natgillin/translations-raw huggingface dataset:
Der er ingen tilgængelige data for hjerte - eller levertransplantaterede patienter med svær kronisk nyreinsufficiens.
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
10 Forsinket renal transplantatfunktion:
Delayed renal graft function:
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.
Middel plasma MPAG AUC 0- 12 timer var 2- 3 gange højere end hos posttransplantationspatienter uden forsinket transplantatfunktion.
Mean plasma MPAG AUC (0- 12h) was 2-3-fold higher than in post-transplant patients without delayed graft function.
Justering af Mycophenolate mofetil Teva- dosis er ikke nødvendig.
Dose adjustment of Mycophenolate mofetil Teva does not appear to be necessary.
Med denne dosis opnåedes MPA AUC værdier svarende til hos voksne, nyretransplanterede patienter, som fik mycophenolatmofetil 1 g to gange daglig i den tidlige og sene posttransplantationsperiode.
This dose achieved MPA AUC values similar to those seen in adult renal transplant patients receiving mycophenolate at a dose of 1 g BID in the early and late post-transplant period.
MPA AUC værdier mellem aldersgrupper var sammenlignelige i den tidlige og sene posttransplantationsperiode.
MPA AUC values across age groups were similar in the early and late post- transplant period.
Farmakokinetikken hos ældre er ikke systematisk undersøgt.
Pharmacokinetic behaviour of mycophenolate in the elderly has not been formally evaluated.
Et studie om samtidig administration af mycophenolatmofetil (1 g 2 gange daglig) og orale kontraceptiva af kombinationstypen indeholdende ethinylestradiol (0, 02 - 0, 04 mg) og levonorgestrel (0, 05- 0, 15 mg), desogestrel (0, 15 mg) eller gestoden (0, 05 – 0, 10 mg) hos 18 ikke- transplanterede kvinder (som ikke fik andre immunosupresiva) i 3 konsekutive menstruationscykler viste ingen klinisk relevant påvirkning af mycophenolatmofetil på den ovulationshæmmende virkning af de orale kontraceptiva.
The pharmacokinetics of oral contraceptives were unaffected by co-administration of mycophenolate (see also section 4.5). A study of the co-administration of mycophenolate (1 g BID) and combined oral contraceptives containing ethinylestradiol (0.02 mg to 0.04 mg) and levonorgestrel (0.05 mg to 0.15 mg), desogestrel (0.15 mg) or gestodene (0.05 mg to 0.10 mg) conducted in 18 non-transplant women (not taking other immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of mycophenolate on the ovulation suppressing action of the oral contraceptives.
Den i dyre carcinogenicitetsundersøgelser højest testede dosis resulterede i ca.
5.3 Preclinical safety data 11 In experimental models, mycophenolate mofetil was not tumourigenic.
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 C max) observed in renal transplant patients as the recommended clinical dose of 2 g/ day and 1.3-2 times the systemic exposure (AUC or C max) observed in cardiac transplant patients at the recommended clinical dose of 3 g/ day.
Det kan skyldes den farmakodynamiske effekt, dvs. hæmning af nukleotidsyntesen i sensitive celler.
These effects can be related to the pharmacodynamics mode of action, i. e. inhibition of nucleotide synthesis in sensitive cells.
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.
Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg kg-1 day-1. 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.
I en undersøgelse af fertilitet og reproduktion udført på hunrotter forårsagede orale doser på 4. 5 mg kg- 1 dag- 1 misdannelser (inkl. anophthalmi, agnathi og hydrocephalus) hos det første generationsafkom ved fravær af maternel toksicitet.
In a female fertility and reproduction study conducted in rats, oral doses of 4.5 mg kg-1 day-1 caused malformations (including anophthalmia, agnathia and hydrocephaly) in the first generation offspring in the absence of maternal toxicity.
0, 5 gange den kliniske eksponering af den anbefalede kliniske dosis på 2 g daglig til nyre
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.
0, 3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g til hjertetransplanterede patienter.
The systemic exposure at these levels are 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.
4. 6
Refer to section 4.6.
Gastrointestinale virkninger observeredes hos hunden ved systemiske niveauer lig med eller mindre end det kliniske niveau ved den anbefalede dosis.
These effects occurred at systemic exposure levels that are equivalent to or less than the clinical exposure at the recommended dose of 2 g/ day for renal transplant recipients.
Dehydreringslignende gastrointestinale - og nyrepåvirkninger observeredes også hos abe ved de højeste doser (systemiske niveauer lig med eller større end kliniske niveauer).
Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended doses.
4. 8).
Gastrointestinal and renal effects consistent with dehydration were also observed in the monkey at the highest dose (systemic exposure levels equivalent to or greater than clinical exposure). The nonclinical toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in human clinical trials which now provide safety data of more relevance to the patient population (see section 4.8).
Pregelatineret majsstivelse Povidon K- 30 Croscarmellosenatrium Magnesiumstearat
Pregelatinised starch (maize) Povidone K-30 Croscarmellose sodium Magnesium stearate
Kapselskal:
12 Capsule shell:
Hoved:
Cap:
Indigo carmin (E132) Titandioxid (E171) Gelatine Krop:
Indigo carmine (E132) Titanium dioxide (E171) Gelatin Body:
Shellac, sort jernoxid (E172), propylenglycol og kaliumhydroxid.
Red iron oxide (E172) Yellow iron oxide (E! 72) Titanium dioxide (E171) Gelatin Black ink containing: shellac, black iron oxide (E172), propylene glycol and potassium hydroxide.
Transparent PVC/ PVdC- aluminium blister i pakningsstørrelser af 100 eller 300 kapsler pr. karton.
Transparent PVC/ PVdC – aluminium blisters in pack sizes of 100 or 300 capsules per carton.
Da mycophenolatmofetil har demonstreret fosterbeskadigende virkning på rotter og kaniner, må Mycophenolate mofetil Teva kapsler ikke åbnes eller knuses.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbit, Mycophenolate mofetil Teva capsules should not be opened or crushed.
Undgå inhalation og direkte kontakt med hud og slimhinder med pulveret i Mycophenolate mofetil Teva kapslerne.
Inhalation or direct contact with skin or mucous membranes of the powder contained in the capsules should be avoided.
Vask omhyggeligt med sæbe og vand, hvis en sådan kontakt forekommer; skyl øjnene med rent vand.
If such contact occurs, soap and water should be used to wash thoroughly and the eyes should be rinsed with plain water.
EU/ 1/ 07/ 439/ 001 (100 kapsler) EU/ 1/ 07/ 439/ 002 (300 kapsler)
EU/ 1/ 07/ 439/ 001 (100 capsules) EU/ 1/ 07/ 439/ 002 (300 capsules)
Dato for første tilladelse:
13 Date of first authorisation:
21, februar, 2008
21 February 2008
Mycophenolate mofetil Teva 500 mg fimovertrukne tabletter
Mycophenolate mofetil Teva 500 mg film-coated tablets
Hver tablet indeholder 500 mg mycophenolatmofetil.
Each tablet contains 500 mg mycophenolate mofetil For a full list of excipients, see section 6.1
13 3.
3.
Filmovertrukne tabletter Lys lilla oval formet filmovertrukken tablet præget med ” M500 ” på den ene side og glat på den anden side.
Film-coated tablet (tablet) Pale purple, oval shaped film-coated tablet, debossed with "M500" on one side and plain on the other side.
Den anbefalede dosis af mycophenolatmofetil er 600 mg/ m2 oralt to gange daglig (højst 2 g daglig).
Children and adolescents: the recommended dose of mycophenolate mofetil is 600 mg/ m2 administered orally twice daily (up to a maximum of 2 g daily).
Mycophenolate mofetil Teva 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:
Mycophenolate mofetil Teva 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).
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 48) 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.
Oralt Mycophenolate mofetil Teva bør gives indenfor 5 døgn efter transplantation.
Adults: oral Mycophenolate mofetil Teva should be initiated within 5 days following transplantation.
Der er ingen data vedrørende hjertetransplantationer hos børn, bør ikke anvendes til denne gruppe af patienter, før end yderligere data er tilgængelig til at understøtte dette.
15 Children and adolescents: no data are available for paediatric cardiac transplant patients, therefore use in this patients group is not recommended until further data to support this is available.
Der er ingen data vedrørende levertransplantationer hos børn, derfor anbefales det ikke til anvendelse hos denne patientgruppe før end yderligere data, til at understøtte dette, er tilgængelig.
Children and adolescents: no data are available for paediatric hepatic transplant patients, therefore use in this patient group is not recommended until further data to support this is available.
14 Den anbefalede dosering på 1, 0 g administreret to gange daglig til nyretransplantationspatienter og 1, 5 g administreret to gange daglig til hjerte - eller levertransplanterede patienter er passende til ældre.
The recommended dose of 1.0 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.
Overfølsomhed over for det aktive stof, over for mycophenolatsyre eller over for et eller flere af hjælpestofferne.
Hypersensitivity reactions to the active substance, to mycophenolic acid or any of the excipients
4. 8).
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including Mycophenolate mofetil Teva, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8).
For at minimere risikoen for hudkræft må det generelt tilrådes, at udsættelse for sollys og ultraviolet (UV) lys begrænses ved, at der bæres beskyttende beklædning, og ved at der anvendes en solblokker med en høj beskyttelsesfaktor.
As general advice to minimise the risk for skin cancer, exposure to sunlight and ultra-violet (UV) light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Patienter, som får Mycophenolate mofetil Teva, skal have besked om straks at indberette alle tegn på infektion, uventede blodudtrækninger, blødning eller andre manifestationer af knoglemarvsdepression.
16 Patients receiving Mycophenolate mofetil Teva should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Patienter på Mycophenolate mofetil Teva bør have foretaget fuldstændig blodtælling hver uge den første måned, to gange om måneden den anden og tredie behandlingsmåned og derefter
Patients taking Mycophenolate mofetil Teva should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment then monthly through the first year.
I betragtning af colestyramins signifikante reduktion af MPA- AUC (areal under kurven) skal man på grund af risikoen for at reducere virkningen af Mycophenolate mofetil Teva være forsigtig med samtidig administration af Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of Mycophenolate mofetil Teva.
Da MPAG- plasmakoncentrationer forhøjes ved tilstedeværelse af nyreinsufficiens, lige som aciclovir- koncentrationerne bliver det, er der en mulighed for, at mycophenolatmofetil og aciclovir, eller deres prodrugs, f. eks. valaciclovir, vil konkurrere om den tubulære sekretion, og at der kan ske yderligere forhøjelser af koncentrationerne af begge stoffer.
Because MPAG plasma concentrations are increased in the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs, e. g. valaciclovir, to compete for tubular secretion and further increases in concentrations of both substances may occur.
Absorptionen af mycophenolatmofetil blev nedsat, når det administreredes sammen med antacida.
17 Antacids with magnesium and aluminium hydroxides: absorption of mycophenolate mofetil was decreased when administered with antacids.
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 Mycophenolate mofetil Teva.
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 Teva dose adjustment is not required.
Hos patienter med nedsat nyrefunktion, som får Mycophenolate mofetil Teva 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 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.
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 (AUC 0-12h) of 18% to 70%.
For at opretholde den kliniske effekt bør MPA- eksponeringen overvåges, og Mycophenolate mofetil Teva - doserne justeres i forhold til dette, når rifampicin administreres samtidigt.
It is recommended to monitor MPA exposure levels and to adjust Mycophenolate mofetil Teva doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
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 C max and AUC 0-12 by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i. e. graft rejection).
Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva 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 C max of MPA, the active metabolite of mycophenolate mofetil, were not significantly affected by trough tacrolimus level.
Hos nyretransplanterede patienter blev tacrolimuskoncentrationen imidlertid tilsyneladende ikke påvirket af mycophenolatmofetil.
In renal transplant patients, the tacrolimus concentration did not appear to be
Hos levertransplanterede patienter, blev AUC for tacrolimus dog øget med ca.
18 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 a day, morning and evening [BID]) were administered to patients taking tacrolimus (see also section 4.4).
Samtidig administration af probenecid og mycophenolatmofetil forhøjer MPAG' s plasma AUC 3 gange hos aber.
Other interactions: co administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of MPAG by 3-fold.
17 Det anbefales, at behandling med Mycophenolate mofetil Teva ikke initieres før en negativ graviditetstest foreligger.
It is recommended that Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva therapy, during therapy, and for six weeks following discontinuation of therapy (see section 4.5).
4. 4).
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including mycophenolate, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.4).
I kontrollerede undersøgelser 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 daglig) sammen med andre immunsuppressive stoffer.
Lymphoproliferative disease or lymphoma developed in 0.6% of patients receiving mycophenolate (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.
Nonmelanom hudcancer indtraf hos 3, 6% af patienterne og andre maligniteter hos 1, 1%.
Non-melanoma skin carcinomas occurred in 3.6% of patients; other types of malignancy occurred in 1.1% of patients.
Sammenlignet med data efter 1 år viste sikkerhedsdata for 3 år ingen uventede ændringer mht. hyppighed af malignitet hos nyre - og hjertetransplanterede patienter.
Three-year safety data in renal and cardiac transplant patients did not 19 reveal any unexpected changes in incidence of malignancy compared to the 1-year data.
I et klinisk studie, som rekrutterede 92 børn i alderen 2- 18 år, og som fik 600 mg/ m2 mycophenolatmofetil oralt to gange daglig, var arten og hyppigheden af uønskede hændelser generelt den samme som dem, der observeredes hos voksne patienter, som fik 1 g mycophenolatmofetil to
The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18 years who where given 600 mg/ m2 mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g mycophenolate twice daily.
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.
Uønskede hændelser, som var ” sandsynligt relateret ” eller ” muligt relateret ” til mycophenolatmofetil, ogsom rapporteredes hos patienter, som blev behandlet med mycophenolatmofetil i kombination med ciclosporin og kortikosteroider i de kliniske nyre -, hjerte - og leverstudier
20 Adverse reactions, probably or possibly related to mycophenolate, reported in patients treated with mycophenolate in renal, cardiac and hepatic clinical trials when used in combination with ciclosporin and corticosteroids
Systemorgan - klasse
System organ class
Undersøgelser
Adverse drug reactions
Leukopeni, trombocytopeni, anæmi
Blood and lymphatic system disorders
Pancytopeni, leukocytose
Leukopenia, thrombocytopenia, anaemia Pancytopenia, leukocytosis
- Pleural effusion, dyspnø, hoste
- Pleural effusion, dyspnoea, cough