natgillin/translations-raw huggingface dataset:
Efter markedsføring er der blevet observeret medfødte misdannelser hos børn af patienter, der har været eksponeret for mycophenolatmofetil i kombination med andre immunsuppressiva, se pkt 4.6.
Congenital malformations have been observed post-marketing in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants, see section 4.6.
• spredning af lymfevæv, herunder kræftsvulster.
• proliferation of the lymphatic tissue, including malignant tumours
Hvis du holder op med at tage Myfenax
If you stop taking Myfenax
4.8) end hos voksne, kan det blive nødvendigt forbigående at nedsætte dosis eller afbryde behandlingen under behørig hensyntagen til relevante kliniske faktorer, inklusive bivirkningssværhedsgraden.
As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
Ciclosporin's CsA farmakokinetik påvirkes ikke af mycophenolatmofetil.
Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
Hos patienter med nedsat nyrefunktion, som får Myfenax og ganciclovir, eller deres prodrugs, f.eks. valganciclovir, samtidig bør dosisanbefalingerne for ganciclovir følges og patienterne monitoreres omhyggeligt.
In patients with renal impairment in whom mycophenolate mofetil and ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered the dose recommendations for ganciclovir should be observed and patients monitored carefully.
Disse infektioner er ofte forbundet med en høj samlet immunsuppressiv belastning og kan forårsage alvorlige eller dødelige tilstande.
These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Den anbefalede dosering på 1 g administreret to gange dagligt til nyretransplantationspatienter og 1,5 g administreret to gange dagligt til hjerte- eller levertransplanterede patienter er passende til ældre.
The recommended dose of 1°g administered twice a day for renal transplant patients and 1.5°g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly.
Hos nyretransplanterede patienter med svær, kronisk nedsat nyrefunktion (glomerulær filtration < 25 ml/min/1,73 m2), bortset fra perioden den umiddelbart efter transplantionen, bør doser på mere end 1 g administreret to gange dagligt undgås.
In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73°m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
Hoved
Cap
Myfenax må ikke anvendes hos kvinder i den fertile alder, som ikke anvender meget sikker kontraception (se pkt.
Myfenax should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
Indlægsseddel: Information til brugeren Myfenax 500 filmovertrukne tabletter
Package leaflet: Information for the user Myfenax 500mg film-coated tablets
• anfald, øget muskelspænding, rysten, søvnighed, svimmelhed, hovedpine, snurren, prikken eller følelsesløshed
• fit, increased tension of the muscles, shaking, sleepiness, feeling dizzy, headache, tingling, pricking or numbness
• abnormiteter i ørerne (f.eks. abnormt formet eller manglende ydre øre), tillukning af øregangen
• Abnormalities of the ear (e.g. abnormally formed or absent external ear), external auditory canal atresia (middle ear);
Dosisjusteringer er ikke nødvendigt hos nyretransplanterede patienter med svær leverparenkymlidelse.
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Det vil sige, at man skal tage 3 tabletter om morgenen og 3 tabletter om aftenen.
This means taking 3°tablets in the morning then 3°tablets in the evening.
Hver kapsel indeholder 250 mg mycophenolatmofetil.
Each capsule contains 250 mg mycophenolate mofetil.
Det vil sige, at man skal tage 6 kapsler om morgenen og 6 kapsler om aftenen.
This means taking 6°capsules in the morning then 6°capsules in the evening.
Der foreligger ingen data for hjerte- eller levertransplanterede patienter med svær, kronisk nedsat nyrefunktion.
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
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.