden (se pkt. 
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).
Myfenax 250 mg kapsler, hårde 
Myfenax 250 mg hard capsules
• Informationsmateriale for patienter 
• Patient information pack
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 dagligt 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. 
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).
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. 
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 drug-drug interaction were seen.
mycophenolatmofetil oralt to gange dagligt, var typen og hyppigheden af bivirkninger generelt den samme som dem, der observeredes hos voksne patienter, som fik 1 g mycophenolatmofetil to gange dagligt. 
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/m2 mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1°g mycophenolate mofetil twice daily.
Den systemiske eksponering af denne dosis repræsenterer 2-3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 2 g dagligt til nyretransplanterede patienter og 1,3-2 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g dagligt til hjertetransplanterede patienter. 
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.
• hudkræft eller godartede vækster på huden. 
• skin cancer, non-cancerous growth of the skin
Patienter, der får immunsuppressiv behandling med kombinationer af lægemidler, som inkluderer Myfenax, har forøget risiko for at udvikle lymfomer og andre maligne lidelser, især i huden (se pkt. 
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including Myfenax, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8).
Nyretransplantation 
Kidney Transplant
Afstødning af nyretransplantat medfører ingen ændringer af MPA's farmakokinetik; dosisreduktion eller afbrydelse af Myfenax er ikke nødvendig. 
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 Myfenax is not required.
Meget almindeligAlmindelig Kramper, hypertoni, tremor, somnolens, muskelsvaghed, svimmelhed, hovedpine, paræstesier, smagsforstyrrelser 
Convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysgeusia
Den systemiske eksponering af denne dosis var ca. 0,5 gange den kliniske eksponering af den anbefalede kliniske dosis på 2 g dagligt til nyretransplanterede patienter og ca. 0,3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g dagligt til hjertetransplanterede patienter. 
The systemic exposure at this dose was approximately 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.
I nogle af disse tilfælde blev serum-IgG normaliseret, når Myfenax blev erstattet af alternative immunsuppressiva. 
In some of these cases switching mycophenolate mofetil to an alternative immunosuppressant resulted in serum IgG levels returning to normal.
Forhøjede leverenzymer, forhøjet serum-creatinin, forhøjet laktatdehydrogenase, forhøjet serumcarbamid, forhøjede basiske phosphataser, vægttab 
Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased
Oral mycophenolatmofetils gennemsnitlige biotilgængelighed, baseret på MPA AUC, er 94 % i forhold til intravenøs mycophenolatmofetil. 
The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94% relative to intravenous mycophenolate mofetil. Food had no effect on the extent of absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5°g BID to renal transplant patients.
Sådan skal du tage Myfenax 
How to take Myfenax
• højt niveau af urinsyre i blodet, podagra (urinsyregigt) 
• high level of uric acid in the blood, gout
Blod og lymfesystem Meget almindelig Leukopeni, trombocytopeni, anæmi Almindelig Pancytopeni, leukocytose 
Very common Leukopenia, thrombocytopenia, anaemia Common
Der er observeret nedsat eksponering af MPA, når antacida, såsom magnesium-og aluminiumhydroxider, og protonpumpehæmmere, inklusive lansoprazol og pantoprazol, bliver administreret sammen med mycophenolat mofetil. Der blev ikke set signifikante forskelle i hyppigheden af afstødning eller tab af transplantat hos mycophenolat mofetil-patienter, som tog protonpumpehæmmer versus mycophenolat mofetil-patienter, som ikke tog protonpumpehæmmer. 
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.
4.3), inden behandling med Myfenax påbegyndes, under behandlingen og i seks uger efter behandlingsophør, medmindre seksuel afholdenhed er den valgte form for prævention . 
Therefore women with childbearing potential must use at least one form of reliable contraception (see section 4.3) before starting Myfenax therapy, during therapy, and for six weeks after stopping the therapy, unless abstinence is the chosen method of contraception.
I nogle af disse tilfælde sås forbedringer i de respiratoriske symptomer, når for mycophenolatmofetil blev erstattet af alternative immunsuppressiva. 
In some of these cases switching mycophenolate mofetil to another immunosuppressant resulted in improvement in respiratory symptoms.
Den anbefalede daglige dosis er 8 kapsler (2 g af den aktive bestanddel) indtaget som to separate doser. 
The recommended daily dose is 8 capsules (2°g of the active ingredient) taken as 2 separate doses.
• væskeophobning i lungen, stakåndethed, hoste 
• accumulation of fluid in the lung, shortness of breath, cough
Aktivt stof: mycophenolatmofetil. 
• The active substance is mycophenolate mofetil.
Der er rapporteret om enkelte tilfælde af interstitiel lungesygdom og lungefibrose hos patienter, som fik mycophenolatmofetil i kombination med andre immunsuppressiva. 
There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated with mycophenolate mofetil in combination with other immunosuppressants, some of which have been fatal.
Anvendelse i forbindelse med nyretransplantation: 
Use in cardiac transplant:
Der foreligger ingen data for hjertetransplanterede patienter med svær leverparenkymsygdom. 
No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Mave-tarm-kanalen Meget almindelig Opkastning, abdominalsmerter, diarré, kvalme Almindelig Gastrointestinal blødning, peritonitis, ileus, colitis, mavesår, ulcus duodeni, gastritis, oesophagitis, stomatitis, obstipation, dyspepsi, flatulens, opstød Lever og galdeveje Meget almindeligAlmindelig Hepatitis, icterus, hyperbilirubinæmi Hud og subkutane væv Meget almindeligAlmindelig Hud hypertrofi, udslæt, acne, alopeci 
Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
Hvis det er tilfældet, skal en graviditetstest udføres umiddelbart før behandlingen initieres og en yderligere test udføres 8 -10 dage senere. 
It is recommended that the second test should be performed 8-10 days after the first test. For transplants from deceased donors, if it is not possible to perform two tests 8-10 days apart before treatment starts (because of the timing of transplant organ availability), a pregnancy test must be performed immediately before starting treatment and a further test performed 8-10 days later.
I kontrollerede kliniske studier hos nyre- (2 g data), hjerte- og levertransplanterede patienter, som kontrolleredes i mindst 1 år, udvikledes lymfoproliferativ sygdom eller lymfomer hos 0,6 % af de patienter som fik mycophenolatmofetil (2 eller 3 g dagligt) sammen med andre immunsuppressive stoffer. 
Lymphoproliferative disease or lymphoma developed in 0.6% of patients receiving mycophenolate mofetil (2°g or 3°g daily) in combination with other immunosuppressants in controlled clinical trials of renal (2°g data), cardiac and hepatic transplant patients followed for at least 1°year.
Den anbefalede dosis til hjertetransplantationspatienter er 1,5 g administreret to gange dagligt (døgndosis, 3 g). 
The recommended dose in cardiac transplant patients is 1.5°g administered twice daily (3°g daily dose).
Det skal du vide, før du begynder at tage Myfenax Sådan skal du tage Myfenax Bivirkninger 
What Myfenax is and what it is used for What you need to know before you take Myfenax How to take Myfenax
• infektion i fordøjelseskanalen 
• infection of the digestive tract
Ødemer, feber, kulderystelser, smerter, utilpashed, asteni 
Oedema, pyrexia, chills, pain, malaise, asthenia
Den anbefalede dosis til nyretransplantationspatienter er 1,0 g administreret to gange dagligt (døgndosis, 2 g). 
The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Den anbefalede daglige dosis er 4 tabletter (2 g af den aktive bestanddel) indtaget som to separate doser. 
The recommended daily dose is 4°tablets (2°g of the active ingredient) taken as 2°separate doses.
• svampeinfektion i fordøjelseskanalen 
• fungal infection of the digestive tract
Den anbefalede daglige dosis er 12 kapsler (3 g af den aktive bestanddel) indtaget som to separate doser. 
The recommended daily dose is 12°capsules (3°g of the active ingredient) taken as 2 separate doses.
Den anbefalede orale Myfenax-dosis til levertransplantationspatienter er 1,5 g to gange dagligt (en døgndosis på 3 g). 
The recommended oral dose in hepatic transplant patients is 1.5°g administered twice daily (3°g daily dose).
Sort jernoxid (E172) 
Yellow iron oxide (E172)