FrancophonIA/ELRC3.0 huggingface dataset:
English: Heart Transplant
Danish: Hjertetransplantation
English: • vomiting, stomach pain, diarrhoea, feeling sick
Danish: • opkastning, mavesmerter, diarré, kvalme
English: 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.
Danish: Myfenax 500 mg filmovertrukket tabletter fås i PVC/PVdC-aluminium blistre i pakningstørrelser på 50 og 150 eller 50x1 tabletter pr. karton.
English: Other medicines and Myfenax
Danish: Brug af anden medicin sammen med Myfenax
English: There have been published reports of bronchiectasis in adults and children who received mycophenolate mofetil in combination with other immunosuppressants.
Danish: Der er publicerede tilfælde af bronkiektasi hos voksne og børn, der har fået for mycophenolatmofetil i kombination med andre immunsuppressiva.
English: 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.
Danish: 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.
English: Men must not donate semen during treatment with Myfenax and for at least 90°days after stopping treatment.
Danish: Mænd må ikke være sæddonorer under behandling med Myfenax og i mindst 90 dage efter behandlingens ophør.
English: Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide
Danish: Sort blæk indeholder: Sort jernoxid (E172), propylenglycol og kaliumhydroxid
English: Myfenax should not be used during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6).
Danish: Myfenax må ikke anvendes under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet (se pkt.
English: 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.
Danish: 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.
English: • if you are breast-feeding.
Danish: - Hvis du ammer.
English: Body: caramel opaque, printed ‘250' axially in black ink.
Danish: Krop: er uigennemsigtig karamelfarvet printet ”250” aksialt med sort blæk.
English: 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).
Danish: 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).
English: Transparent PVC/PVdC - aluminium blisters in pack sizes of 100 or 300 or 100 x 1 capsules per carton.
Danish: Transparent PVC/PVdC-aluminium blister i pakningsstørrelser af 100 eller 300 eller 100x1 kapsler pr. karton.
English: Transparent PVC/PVdC-aluminium blisters in pack sizes of 50 or 150 or 50 x 1 tablets per carton.
Danish: Transparent PVC/PVdC-aluminium blister i pakningsstørrelser af 50 eller 150 eller 50x1 tabletter pr. karton.
English: Treatment should not be initiated without providing a negative pregnancy test result to rule out unintended use in pregnancy.
Danish: For at udelukke en uønsket anvendelse under graviditet må behandling ikke initieres, uden at en negativ graviditetstest foreligger.
English: Myfenax 500 mg Film-coated Tablets
Danish: Myfenax 500 mg filmovertrukne tabletter
English: 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.
Danish: Myfenax 250 mg kapsler, hårde fås i PVC/PVdC-aluminium blister i pakningsstørrelser på 100 eller 300 eller 100x1 kapsler pr. karton.
English: Myfenax 250mg hard capsules Mycophenolate mofetil
Danish: Myfenax 250 mg kapsler, hårde Mycophenolatmofetil
English: 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.
Danish: 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.
English: You must not donate blood during treatment with Myfenax and for at least 6 weeks after stopping treatment.
Danish: Du må ikke give blod under behandling med Myfenax og i mindst 6 uger efter behandlingens ophør.
English: The pharmacokinetics of oral contraceptives were unaffected by co-administration of mycophenolate mofetil (see also section 4.5).
Danish: Farmakokinetikken af orale kontraceptiva påvirkedes ikke af samtidig administration af mycophenolatmofetil (se også pkt.
English: • constipation, indigestion, wind (flatulence), belching
Danish: • forstoppelse, fordøjelsesbesvær, luft i maven (flatulens), bøvsen
English: What you need to know before you take Myfenax
Danish: Det skal du vide, før du begynder at tage Myfenax
English: 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).
Danish: 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).
English: Liver Transplant
Danish: Levertransplantation
English: This means taking 4 capsules in the morning then 4 capsules in the evening.
Danish: Det vil sige, at man skal tage 4 kapsler om morgenen og 4 kapsler om aftenen.
English: In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg/kg/day caused malformations (including anophthalmia, agnathia and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
Danish: I et studie af fertilitet og reproduktion udført på hunrotter forårsagede orale doser på 4.5 mg/kg/dag misdannelser (inkl.
English: There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving mycophenolate mofetil in combination with other immunosuppressants.
Danish: Der er rapporteret hypogammaglobulinæmi i forbindelse med tilbagevendende infektioner hos patienter, der har fået for mycophenolatmofetil i kombination med andre immunsuppressiva.
English: Hard capsules
Danish: Kapsler, hårde
English: The highest dose tested in the animal carcinogenicity studies resulted in approximately 2-3 times the systemic exposure (AUC or Cmax) observed in renal transplant patients at the recommended clinical dose of 2 g/day and 1.3-2 times the systemic exposure (AUC or Cmax) observed in cardiac transplant patients at the recommended clinical dose of 3 g/day.
Danish: Den i dyre 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.
English: Advice that patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
Danish: Vejledning om, at patienter ikke må være bloddonorer under behandlingen og i mindst 6 uger efter, at mycophenolat er seponeret.
English: • distortion of the sense of taste
Danish: • ændringer i smagssansen
English: This medicinal product contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. hårde kapsel, dvs. det er i det væsentlige natrium-frit.
English: 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.
Danish: 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.
English: Myfenax 500 mg film-coated tablets Mycophenolate mofetil
Danish: Myfenax 500 mg filmovertrukne tabletter Mycophenolatmofetil
English: Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia Psychiatric disorders Very commonCommon
Danish: 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
English: Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
Danish: Patienten må ikke donere blod under behandlingen og i mindst 6 uger efter seponering af mycophenolat.
English: Indigo carmine aluminium lake (E132) Iron oxide black (E172) Iron oxide red (E172)
Danish: Indigocarmin (E 132) Jernoxid, sort (E172) Jernoxid, rød (E172)
English: • faster heart beat
Danish: • hurtigere hjerteslag
English: 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.
Danish: 4.6 (f.eks. prævention, graviditetstests) før, under og efter behandling med mycophenolat.
English: Cap: light blue opaque printed ‘M' axially in black ink.
Danish: Hoved: er uigennemsigtig lyseblå printet ”M” aksialt med sort blæk.
English: • chest cold, sore throat, inflammation of the sinuses, stuffy and runny nose, sneezing
Danish: • bronkitis, ondt i halsen, bihulebetændelse, tilstoppet og løbende næse, nysen
English: Patients receiving immunosuppressive regimens involving combinations of medicinal products, including mycophenolate mofetil, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.4).
Danish: Patienter, der får immunsuppressiv behandling med kombinationer af lægemidler, inklusive mycophenolatmofetil, har forøget risiko for at udvikle lymfomer og andre maligne lidelser, især i huden (se pkt.
English: Myfenax 250 mg hard capsules
Danish: Myfenax 250 mg kapsler, hårde
English: • Patient information pack
Danish: • Informationsmateriale for patienter
English: The systemic exposure at these levels is approximately equivalent to or less than 0.5°times the clinical exposure at the recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3°times the clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients (see section 4.6).
Danish: Den systemiske eksponering på disse niveauer er omtrent lig med eller mindre end 0,5 gange den kliniske eksponering ved den anbefalede dosis på 2 g 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.
English: When comparing rates of transplant rejection, rates of graft loss or adverse event profiles between mycophenolate mofetil patients with and without concomitant telmisartan medication, no clinical consequences of the pharmacokinetic drug-drug interaction were seen.
Danish: Der blev ikke set kliniske konsekvenser af de farmakokinetiske lægemiddelinteraktioner ved sammenligning af hyppigheden af afstødning af transplantat eller tab af transplantat eller bivirkningsprofilen mellem mycophenolatmofetil-patienter med og uden samtidig telmisartan-medicinering.
English: The 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.
Danish: 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.
English: The systemic exposure at this dose represents 2-3°times the clinical exposure at the recommended clinical dose of 2 g/day in renal transplant patients and 1.3-2°times the clinical exposure at the recommended clinical dose of 3 g/day in cardiac transplant patients.
Danish: Den systemiske eksponering af denne dosis repræsenterer 2-3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 2 g dagligt til nyretransplanterede patienter og 1,3-2 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g dagligt til hjertetransplanterede patienter.
English: • skin cancer, non-cancerous growth of the skin
Danish: • hudkræft eller godartede vækster på huden.
English: 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).
Danish: 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.
English: Kidney Transplant
Danish: Nyretransplantation
English: Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of Myfenax is not required.
Danish: Afstødning af nyretransplantat medfører ingen ændringer af MPA's farmakokinetik; dosisreduktion eller afbrydelse af Myfenax er ikke nødvendig.
English: Convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysgeusia
Danish: Meget almindeligAlmindelig Kramper, hypertoni, tremor, somnolens, muskelsvaghed, svimmelhed, hovedpine, paræstesier, smagsforstyrrelser
English: 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.
Danish: 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.
English: In some of these cases switching mycophenolate mofetil to an alternative immunosuppressant resulted in serum IgG levels returning to normal.
Danish: I nogle af disse tilfælde blev serum-IgG normaliseret, når Myfenax blev erstattet af alternative immunsuppressiva.
English: Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased
Danish: Forhøjede leverenzymer, forhøjet serum-creatinin, forhøjet laktatdehydrogenase, forhøjet serumcarbamid, forhøjede basiske phosphataser, vægttab
English: 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.
Danish: Oral mycophenolatmofetils gennemsnitlige biotilgængelighed, baseret på MPA AUC, er 94 % i forhold til intravenøs mycophenolatmofetil.
English: How to take Myfenax
Danish: Sådan skal du tage Myfenax
English: • high level of uric acid in the blood, gout
Danish: • højt niveau af urinsyre i blodet, podagra (urinsyregigt)
English: Very common Leukopenia, thrombocytopenia, anaemia Common
Danish: Blod og lymfesystem Meget almindelig Leukopeni, trombocytopeni, anæmi Almindelig Pancytopeni, leukocytose
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 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.
English: 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.
Danish: 4.3), inden behandling med Myfenax påbegyndes, under behandlingen og i seks uger efter behandlingsophør, medmindre seksuel afholdenhed er den valgte form for prævention .
English: In some of these cases switching mycophenolate mofetil to another immunosuppressant resulted in improvement in respiratory symptoms.
Danish: I nogle af disse tilfælde sås forbedringer i de respiratoriske symptomer, når for mycophenolatmofetil blev erstattet af alternative immunsuppressiva.
English: The recommended daily dose is 8 capsules (2°g of the active ingredient) taken as 2 separate doses.
Danish: Den anbefalede daglige dosis er 8 kapsler (2 g af den aktive bestanddel) indtaget som to separate doser.
English: • accumulation of fluid in the lung, shortness of breath, cough
Danish: • væskeophobning i lungen, stakåndethed, hoste
English: • The active substance is mycophenolate mofetil.
Danish: Aktivt stof: mycophenolatmofetil.
English: 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.
Danish: Der er rapporteret om enkelte tilfælde af interstitiel lungesygdom og lungefibrose hos patienter, som fik mycophenolatmofetil i kombination med andre immunsuppressiva.
English: Use in cardiac transplant:
Danish: Anvendelse i forbindelse med nyretransplantation:
English: No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Danish: Der foreligger ingen data for hjertetransplanterede patienter med svær leverparenkymsygdom.
English: Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
Danish: 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
English: It is recommended that the second test should be performed 8-10 days after the first test. For transplants from deceased donors, if it is not possible to perform two 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.
Danish: Hvis det er tilfældet, skal en graviditetstest udføres umiddelbart før behandlingen initieres og en yderligere test udføres 8 -10 dage senere.
English: 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.
Danish: 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.
English: The recommended dose in cardiac transplant patients is 1.5°g administered twice daily (3°g daily dose).
Danish: Den anbefalede dosis til hjertetransplantationspatienter er 1,5 g administreret to gange dagligt (døgndosis, 3 g).
English: What Myfenax is and what it is used for What you need to know before you take Myfenax How to take Myfenax
Danish: Det skal du vide, før du begynder at tage Myfenax Sådan skal du tage Myfenax Bivirkninger
English: • infection of the digestive tract
Danish: • infektion i fordøjelseskanalen
English: Oedema, pyrexia, chills, pain, malaise, asthenia
Danish: Ødemer, feber, kulderystelser, smerter, utilpashed, asteni
English: The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Danish: Den anbefalede dosis til nyretransplantationspatienter er 1,0 g administreret to gange dagligt (døgndosis, 2 g).
English: The recommended daily dose is 4°tablets (2°g of the active ingredient) taken as 2°separate doses.
Danish: Den anbefalede daglige dosis er 4 tabletter (2 g af den aktive bestanddel) indtaget som to separate doser.
English: • fungal infection of the digestive tract
Danish: • svampeinfektion i fordøjelseskanalen
English: The recommended daily dose is 12°capsules (3°g of the active ingredient) taken as 2 separate doses.
Danish: Den anbefalede daglige dosis er 12 kapsler (3 g af den aktive bestanddel) indtaget som to separate doser.
English: The recommended oral dose in hepatic transplant patients is 1.5°g administered twice daily (3°g daily dose).
Danish: Den anbefalede orale Myfenax-dosis til levertransplantationspatienter er 1,5 g to gange dagligt (en døgndosis på 3 g).
English: Yellow iron oxide (E172)
Danish: Sort jernoxid (E172)
English: The recommended daily dose is 6°tablets (3°g of the active ingredient) taken as 2°separate doses.
Danish: Den anbefalede daglige dosis er 6 tabletter (3 g af den aktive bestanddel) indtaget som to separate doser.
English: • inflammation of the digestive tract
Danish: • betændelse af fordøjelseskanalen
English: By interfering with enterohepatic circulation of the drug, bile acid sequestrants such as cholestyramine, reduce MPA AUC (see section 4.9).
Danish: Galdesyrekompleksdannere såsom colestyramin, reducerer MPAs AUC ved at interferere med det enterohepatiske kredsløb af lægemidlet (se pkt.
English: System organ class Frequency Adverse drug reactions hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia Psychiatric disorders Very commonCommon
Danish: Hudkræft, benignt neoplasme af huden Blod og lymfesystem Meget almindelig Leukopeni, trombocytopeni, anæmi Almindelig Pancytopeni, leukocytose
English: • cold sores, shingles
Danish: • forkølelsessår, helvedesild
English: • infection of the urinary tract
Danish: • urinvejsinfektion
English: EU/1/12/810/001 Krystexxa 8 mg/ml
Danish: EU/1/12/810/001 Krystexxa 8 mg/ml Koncentrat til infusionsvæske, opløsning
English: 1 vial
Danish: 1 ml
English: Pack size
Danish: Pakningsstør relse