natgillin/translations-raw huggingface dataset:
CellCept anvendes til at forhindre kroppen i at afstøde et transplanteret organ, f. eks. en nyre, hjertet eller leveren.
CellCept is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Den måde, som CellCept skal gives på, og dosis afhænger af den type organ, som transplanteres, og af patientens alder og fysiske størrelse.
The way that CellCept should be given and the dose depend on the type of organ transplant and the patient ’ s age and size.
Ved transplantation af nyrer er den anbefalede dosis for voksne 1, 0 g to gange dagligt gennem munden (kapsler, tabletter eller oral suspension), og behandlingen skal starte inden for 72 timer efter transplantationen.
For kidney transplants, the recommended dose in adults is 1.0 g twice a day by mouth (capsules, tablets or oral suspension) starting within 72 hours after the transplant.
Det kan også gives som en infusion over to timer med start 24 timer efter transplantationen i op til 14 dage.
It can also be given as an infusion lasting two hours starting within 24 hours after the transplant, for up to 14 days.
Dosis ved behandling af børn mellem 2 og 18 år beregnes på grundlag af højde og vægt og bør gives gennem munden.
In children aged between two and 18 years, the dose of CellCept is calculated depending on height and weight and should be given by mouth.
Ved transplantation af hjerter er den anbefalede dosis til voksne 1, 5 g to gange dagligt gennem munden med start fem dage efter transplantationen.
For heart transplants, the recommended adult dose is 1.5 g twice a day by mouth, starting within five days following the transplant.
Ved transplantation af lever hos voksne bør CellCept gives som en 1 g- infusion to gange dagligt i de første fire dage efter transplantationen, hvorefter patienten skiftes over til 1, 5 g to gange dagligt gennem munden, så snart patienten kan tåle det.
For liver transplants in adults, CellCept should be given as a 1-g infusion twice a day for the first four days after the transplant, before the patient is switched to 1.5 g twice a day by mouth as soon as it can be tolerated.
CellCept er ikke anbefalet til behandling af børn, der har fået foretaget en hjerte - eller levertransplantation, da der ikke foreligger oplysninger om dets virkning på denne patientgruppe.
CellCept is not recommended for use in children after heart or liver transplants because of a lack of information on its effects in this group.
Det kan være nødvendigt at tilpasse dosis hos patienter med lever - eller nyresygdomme.
The dose may need to be adjusted in patients with liver or kidney disease.
Der er flere oplysninger i produktresuméet (også en del af denne EPAR).
For more information, see the Summary of Product Characteristics (also part of the EPAR).
Reproduction is authorised provided the source is acknowledged Hvordan virker CellCept?
Reproduction is authorised provided the source is acknowledged. lymphocytes (a type of white blood cell which is involved in the rejection of organ transplants).
Det aktive stof i CellCept, mycophenolatmofetil, er et immunsupprimerende lægemiddel.
By preventing the production of new DNA, CellCept reduces the rate at which the lymphocytes multiply.
CellCept virker ved at forhindre produktionen af nyt dna og reducerer derigennem hastigheden, hvormed lymfocytterne formerer sig.
This makes them less effective at recognising and attacking the transplanted organ, lowering the risk of the organ being rejected.
CellCept- kapsler og - tabletter er blevet undersøgt i tre undersøgelser med 1. 493 voksne patienter, der havde fået foretaget en nyretransplantation, i én undersøgelse med 650 voksne patienter, der havde fået foretaget en hjertetransplantation, og i én undersøgelse med 565 voksne patienter, der havde fået foretaget en levertransplantation.
CellCept capsules and tablets have been studied in three studies involving a total of 1,493 adults following kidney transplant, in one study involving 650 adults following heart transplant and in one study involving 565 adults following liver transplant.
I undersøgelsen med hjertetransplanterede patienter oplevede cirka 38% af de patienter, der blev behandlet med CellCept, og dem, der blev behandlet med azathioprin, organafstødning efter seks måneder.
In the heart transplant study, around 38% of patients taking CellCept and those taking azathioprine experienced rejection after six months.
Af de patienter, der fik en levertransplantation, og som blev behandlet med CellCept, oplevede 38% afstødning af deres nye lever efter seks måneder sammenlignet med 48% af dem, der blev behandlet med azathioprin, men andelen af patienter, som oplevede afstødning af deres nye lever efter et år, var den samme i begge grupper, nemlig cirka 4%.
Following liver transplant, 38% of the patients taking CellCept had rejected their new liver after six months, compared with 48% of those taking azathioprine, but the proportion of patients who had lost their new liver after a year was similar in the two groups, at around 4%.
Den alvorligste risiko ved CellCept er den mulige udvikling af kræft, især lymfe - og hudkræft.
The most serious risk associated with CellCept is the possible development of cancer, particularly lymphoma and skin cancer.
De almindeligste bivirkninger ved CellCept givet i kombination med ciclosporin og kortikosteroider (som optræder hos flere end 1 ud af 10 patienter) er sepsis (blodforgiftning), candidiasis i mave - / tarmkanalen (en svampeinfektion), urinvejsinfektion, herpes simplex (en virusinfektion, der giver forkølelsessår), herpes zoster (en virusinfektion, der giver skoldkopper og helvedesild), leucopeni (nedsat antal hvide blodlegemer), trombocytopeni (nedsat antal blodplader), anæmi (blodmangel), opkast, mavesmerter, diarré og kvalme.
The most common side effects with CellCept used in combination with ciclosporin and corticosteroids (seen in more than 1 patient in 10) are sepsis (blood infection), gastrointestinal candidiasis (a fungal infection of the stomach or gut), urinary tract infection (infection of the structures that carry urine), herpes simplex (a viral infection that causes cold sores), herpes zoster (a viral infection that causes chickenpox and shingles), leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), vomiting, abdominal (tummy) pain, diarrhoea and nausea (feeling sick).
Den fuldstændige liste over de indberettede bivirkninger ved CellCept fremgår af indlægssedlen.
For the full list of side effects reported with CellCept, see the Package Leaflet.
CellCept bør ikke anvendes til behandling af patienter, der kan være overfølsomme (allergiske) over for mycophenolatmofetil eller mycophenolsyre.
CellCept should not be used in people who may be hypersensitive (allergic) to mycophenolate mofetil or mycophenolic acid.
Det bør heller ikke anvendes til behandling af kvinder, der ammer.
It should not be used in women are breast-feeding.
CellCept anbefales ikke til behandling af gravide kvinder, og behandlingen af en kvinde bør først påbegyndes, når der er foretaget en negativ graviditetstest, og kun hvis hun bruger en effektiv præventionsmetode før, under og i seks uger efter behandling med CellCept.
CellCept treatment is not recommended for use in pregnant women, and should only be started in women after a negative pregnancy test and if effective contraception is used before, during and for six weeks after CellCept treatment.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved CellCept i kombination med ciclosporin og kortikosteroider opvejer risiciene til forebyggelse af akut transplantatafstødning hos patienter, der har fået vævsfremmede nyre -, hjerte - eller levertransplantater.
The Committee for Medicinal Products for Human Use (CHMP) decided that CellCept’ s benefits are greater than its risks in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Udvalget anbefalede udstedelse af markedsføringstilladelse for CellCept.
The Committee recommended that CellCept be given marketing authorisation.
2/ 3 Andre oplysninger om CellCept:
Other information about CellCept:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for CellCept til Roche Registration Limited den 14. februar 1996.
The European Commission granted a marketing authorisation valid throughout the European Union for CellCept to Roche Registration Limited on 14 February 1996.
Den fuldstændige EPAR for CellCept findes her.
The full EPAR for CellCept can be found here.
Dette sammendrag blev sidst ajourført i 02- 2008.
2/ 3 This summary was last updated in 02-2008.
Blister (PVC/ Alu)
Oral use Blister (PVC/ Alu)
Blister (PVC/ Alu)
Blister (PVC/ Alu)
Pulver til koncentrat til
Powder for concentrate for solution for infusion
infusionsvæske, opløsning anvendelse EU/ 1/ 96/ 005/ 006
EU/ 1/ 96/ 005/ 006
Flaske (HPDE) 110 g
110 g
tabletter
Tablet
CellCept kapsler: aflang, blå/ brun, mærket med "CellCept 250" i sort på kapslens "hoved" og "Firmalogo" på kapslens "krop".
CellCept capsules: oblong, blue/ brown, branded with black "CellCept 250" on the capsule cap and "Company logo" on the capsule body.
CellCept er, i kombination med ciclosporin og kortikosteroider, indiceret til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre -, hjerte -, eller levertransplantater.
CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Anvendelse i forbindelse med nyretransplantation:
Use in renal transplant:
Oralt CellCept bør gives indenfor 72 timer efter transplantation.
Adults: oral CellCept should be initiated within 72 hours following transplantation.
Den anbefalede dosis af mycophenolatmofetil er 600 mg/ m2 oralt to gange daglig (højst 2 g daglig).
Children and adolescents (aged 2 to 18 years): the recommended dose of mycophenolate mofetil is 600 mg/ m2 administered orally twice daily (up to a maximum of 2 g daily).
CellCept- kapsler må kun ordineres til patienter med en legemsoverflade på mindst 1, 25 m2.
CellCept capsules should only be prescribed to patients with a body surface area of at least 1.25 m2.
Til patienter med en legemsoverflade på 1, 25- 1, 5 m2 kan der ordineres CellCept- kapsler i en dosis på 750 mg to gange daglig (daglig dosis:
Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed CellCept capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Til patienter med en legemsoverflade > 1, 5 m2 kan der ordineres CellCept- kapsler i en dosis på 1 g to gange daglig (daglig dosis:
Patients with a body surface area greater than 1.5 m2 may be prescribed CellCept capsules 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 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.
For børn under 2 år er der begrænsede data om sikkerhed og effekt.
Children (< 2 years): there are limited safety and efficacy data in children below the age of 2 years.
Anvendelse i forbindelse med hjertetransplantation:
Use in cardiac transplant:
Oralt CellCept bør gives indenfor 5 døgn efter transplantation.
Adults: oral CellCept should be initiated within 5 days following transplantation.
Den anbefalede dosis til hjertetransplanterede patienter er 1, 5 g administreret to gange daglig (døgndosis, 3 g).
The recommended dose in cardiac transplant patients is 1.5 g administered twice daily (3 g daily dose).
Der er ingen data vedrørende hjertetransplantationer hos børn.
2 Use in hepatic transplant:
2 Voksne:
Adults:
Den anbefalede orale CellCept dosis til levertransplanterede patienter er 1, 5 g to gange daglig (en døgndosis på 3 g).
The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Der er ingen data vedrørende levertransplantationer hos børn.
Children: no data are available for paediatric hepatic transplant patients.
Den anbefalede dosering på 1 g administreret to gange daglig til nyretransplanterede patienter og 1, 5 g administreret to gange daglig til hjerte - eller levertransplanterede patienter er passende til ældre.
Use in elderly (≥ 65 years): 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 nyreinsufficiens (glomerulær filtration < 25 ml• min- 1• 1, 73 m- 2), bortset fra den umiddelbare post- transplantationsperiode, bør doser på mere end 1 g administreret to gange dagligt undgås.
Use in renal impairment: in renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 ml• min-1• 1.73 m-2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
Der findes ingen tilgængelige data for hjerte - eller levertransplanterede patienter med svær, kronisk nyreinsufficiens.
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Det er ikke nødvendigt med dosisjusteringer hos patienter med svær leverparenchymlidelse.
Use in severe hepatic impairment: no dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Der findes ingen tilgængelige data for hjertetransplanterede patienter med svær leverparenchymsygdom.
No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Behandling under afstødningsepisoderne:
Treatment during rejection episodes:
MPA (mycophenolsyre) er den aktive metabolit af mycophenolatmofetil.
MPA (mycophenolic acid) is the active metabolite of mycophenolate mofetil.
Nyretransplantatafstødning medfører ingen ændringer af MPA’ s farmakokinetik; dosisreduktion eller afbrydelse af CellCept er ikke nødvendig.
Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of CellCept is not required.
Der er ikke grundlag for justering af CellCept- dosis efter afstødning af hjertetransplantat.
There is no basis for CellCept dose adjustment following cardiac transplant rejection.
Der er observeret hypersensitivitetsreaktioner over for CellCept (se pkt.
Hypersensitivity reactions to CellCept have been observed (see section 4.8).
Derfor er CellCept kontraindiceret hos patienter med hypersensitivitet over for mycophenolatmofetil og mycophenolsyre.
Therefore, CellCept is contraindicated in patients with a hypersensitivity to mycophenolate mofetil or mycophenolic acid.
4. 6).
CellCept is contraindicated in women who are breastfeeding (see section 4.6).
4. 6.
For information on use in pregnancy and contraceptive requirements see section 4.6.
4. 8).
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including CellCept, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8).
Risikoen synes snarere at være relateret til intensiteten og varigheden af immunosuppression end til brugen af et bestemt middel.
The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.
For at minimere risikoen for hudkræft må det generelt tilrådes, at udsættelse for sollys og 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 UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Patienter, som får CellCept, skal have besked om straks at indberette alle tegn på infektion, uventede blodudtrækninger, blødning eller andre manifestationer af knoglemarvsdepression.
Patients receiving CellCept should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
4. 8).
Patients treated with immunosuppressants, including CellCept, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Blandt de opportunistiske infektioner er BK- virus associeret med nefropati og JC- virus associeret med progressiv multifokal leukoencefalopati (PML).
Among the opportunistic infections are BK virus associated nephropathy and JC virus associated progressive multifocal leukoencephalopathy (PML).
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 in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
3 Patienter, der får CellCept, bør monitoreres for neutropeni, som kan relateres til CellCept, samtidig medicin, virale infektioner eller en eller anden kombination af disse årsager.
3 Patients receiving CellCept should be monitored for neutropenia, which may be related to CellCept itself, concomitant medications, viral infections, or some combination of these causes.
Hvis der optræder neutropeni (det absolutte neutrofillocyttal < 1, 3 x 103/ μl), skal behandlingen med CellCept måske afbrydes eller stoppes.
If neutropenia develops 3 (absolute neutrophil count < 1.3 x 10 / µl), it may be appropriate to interrupt or discontinue CellCept.
4. 5).
Patients should be advised that during treatment with CellCept, vaccinations may be less effective and the use of live attenuated vaccines should be avoided (see section 4.5).
Eftersom CellCept er blevet sat i forbindelse med en øget incidens af bivirkninger i fordøjelsessystemet inklusive sjældne tilfælde af ulceration, blødning og perforation bør CellCept administreres med forsigtighed til patienter med aktiv alvorlig sygdom i fordøjelsessystemet.
Because CellCept has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation, CellCept should be administered with caution in patients with active serious digestive system disease.
CellCept er en IMPDH- hæmmer (inosinmonofosfatdehydrogenase- hæmmer).
CellCept is an IMPDH (inosine monophosphate dehydrogenase) 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.
CellCept bør ikke administreres samtidig med azathioprin, da en sådan samtidig administration ikke er blevet undersøgt.
It is recommended that CellCept should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
I betragtning af colestyramins signifikante reduktion af MPA- AUC skal man på grund af risikoen for at reducere virkningen af CellCept være forsigtig med samtidig administration af CellCept og lægemidler, som interfererer med det enterohepatiske kredsløb.
In view of the significant reduction in the AUC of MPA by cholestyramine, caution should be used in the concomitant administration of CellCept with medicinal products that interfere with enterohepatic recirculation because of the potential to reduce the efficacy of CellCept.
4. 5).
The risk: benefit of mycophenolate mofetil in combination with tacrolimus or sirolimus has not been established (see also section 4.5).
Der blev observeret højere aciclovir plasmakoncentrationer, når mycophenolatmofetil blev administreret sammen med aciclovir sammenlignet med administration af aciclovir alene.
Aciclovir: higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered with aciclovir in comparison to the administration of aciclovir alone.
Ændringerne i MPAGs (MPAs phenoliske glucuronid) farmakokinetik (MPAG steg med 8%) var minimale og anses ikke for klinisk signifikante.
The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8%) were minimal and are not considered clinically significant.
Da MPAG- plasmakoncentrationer forhøjes ved tilstedeværelse af nyreinsufficiens, ligesom aciclovir- koncentrationerne bliver det, er der en mulighed for, at mycophenolatmofetil og aciclovir, eller dets 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.
Antacids with magnesium and aluminium hydroxides: absorption of mycophenolate mofetil was decreased when administered with antacids.
4. 4 og pkt.
Cholestyramine: following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g 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. risikoen for nedsat effekt af CellCept.
Caution should be used during concomitant administration because of the potential to reduce efficacy of CellCept.
Der skal iagttages forsigtighed med lægemidler, som interfererer med den enterohepatiske cirkulation pga. risikoen for nedsat effekt af CellCept.
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 CellCept.
Ciclosporin A' s (CsA) farmakokinetik påvirkes ikke af mycophenolatmofetil.
4 Ciclosporin A: ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
30% forventes, hvis samtidig ciclosporinbehandling seponeres.
In contrast, if concomitant ciclosporin treatment is stopped, an increase in MPA AUC of around 30% should be expected.
Baseret på resultaterne fra en undersøgelse med enkeltdosisindgift af anbefalede doser af oral mycophenolatmofetil og i. v. ganciclovir og de kendte virkninger af nedsat nyrefunktion på CellCept’ s 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 IV ganciclovir and the known effects of renal impairment on the pharmacokinetics of CellCept (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 CellCept er ikke nødvendig.
No substantial alteration of MPA pharmacokinetics is anticipated and CellCept dose adjustment is not required.