natgillin/translations-raw huggingface dataset:
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.
Der er 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.
Forsinket renal transplantatfunktion:
Delayed renal graft function:
Hos patienter med forsinket renal transplantatfunktion post- transplantativt var middel MPA - AUC0- 12 timer sammenlignelig med, hvad man så hos posttransplantations- 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- AUC0- 12 timer var 2- 3 gange højere end hos post - transplantationspatienter uden forsinket transplantatfunktion.
Mean plasma MPAG AUC (0-12h) was 2 – 3-fold higher than in post-transplant patients without delayed graft function.
Der kan være en forbigående stigning i den frie fraktion og i koncentrationen af plasma- MPA hos patienter med forsinket renal transplantatfunktion.
There may be a transient increase in the free fraction and concentration of plasma MPA in patients with delayed renal graft function.
Justering af CellCept- dosis er ikke nødvendig.
Dose adjustment of CellCept does not appear to be necessary.
Imidlertid kan hepatisk sygdom med overvejende biliær skade som f. eks. primær biliær cirrhose vise en anden virkning.
However, hepatic disease with predominantly biliary damage, such as primary biliary cirrhosis, may show a different effect.
Farmakokinetiske parametre evalueredes hos 49 nyretransplanterede børn, som fik 600 mg/ m2 mycophenolatmofetil oralt to gange daglig.
Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients given 600 mg/ m2 mycophenolate mofetil orally twice daily.
Med denne dosis opnåedes MPA AUC værdier svarende til hos voksne, nyretransplanterede patienter, som fik 1 g CellCept 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 CellCept 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.
Ældre patienter (≥ 65 år):
Elderly patients (≥ 65 years):
Farmakokinetikken hos ældre er ikke systematisk undersøgt.
Pharmacokinetic behaviour of CellCept in the elderly has not been formally evaluated.
4. 5).
The pharmacokinetics of oral contraceptives were unaffected by coadministration of CellCept (see also section 4.5).
Et studie om samtidig administration af CellCept (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 immunosuppressiva) i 3 konsekutive menstruationscykler viste ingen klinisk relevant påvirkning af CellCept på den ovulationshæmmende virkning af de orale kontraceptiva.
A study of the coadministration of CellCept (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 immunosupressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of CellCept on the ovulation suppressing action of the oral contraceptives.
Den i dyre carcinogenicitetsundersøgelser højest testede dosis resulterede i ca.
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
2 - 3 gange den systemiske eksponering (AUC eller Cmax) der er observeret hos nyretransplanterede patienter der fik den anbefalede kliniske dosis på 2 g daglig og 1, 3 - 2 gange den systemiske eksponering (AUC eller Cmax) observeret hos hjertetransplanterede patienter der fik den anbefalede kliniske dosis på 3 g daglig.
10 times the systemic exposure (AUC or Cmax) observed in cardiac transplant patients at the recommended clinical dose of 3 g/ day.
To genotoksicitets tests (in vitro muselymfom test og in vivo museknoglemarvs- mikronucleus test) viste, at mycophenolatmofetil potentielt kan forårsage kromosomaberrationer.
Two genotoxicity assays (in vitro mouse lymphoma assay and in vivo mouse bone marrow micronucleus test) showed a potential of mycophenolate mofetil to cause chromosomal aberrations.
Det kan skyldes den farmakodynamiske effekt, dvs. hæmning af nukleotidsyntesen i sensitive celler.
These effects can be related to the pharmacodynamic mode of action, i. e. inhibition of nucleotide synthesis in sensitive cells.
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 nyretransplanterede patienter og 1, 3 - 2 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g daglig 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.
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, 3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g daglig 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.
Der var ingen tydelig påvirkning af fertilitets - og reproduktionsparametre hos moderdyrene og den følgende generation.
No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.
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• kg1• 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 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.
4. 6.
Refer to section 4.6.
De hæmopoietiske og lymfoide organsystemer var de første primære organer der blev afficeret i de toksikologiske undersøgelser der blev foretaget med mycophenolatmofetil på rotte, mus, hund og abe.
The haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey.
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.
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.
Gastrointestinale virkninger observeredes hos hunden ved systemiske niveauer lig med eller mindre end det kliniske niveau ved den anbefalede dosis.
Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose.
Dehydreringslignende gastrointestinale - og nyrepåvirkninger observeredes også hos abe ved de højeste doser (systemiske niveauer lig med eller større end kliniske niveauer).
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).
4. 8).
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).
CellCept kapsler: pregelatineret majsstivelse croscarmellosenatrium polyvidon (K- 90) magnesiumstearat
CellCept capsules: pregelatinised maize starch croscarmellose sodium polyvidone (K-90) magnesium stearate
11 Kapselskaller: gelatine indigotin (E132) gul jernoxid (E172) rød jernoxid (E172) titandioxid (E171) sort jernoxid (E172) kaliumhydroxid shellac
11 Capsule shells: gelatin indigo carmine (E132) yellow iron oxide (E172) red iron oxide (E172) titanium dioxide (E171) black iron oxide (E172) potassium hydroxide shellac.
1 pakning indeholder 300 kapsler (blisterkort med 10 kapsler).
1 carton contains 100 capsules (in blister packs of 10) 1 carton contains 300 capsules (in blister packs of 10)
Da mycophenolatmofetil har demonstreret fosterbeskadigende virkning på rotter og kaniner, må CellCept kapsler ikke åbnes eller knuses.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, CellCept capsules should not be opened or crushed.
Undgå inhalation og direkte kontakt med hud og slimhinder med pulveret i CellCept kapslerne.
Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in CellCept capsules.
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW Storbritannien.
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
EU/ 1/ 96/ 005/ 001 CellCept (100 kapsler) EU/ 1/ 96/ 005/ 003 CellCept (300 kapsler)
EU/ 1/ 96/ 005/ 001 CellCept EU/ 1/ 96/ 005/ 003 CellCept
14, februar, 1996 Dato for seneste fornyelse af tilladelsen:
14 February 1996 Date of latest renewal:
14, februar, 2006
14 February 2006
6. 6).
CellCept 500 mg powder for concentrate for solution for infusion must be reconstituted and further diluted with glucose intravenous infusion 5% prior to administration to the patient (see section 6.6).
CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, er, i kombination med ciclosporin og kortikosteroider, indiceret til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre - eller levertransplantater.
CellCept 500 mg powder for concentrate for solution for infusion is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal or hepatic transplants.
FORSIGTIGHEDSREGEL:
CAUTION:
OPLØSNING MÅ ALDRIG GIVES SOM EN HURTIG INJEKTION ELLER SOM EN BOLUSINJEKTION.
SOLUTION SHOULD NEVER BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION.
6. 6).
Following reconstitution to a concentration of 6 mg/ ml, CellCept 500 mg powder for concentrate for solution for infusion must be administered by slow intravenous infusion over a period of 2 hours by either a peripheral or a central vein (see section 6.6).
Den anbefalede dosis til nyretransplanterede patienter er 1 g to gange daglig (en døgndosis på 2 g).
Use in renal transplant: the recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Den anbefalede dosis CellCept til infusion til levertransplanterede patienter er 1 g to gange daglig (en døgndosis på 2 g).
Use in hepatic transplant: the recommended dose of CellCept for infusion in hepatic transplant patients is 1 g administered twice daily (2 g daily dose).
Den anbefalede orale CellCept dosis til levertransplanterede patienter er 1, 5 g to gange daglig (en døgndosis på 3 g).
The recommended dose of oral CellCept in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Der er ingen farmakokinetiske data for nyretransplanterede børn.
Use in children: safety and efficacy of CellCept for infusion in paediatric patients have not been established.
Der findes ingen data for levertransplanterede børn.
No pharmacokinetic data with CellCept for infusion are available for paediatric renal
14 Anvendelse til ældre (≥ 65 år):
14 transplant patients.
Den anbefalede dosis på 1 g administreret to gange daglig til nye - eller levertransplanterede patienter er passende til ældre.
No pharmacokinetic data are available for paediatric patients following hepatic transplants.
Anvendelse ved nyreinsufficiens:
Use in elderly (≥ 65 years): the recommended dose of 1 g administered twice a day for renal or hepatic transplant patients is appropriate for the elderly.
Hos nyretransplanterede patienter med svær, kronisk nyreinsufficiens (glomerulær filtrationsrate < 25 ml• min- 1• 1, 73 m- 2), bortset fra den umiddelbare post - transplantationsperiode, skal doser på mere end 1 g administreret to gange daglig 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.
5. 2).
No dose adjustments are needed in patients experiencing delayed renal graft function post-operatively (see section 5.2).
Der findes ingen data om levertransplanterede patienter med svær, kronisk nyreinsufficiens.
No data are available for hepatic transplant patients with severe chronic renal impairment.
Det er ikke nødvendigt med dosisjusteringer hos nyretransplanterede patienter med svær leverparenkymlidelse.
Use in severe hepatic impairment: no dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Rejektion af nyretransplantater medfører ikke 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 ingen grund til at justere dosis efter rejektion af levertransplantater.
No pharmacokinetic data are available during hepatic transplant rejection.
CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, er kontraindiceret hos patienter som er overfølsomme overfor polysorbat 80.
CellCept 500 mg powder for concentrate for solution for infusion is contraindicated in patients who are allergic to polysorbate 80.
4. 6.
For information on use in pregnancy and contraceptive requirements, see section 4.6.
Patienter, som får CellCept, skal have foretaget fuldstændig blodtælling ugentlig i den første måned, to gange månedligt i anden og tredje behandlingsmåned og derefter månedligt i det første år.
Patients taking CellCept should have complete blood counts weekly during the first month, twice monthly for the
Hvis der optræder neutropeni (det absolutte neutrofillocyttal < 1, 3 x 103/ μl), skal behandlingen med CellCept måske afbrydes eller stoppes.
If neutropenia develops (absolute neutrophil count < 1.3 x 103/ 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).
CellCept bør gives med forsigtighed til patienter svær, aktiv 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.
Af teoretiske grunde bør det derfor undgås til patienter med sjælden arvelig 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 phosphoribosyltransferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
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.
Efter intravenøs indgift af CellCept må der regnes med en vis enterohepatisk recirkulation.
Some degree of enterohepatic recirculation is anticipated following intravenous administration of CellCept.
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 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.
Efter enkeltdosis- administration af 1, 5 g mycophenolatmofetil oralt til normale, sunde personer forbehandlet med 4 g colestyramin tre gange daglig i 4 dage var der en 40% reduktion af MPA AUC (se pkt.
Cholestyramine: following single dose, oral 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.
4. 4 og pkt.
(see section 4.4, and section 5.2).
Ciclosporin A' s (CsA) farmakokinetik påvirkes ikke af mycophenolatmofetil.
Ciclosporin A: ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
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 16 CellCept dose adjustment is not required.
Hos patienter med nedsat nyrefunktion, som får CellCept og ganciclovir, eller dets prodrugs, f. eks. valganciclovir samtidig, bør dosisanbefalingerne for ganciclovir følges og patienterne bør monitoreres omhyggeligt.
In patients with renal impairment in which CellCept and ganciclovir or its prodrugs, e. g. valganciclovir, are co-administered, the dose recommendations for ganciclovir should be observed and patients should be monitored carefully.
20%, når flere CellCept- doser (1, 5 g to gange daglig) blev givet til patienter, som fik tacrolimus.
In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of CellCept (1.5 g BID) were administered to patients taking tacrolimus.
Antistofresponset overfor andre vacciner kan nedsættes.
Live vaccines: live vaccines should not be given to patients with an impaired immune response.
4. 4.
The antibody response to other vaccines may be diminished (see also section 4.4).
Effektiv antikonception skal anvendes før behandling med CellCept påbegyndes, under behandlingen og i seks uger efter behandlingsophør (se pkt.
Effective contraception must be used before beginning CellCept therapy, during therapy, and for six weeks following discontinuation of therapy (see section 4.5).
Anvendelse af CellCept anbefales ikke under graviditet og bør begrænses til tilfælde, hvor der ikke findes andre mere passende behandlinger.
The use of CellCept is not recommended during pregnancy and should be reserved for cases where no more suitable alternative treatment is available.
Medfødte misdannelser, herunder øremisdannelser (dvs. abnormt dannet, eller manglende ydre øre/ mellemøre), er imidlertid blevet rapporteret hos børn af patienter, som under graviditeten er blevet behandlet med CellCept i kombination med andre immunosuppressiva.
However, congenital malformations including ear malformations, i. e. abnormally formed or absent external/ middle ear, have been reported in children of patients exposed
Tilfælde af spontane aborter er set hos patienter, der blev behandlet med CellCept.
17 to CellCept in combination with other immunosuppressants during pregnancy.
Det vides ikke om dette stof udskilles i human mælk.
It is not known whether this substance is excreted in human milk.
Ældre patienter, som får CellCept som del af en immunsuppressiv kombinationsbehandling, har, sammenlignet med yngre patienter, højere risiko for visse infektioner (inklusiv invasiv vævssygdom forårsaget af cytomegalovirus) og muligvis for gastrointestinal blødning og lungeødem.
Elderly patients receiving CellCept 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.