natgillin/translations-raw huggingface dataset:
Patienter, som får CellCept, skal have foretaget fuldstændig blodtælling hver uge i den første måned, to gange månedligt i anden og tredje behandlingsmåned og derefter månedligt i det første år 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.
Da CellCept er blevet sat i forbindelse med forhøjet incidens af bivirkninger i fordøjelsessystemet inklusive sjældne tilfælde af ulceration, blødning og perforation i mavetarmkanalen, bør CellCept administreres med forsigtighed til patienter med alvorlig, 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 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 samtidigt med azathioprin, da en sådan samtidig administration ikke er 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 ar 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.
CellCept 1 g/ 5 ml pulver til oral suspension indeholder aspartam.
CellCept 1 g/ 5 ml powder for oral suspension contains aspartame.
6. 1).
Therefore, care should be taken if CellCept 1 g/ 5 ml powder for oral suspension is administered to patients with phenylketonuria (see section 6.1)
Da MPAG- plasmakoncentrationer forhøjes ved tilstedeværelse af nyreinsufficiens, lige som aciclovir- koncentrationerne bliver det, er der en mulighed for, at mycophenolatmofetil og aciclovir, eller dets prodrugs, f. eks. valaciclovir, vil konkurrere om den renale tubulære sekretion, og 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.
Efter enkeltdosis- administration af 1, 5 g mycophenolatmofetil til normale, sunde personer forbehandlet med 4 g colestyramin tre gange daglig i 4 dage var der en 40% reduktion af
28 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.
4. 2) forventes det at samtidig administration af disse stoffer (som konkurrerer om mekanismerne for renal tubulær sekretion) vil resultere i stigninger af MPAG - og ganciclovirkoncentrationerne.
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.
Dosisrekommendationerne for ganciclovir skal iagttages hos patienter med nyreinsufficiens til hvem CellCept og ganciclovir, eller dets prodrugs, f. eks. valganciclovir, gives samtidigt, og patienterne bør kontrolleres 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.
29 Levende vacciner:
Thus, other substances known to undergo renal tubular secretion 29 may compete with MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular secretion.
Alle transplanterede patienter har forhøjet risiko for at få opportunistiske infektioner, og risikoen øges med stigende immunsuppressiv belastning (se pkt.
All transplant patients are at increased risk of opportunistic infections; the risk increased with total immunosuppressive load (see section 4.4).
I kontrollerede kliniske studier hos nyre - (2 g data), hjerte - og levertransplanterede patienter, som blev fulgt i mindst 1 år, var de almindeligste opportunistiske infektioner hos patienter, som fik CellCept (2 g eller 3 g daglig) sammen med andre immunsupprimerende stoffer, mukokutane candidainfektioner, CMV- viræmi/ syndrom og herpes simplex- infektioner.
The most common opportunistic infections in patients receiving CellCept (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
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
The type and frequency of adverse reactions in a clinical study, which recruited 92 paediatric patients aged 2 to 18 years who were given 600 mg/ m2 mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g CellCept twice daily.
Ældre patienter, som får CellCept som led i et kombinationsimmunsuppressivt 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 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.
Infektioner og
Adverse drug reactions
parasitære sygdomme
Infections and infestations
almindelig Almindelig
Very common Common
simplex, herpes zoster Pneumoni, influenza, infektion i luftrøret, respiratorisk moniliasis, gastrointestinal infektion, candidiasis, gastroenteritis, infektion, bronkitis, pharyngitis, sinuitis, svampeinfektion i huden, hud candidiasis, vaginal candidiasis, rhinitis
Sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
Benigne, maligne
Neoplasms benign, malignant and unspecified (incl cysts and
tumorer (inkl. cyster og polypper)
polyps) Blood and lymphatic system disorders
Almindelig
Common Very common Common
Hudkræft, benignt neoplasme af huden
Skin cancer, benign neoplasm of skin Leucopenia, thrombocytopenia, anaemia Pancytopenia, leucocytosis
Meget almindelig Almindelig
Metabolism and nutrition disorders
Kramper, hypertoni, tremor, somnolens, muskelsvaghed, svimmelhed, hovedpine, paræstesier, smagsforstyrrelser
- Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
Hjerte
Psychiatric disorders
almindelig
Common
Takykardi
Common
Væskulære sygdomme
Cardiac disorders
- Hypotension, hypertension, vasodilatation
Tachycardia
Pleural effusion, dyspnø, hoste
- Pleural effusion, dyspnoea, cough
Mave - tarmkanalen
Gastrointestinal disorders
Opkastning, abdominalsmerter, diarré, kvalme Gastrointestinal blødning, peritonitis, ileus, colitis, mavesår, ulcus duodeni, gastritis, oesophagitis, stomatitis, obstipation, dyspepsi, flatulens, opstød
Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
- Hepatitis, icterus, hyperbilirubinæmi
Hepatitis, jaundice, hyperbilirubinaemia
- Hud hypertrofi, udslæt, acne, alopeci
- Skin hypertrophy, rash, acne, alopecia,
Knogler, led, muskler og
Musculoskeletal and connective Tissue disorders
bindevæv Nyrer og urinveje
- Arthralgia
Almindelig Meget almindelig
Renal and urinary disorders
Nedsat nyrefunktion
-
Almene symptomer og
Common
Forhøjede leverenzymer, forhøjet serum- creatinin, forhøjet laktatdehydrogenase, forhøjet serum- carbamid, forhøjede basiske phosphataser, vægttab
Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased
501 (2 g CellCept dagligt), 289 (3 g CellCept dagligt) og 277 (2 g i. v. / 3 g oral CellCept dagligt) patienter i fase III studier blev behandlet med henblik på forebyggelse af rejektion ved henholdsvis nyre -, hjerte - og levertransplantation.
501 (2 g CellCept daily), 289 (3 g CellCept daily) and 277 (2 g IV / 3 g oral CellCept daily) patients were treated in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively.
Mave- tarmkanalen: colitis inklusive cytomegalovirus colitis, (≥ 1/ 100 til < 1/ 10), pancreatitis, (≥ 1/ 100 til < 1/ 10) og intestinal villøs atrofi.
32 Gastrointestinal: colitis including cytomegaloviruscolitis, (≥ 1/ 100 to < 1/ 10), pancreatitis (≥ 1/ 100 to < 1/ 10) and intestinal villous atrophy.
Der har været indberetninger om
Agranulocytosis (≥ 1/ 1000 to < 1/ 100) and neutropenia have been reported; therefore regular monitoring of patients taking CellCept is advised (see section 4.4).
32 aplastisk anæmi og knoglemarvsdepression hos patienter behandlet med CellCept, hvor nogle har været fatale.
There have been reports of aplastic anaemia and bone marrow depression in patients treated with CellCept, some of which have been fatal.
Som godtgjort af suppression af akut afstødning efter nyretransplantation er CellCept’ s immunsuppressive aktivitet korreleret til koncentrationen af MPA.
As evidenced by suppression of acute rejection following renal transplantation, the immunosuppressant activity of CellCept is correlated with MPA concentration.
Mycophenolatmofetil kan ikke måles systemisk i plasma efter oral administration.
33 Mycophenolate mofetil is not measurable systemically in plasma following oral administration.
33 Ubetydelige mængder af stoffet udskilles som MPA (< 1% af dosis) i urinen.
A negligible amount of substance is excreted as MPA (< 1% of dose) in the urine.
Oralt administreret, radioaktivt mærket mycophenolatmofetil resulterede i fuldstændig genfinding af den administrerede dosis med 93% af den administrerede dosis genfundet i urinen og 6% genfundet i fæces.
Orally administered radiolabelled mycophenolate mofetil results in complete recovery of the administered dose, with 93% of the administered dose recovered in the urine and 6% recovered in the faeces.
I en enkeltdosisundersøgelse (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 < 25ml• 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 enkeltdosis 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 findes ingen data om hjerte - eller levertransplanterede patienter med svær kronisk nyreinsufficiens.
No data are available for cardiac or hepatic transplant patients with severe chronic renal impairment.
Hos patienter med forsinket renal transplantatfunktion post- transplantativt var middel MPA - AUC0- 12 timer sammenlignelig med, hvad man så hos posttransplanterede 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 - transplanterede patienter 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. sJustering af CellCept- dosis er ikke nødvendig.
Dose adjustment of CellCept does not appear to be necessary.
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.
Ældre patienter (≥ 65 år):
34 Elderly patients (≥ 65 years):
34 5. 3 Prækliniske sikkerhedsdata
5.3 Preclinical safety data
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) der er observeret hos hjertetransplanterede patienter 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 at the recommended clinical dose of 2 g/ day and 1.3 – 2 times the systemic exposure (AUC or Cmax) observed in cardiac transplant patients at the recommended clinical dose of 3 g/ day.
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 til 3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 2 g daglig hos nyretransplanterede patienter og 1, 3 - 2 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g daglig hos 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 af den anbefalede kliniske dosis på 3 g daglig hos 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.
0, 3 gange den kliniske eksponering ved den anbefalede dosis på 3 g daglig 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.
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 nyretransplantatrecipienter.
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.
Den ikke- kliniske toksikologiske profil af mycophenolatmofetil forekommer i overenstemmelse med bivirkninger observerede i de humane kliniske undersøgelser som nu fremviser bivirkningsdata der er mere relevante for en patientpopulation (se pkt.
The nonclinical toxicity profile of mycophenolate mofetil appears to be consistent with adverse events observed in
4. 8).
35 human clinical trials which now provide safety data of more relevance to the patient population (see section 4.8).
CellCept 1 g/ 5 ml pulver til oral suspension: sorbitol silica, kolloid, vandfri natriumcitrat sojabønnelecithin blandet frugtsmag
CellCept 1 g/ 5 ml powder for oral suspension: sorbitol silica, colloidal anhydrous sodium citrate soybean lecithin mixed fruit flavour xanthan gum aspartame* (E951) methyl parahydroxybenzoate (E218) citric acid anhydrous
* indeholder phenylalanin svarende til 2, 78 mg / 5 ml suspension.
* contains phenylalanine equivalent to 2.78 mg/ 5 ml of suspension.
Pulver til oral suspension og rekonstitueret oral suspension:
Powder for oral suspension and reconstituted suspension:
Hver flaske indeholder 110 g pulver til oral suspension.
Each bottle contains 110 g of powder for oral suspension.
Efter rekonstituering er suspensionens volumen 175 ml svarende til et nyttevolumen på 160- 165 ml.
When reconstituted, the volume of the suspension is 175 ml, providing a usable volume of 160 – 165 ml.
Da mycophenolatmofetil har demonstreret fosterbeskadigende virkning på rotter og kaniner, skal man undgå at det tørre pulver inhaleres eller kommer i direkte kontakt med hud og slimhinder, og at den rekonstituerede suspension kommer i direkte kontakt med huden.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, avoid inhalation or direct contact with skin or mucous membranes of the dry powder as well as direct contact of the reconstituted suspension with the skin.
Det anbefales at rekonstituere CellCept 1 g/ 5 ml pulver til oral suspension på apoteket før den udleveres til patienten.
It is recommended that CellCept 1 g/ 5 ml powder for oral suspension be reconstituted by the pharmacist prior to dispensing to the patient.
Mål 94 ml renset vand af i et målebæger.
Measure 94 ml of purified water in a graduated cylinder.
1 min.
Add approximately half of the total amount of purified water to the bottle and shake the closed bottle well for about 1 minute.
1 min.
Add the remainder of water and shake the closed bottle well for about 1 minute.
Roche Registration Limited, 6 Falcon Way Shire Park
Roche Registration Limited 6 Falcon Way Shire Park Welwyn Garden City AL7 1TW United Kingdom
EU/ 1/ 96/ 005/ 006 CellCept (1 flaske 110 g)
EU/ 1/ 96/ 005/ 006 CellCept
CellCept 500 mg tabletter.
CellCept 500 mg tablets.
CellCept tabletter: lille kappeformet, lavendelfarvet tablet, med "CellCept 500" præget på den ene side og "Firmalogo" på den anden.
CellCept tablets: lavender coloured caplet-shaped tablet, engraved with "CellCept 500" on one side and "Company logo" on the other.
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.
2 g).
CellCept 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).
Anvendelse ved levertransplantation:
Use in hepatic transplant:
38 Voksne:
38 Adults:
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.
39 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.
39 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 (absolute neutrophil count < 1.3 x 103/ µl), it may be appropriate to interrupt or discontinue CellCept.
Da MPAG plasmakoncentrationer forhøjes ved tilstedeværelse af nyreinsufficiens, lige som 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.
Efter enkeltdosis- administration af 1, 5 g mycophenolatmofetil 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 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).