natgillin/translations-raw huggingface dataset:
Patienter, som får Myfenax, skal have besked om straks at indberette alle tegn på infektion, uventede blodudtrækninger, blødning eller andre manifestationer af knoglemarvsdepression.
Patients receiving Myfenax should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
4. 8).
3 Patients treated with immunosuppressants, including Myfenax, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Hvis der optræder neutropeni (det absolutte neutrofillocyttal < 1. 3 103/ μl), skal behandlingen med Myfenax måske afbrydes eller stoppes.
If neutropenia develops (absolute neutrophil count < 1.3 x 103/μ l) it may be appropriate to interrupt or discontinue Myfenax.
4. 5).
Patients should be advised that during treatment with Myfenax, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Eftersom mycophenolatmofetil er blevet sat i forbindelse med en øget incidens af bivirkninger i fordøjelsessystemet inklusive sjældne tilfælde af ulceration, blødning og perforation bør Myfenax administreres med forsigtighed til patienter med aktiv alvorlig sygdom i fordøjelsessystemet.
Because mycophenolate has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation, Myfenax should be administered with caution in patients with active serious digestive system disease.
Myfenax er en inosinmonofosfatdehydrogenase (IMPDH) hæmmer.
Myfenax is an inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Af teoretiske grunde bør det derfor undgås til patienter med sjældne arvelig mangel på hypoxantin- guanin- fosforibosyltransferase (HGPRT) såsom Lesch- Nyhan og Kelley- Seegmiller syndrom.
On theoretical grounds, therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Myfenax bør ikke administreres samtidig med azathioprin, da en sådan samtidig administration ikke er blevet undersøgt.
It is recommended that Myfenax should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
I betragtning af cholestyramins signifikante reduktion af MPA- AUC (areal under kurven) skal man på grund af risikoen for at reducere virkningen af Myfenax være forsigtig med samtidig administration af Myfenax og lægemidler, som interfererer med det enterohepatiske kredsløb.
In view of the significant reduction in the AUC (area under the curve) of MPA by cholestyramine, caution should be used in the concomitant administration of Myfenax with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of Myfenax.
5. 2).
Cholestyramine: following single dose administration 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).
Der skal iagttages forsigtighed ved samtidig administration pga. muligheden for nedsat effekt af mycophenolatmofetil.
Caution should be used during concomitant administration because of the potential to reduce efficacy of Myfenax.
Der skal iagttages forsigtighed med lægemidler, som interfererer med den enterohepatiske cirkulation pga. risikoen for nedsat effekt af mycophenolatmofetil.
4 Medicinal products that interfere with enterohepatic circulation: caution should be used with medicinal products that interfere with enterohepatic circulation because of their potential to reduce the efficacy of Myfenax.
Baseret på resultaterne fra en undersøgelse med enkelt dosis indgift af anbefalede doser af oral mycophenolatmofetil og intravenøs ganciclovir og de kendte virkninger af nedsat nyrefunktion på mycophenolatmofetils og ganciclovirs farmakokinetik (se pkt. 4. 2), forudses det at samtidig administration af disse lægemidler (som konkurrerer om den renale tubulære ekskretionsmekanisme) vil medføre forhøjelser af MPAG og ganciclovir koncentrationerne.
Ganciclovir; based on the results of a single dose administration study of recommended doses of oral mycophenolate and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate (see section 4.2) and ganciclovir, it is anticipated that co- administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Der forudses ingen væsentlig ændring af MPA’ s farmakokinetik og dosisjustering af mycophenolatmofetil er ikke nødvendig.
No substantial alteration of MPA pharmacokinetics is anticipated and mycophenolate mofetil dose adjustment is not required.
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 which Myfenax and ganciclovir or its prodrugs, e. g. valganciclovir, are co-administered the dose recommendations for ganciclovir should be observed and patients monitored carefully.
Hos patienter, som ikke fik ciclosporin, sås ved samtidig administration af mycophenolatmofetil og rifampicin et fald på 18- 70% i MPA- eksponeringen (AUC 0- 12 timer).
Rifampicin: 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%.
For at opretholde den kliniske effekt bør MPA- eksponeringen overvåges, og Myfenax- doserne justeres i forhold til dette, når rifampicin administreres samtidigt.
It is recommended to monitor MPA exposure levels and to adjust Myfenax doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
4. 4).
Sirolimus: in renal transplant patients, concomitant administration of mycphenolate mofetil and CsA resulted in reduced MPA exposures by 30-50% compared with patients receiving the combination of sirolimus and similar doses of Myfenax (see also section 4.4).
Når mycophenolatmofetil blev administreret samtidig med sevelamer, faldt MPA - Cmax og AUC 0- 12 timer med henholdsvis 30% og 25%, dog uden at dette havde kliniske konsekvenser (f. eks. i form af transplantatafstødning).
Sevelamer: decrease in MPA Cmax and AUC by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i. e. graft rejection).
Myfenax bør imidlertid administreres mindst én time før eller tre timer efter indtagelsen af sevelamer for at minimere dets indvirkning på MPA- absorptionen.
It is recommended, however, to administer Myfenax at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Hos levertransplanterede patienter, der indledningsvis blev behandlet med mycophenolatmofetil og tacrolimus samtidigt, blev MPAs Cmax og AUC – mycophenolatmofetils aktive metabolit - ikke signifikant påvirket af den samtidige administration af tacrolimus.
Tacrolimus: in liver transplant recipients initiated on mycophenolate mofetil and tacrolimus, the AUC and Cmax of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by trough tacrolimus level.
Hos levertransplanterede patienter, blev AUC for tacrolimus dog øget med ca.
In renal transplant patients, the tacrolimus concentration did not appear to be altered by mycophenolate mofetil.
4. 4).
However, in hepatic transplant patients, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5 g taken twice [BID] a day, morning and evening]) were administered to patients taking tacrolimus (see also section 4.4).
5 sekretion, konkurrere med MPAG og derved forhøje plasmakoncentrationerne af MPAG eller andre stoffer, der udskilles ved tubulær sekretion.
Thus, other substances known to undergo renal tubular secretion may compete with MPAG and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular secretion.
4. 4).
5 Live vaccines: live vaccines should not be given to patients with an impaired immune response The antibody response to other vaccines may be diminished (see also section 4.4).
Det anbefales, at behandling med Myfenax ikke initieres før en negativ graviditetstest foreligger.
It is recommended that Myfenax therapy should not be initiated until a negative pregnancy test has been obtained.
Effektiv antikonception skal anvendes før behandling med mycophenolatmofetil påbegyndes, under behandlingen og i seks uger efter behandlingsophør (se pkt.
Effective contraception must be used before beginning Myfenax therapy, during therapy, and for six weeks following discontinuation of therapy (see section 4.5).
Anvendelse af Myfenax anbefales ikke under graviditet og bør begrænses til tilfælde, hvor der ikke findes andre, mere passende behandlinger.
The use of Myfenax is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available.
Myfenax bør kun anvendes til gravide kvinder, hvis den potentielle fordel er større end den potentielle risiko for fostret.
Myfenax should be used in pregnant women only if the potential benefit outweighs the potential risk to the foetus.
4. 3).
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).
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 daglig) sammen med andre immunsupprimerende stoffer, mukokutane candidainfektioner, cytomegalovirus (CMV)
The most common opportunistic infections in patients receiving mycophenolate (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials of 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.
Børn og unge:
6 Children and adolescents:
Ældre patienter (≥ 65 år) har i almindelighed større risiko for uønskede hændelser pga. immunsuppresion.
Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to immunosuppression.
Ældre patientersom får Myfenax som led i et kombinations immunsuppressivt regi, kan have større risiko for 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.
Uønskede hændelser, som var ” sandsynligt relateret ” eller ” muligt relateret ” til mycophenolatmofetil, og som rapporteredes hos de patienter, der blev behandlet med mycophenolatmofetil i de kontrollerede studier med nyre - (2 g data), hjerte - og levertransplanterede patienter er anført i den følgende tabel. ´
Adverse reactions, probably or possibly related to mycophenolate, reported in ≥ 1/ 10 and in ≥ 1/ 100 to < 1/ 10 of patients treated with mycophenolate in the controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients are listed in the following table.
Inden for hver frekvensgruppering er bivirkningerne opstillet efter faldende alvorlighed.
Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (≤ 1/ 10,000), not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
Gastrointestinal blødning, peritonitis, ileus, colitis,
Vomiting, abdominal pain, diarrhoea, nausea Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
almindelig
Renal and urinary disorders
Meget almindelig
- Renal impairment
Almindelig
Adverse drug reactions
Arthralgi
Skin and
ernæring
subcutaneous
Acidose, hyperkaliæmi, hypokaliæmi, hyperglykæmi, hypomagnesæmi, hypocalcæmi, hyperkolesterolæmi,
Skin hypertrophy, rash, acne, alopecia
hyperlipæmi, hypophosphatæmi, hyperuricæmi, ægte gigt, anoreksi Infektioner og
tissue disorders Musculoskeletal and connective tissue disorders
almindelig
- Arthralgia
Herpes simplex, herpes zoster
Metabolism and nutrition disorders
Pneumoni, influenza, infektion i luftrøret, respiratorisk moniliasis, gastrointestinal infektion, candidiasis,
- Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
gastroenteritis, infektion, bronkitis, pharyngitis, sinuitis, svampeinfektion i huden, hud candidiasis, vaginal candidiasis, rhinitis Benigne, maligne
Infections and infestations
Hypotension, hypertension, vasodilatation
- Hypotension, hypertension, vasodilatation - Oedema, pyrexia, chills, pain, malaise, asthenia
Hepatitis, icterus, hyperbilirubinæmi
Hepatobiliary disorders Psychiatric disorders
Agitation, konfusion, depression, angst, abnorm tankevirksomhed, insomnia
- Hepatitis, jaundice, hyperbilirubinaemia - Agitation, confusional state, depression, anxiety, thinking abnormal, insomnia
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 immunosuppressiva herunder Myfenax.
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.
Agranulocytose (ikke almindelig) og neutropeni er rapporteret; derfor tilrådes regelmæssig monitorering af patienter i behandling med Myfenax (se pkt.
Agranulocytosis (uncommon) and neutropenia have been reported; therefore regular monitoring of
4. 9 Overdosering
9 patients taking Myfenax is advised (see section 4.4).
Der er modtaget rapporter om overdosering med mycophenolatmofetil fra kliniske undersøgelser og efter markedsføring.
Hypersensitivity: hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
I adskillige af disse tilfælde blev der ikke rapporteret uønskede hændelser.
Congenital disorders: see further details in section 4.6.
4. 4).
If neutropenia develops, dosing with Myfenax should be interrupted or the dose reduced (see section 4.4).
9 5. 1 Farmakodynamiske egenskaber
5.1 Pharmacodynamic properties
MPA C max var dog nedsat med 40% i nærvær af føde.
However, MPA Cmax was decreased by 40% in the presence of food.
Ved høje MPAG - koncentrationer (> 100 µg/ ml) fjernes dog mindre mængder MPAG.
However, at high MPAG plasma concentrations (> 100μ g/ ml), small amounts of MPAG are removed.
40% lavere sammenlignet med den sene posttransplantationsperiode (3 – 6 måneder efter transplantationen).
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).
I en enkelt- dosis undersøgelse (6 personer per gruppe) blev middel plasma MPA AUC hos personer med svær, kronisk nyreinsufficiens (glomerulær filtrationsrate < 25 ml min- 1 1, 73 m- 2) observeret til 28- 75% højere i forhold til middelværdierne hos normale, sunde personer eller personer med mindre grad af nyreinsufficiens.
In a single dose study (6 subjects/ group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 ml min-1 1.73 m-2) were 28-75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Imidlertid var middel enkelt- dosis MPAG AUC 3- 6 gange højere hos personer med svær nyreinsufficiens end hos personer med let nyreinsufficiens eller normale, sunde personer svarende til den kendte renale udskillelse af MPAG.
However, the mean single dose MPAG AUC was 3-6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
10 Hos patienter med forsinket renal transplantatfunktion post- transplantativt var middel MPA AUC 0- 12 timer sammenlignelig med, hvad man så hos post- transplantations- patienter uden forsinket transplantatfunktion.
In patients with delayed renal graft function post-transplant, mean MPA AUC (0-12h) was comparable to that seen in post-transplant patients without delayed graft function.
Justering af Myfenax- dosis er ikke nødvendig.
Dose adjustment of Myfenax does not appear to be necessary.
2 - 3 gange den systemiske eksponering (AUC eller Cmax) der er observeret hos nyre transplantationspatienter der fik den anbefalede kliniske dosis på 2 g daglig og 1, 3 - 2 gange den systemiske eksponering (AUC eller Cmax) observeret hos hjerte transplantationspatienter der fik den anbefalede kliniske dosis på 3 g daglig.
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 as 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.
Mycophenolatmofetil havde ingen effekt på fertiliteten hos hanrotter i orale doser op til 20 mg kg - 1 - dag- 1.
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg kg-1 day-1.
Den systemiske eksponering af denne dosis repræsenterer 2 - 3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 2 g daglig til nyre transplanterede patienter og 1, 3 - 2 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g daglig til hjerte transplanterede 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.
0, 3 gange den kliniske eksponering ved den anbefalede kliniske dosis
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.
Ved teratologiske undersøgelser på rotter og kaniner forekom der føtal resorption og misdannelser hos rotter ved 6 mg kg- 1 dag- 1 (inkl. anophthalmi, agnathi og hydrocephalus) og hos kaniner ved 90 mg kg - 1 dag- 1 (inkl. kardiovaskulære og nyre anomalier, såsom cordis ectopia og ectopiske nyrer og diafragma og umbilical brok) med fravær af maternel toksicitet.
In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg kg-1 day-1 (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg kg-1 day-1 (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
Disse effekter forekom ved systemiske eksponeringsniveauer som er lig med eller mindre end de kliniske niveauer ved den anbefalede dosis på 2 g daglig til nyretransplanterede patienter.
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey.
Pregelatineret majsstivelse Povidon K- 30 Croscarmellosenatrium Magnesiumstearat
Pregelatinised starch (maize) Povidone K-30 Croscarmellose sodium Magnesium stearate 12 Capsule shell:
Shellac, sort jernoxid (E172), propylenglycol og kaliumhydroxid.
Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide.
12 Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
This medicinal product does not require any special storage conditions
Da mycophenolatmofetil har demonstreret fosterbeskadigende virkning på rotter og kaniner, må Myfenax kapsler ikke åbnes eller knuses.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbit, Myfenax capsules should not be opened or crushed.
Undgå inhalation og direkte kontakt med hud og slimhinder med pulveret i Myfenax kapslerne.
Inhalation or direct contact with skin or mucous membranes of the powder contained in the capsules should be avoided.
EU/ 1/ 07/ 438/ 001 (100 kapsler) EU/ 1/ 07/ 438/ 002 (300 kapsler)
EU/ 1/ 07/ 438/ 001 (100 capsules) EU/ 1/ 07/ 438/ 002 (300 capsules)
21, februar, 2008
21 February 2008 13 10.
Myfenax 500 mg fimovertrukne tabletter
Myfenax 500 mg film-coated tablets
Myfenax tabletter må kun ordineres til patienter med en legemsoverflade på mindst 1, 5 m2, i en dosis på 1 g to gange daglig (daglig dosis:
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).
De er ikke tilstrækkelige til af komme med dosisrekommendationer, og det anbefales derfor ikke at anvende Myfenax til denne aldersgruppe.
These are insufficient to make dose recommendations and therefore use in this age group is not recommended.
Voksne: mycophenolatmofetil skal gives intravenøst i de 4 første dage efter en levertransplantation og herefter skal oral administration påbegyndes så snart det tåles.
15 Adults: intravenous mycophenolate should be administered for the first 4 days following hepatic transplant, with oral Myfenax initiated as soon after this as it can be tolerated.
Nyretransplantatafstødning medfører ingen ændringer af MPA’ s farmakokinetik; dosisreduktion eller afbrydelse af Myfenax er ikke nødvendig.
Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dose reduction or interruption of Myfenax is not required.
4. 8).
Patients treated with immunosuppressants, including Myfenax, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Lægen bør tage dette i betragtning i differentialdiagnosen hos immunosupprimerede patienter med svækket nyrefunktion eller neurologiske symptomer.
These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider 16 in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
I betragtning af colestyramins signifikante reduktion af MPA- AUC (areal under kurven) skal man på grund af risikoen for at reducere virkningen af Myfenax være forsigtig med samtidig administration af Myfenax og lægemidler, som interfererer med det enterohepatiske kredsløb.
In view of the significant reduction in the area under the curve (AUC) of MPA by cholestyramine, caution should be used in the concomitant administration of Myfenax with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of Myfenax.