FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you take CellCept
Danish: Det skal du vide, før du begynder at tage CellCept
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere oplysninger om CellCept findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: • They are available as packs of 50 (in blister packs of 10) or Multipacks containing 150 (3 packs of 50) tablets.
Danish: • De findes i pakninger med 50 (blisterpakninger a 10 stk.) eller multipakninger indeholdende
English: 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).
Danish: 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.
English: Female patients of childbearing potential should be made aware of the risks and follow the recommendations provided in section 4.6 (e.g. contraceptive methods, pregnancy testing) prior to, during, and after therapy with CellCept.
Danish: 4.6 (f.eks. prævention, graviditetstests) før, under og efter behandling med CellCept.
English: • CellCept tablets: microcrystalline cellulose, polyvidone (K-90), croscarmellose sodium,
Danish: • CellCept tabletter: Mikrokrystallinsk cellulose, polyvidon (K-90), croscarmellosenatrium, magnesiumstearat
English: Immune system disorders Hypersenstivity
Danish: Immunsystemet Hypersensitivitet
English: Venous thrombosis
Danish: Venetrombose
English: In some of these cases switching CellCept to another immunosuppressant resulted in improvement in respiratory symptoms.
Danish: I nogle af disse tilfælde sås forbedringer i de respiratoriske symptomer, når Cellcept blev erstattet af alternative immunsuppressiva.
English: NAME OF THE MEDICINAL PRODUCT CellCept 250 mg capsules.
Danish: LÆGEMIDLETS NAVN CellCept 250 mg kapsler.
English: 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 (see section 4.4, and section 5.2).
Danish: Efter enkeltdosis oral 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.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains the equivalent of 500 mg mycophenolate mofetil (as hydrochloride salt).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 500 mg mycophenolatmofetil (som hydrochlorid).
English: • Abnormalities of the ear (e.g. abnormally formed or absent externalear), external auditory canal atresia (middle ear);
Danish: • abnormiteter i ørerne (f.eks. abnormt formet eller manglende ydre øre), tillukning af øregangen
English: Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
Danish: Hver flaske indeholder 35 g mycophenolatmofetil i 110 g pulver til oral suspension.
English: Mean plasma MPAG AUC0-12h was 2 - 3-fold higher than in post-transplant patients without delayed graft function.
Danish: Middelværdien for plasma-MPAG-AUC0-12 timer var 2-3 gange højere end hos post-transplanterede patienter uden forsinket transplantatfunktion.
English: Holding onto the body of the dispenser, carefully pull the dispenser out of the bottle adapter.
Danish: • Hold godt omkring selve dispenseren og træk dispenseren langsomt ud af flaskeadaptoren.
English: • Do not use the capsules after the expiry date stated on the carton (EXP).
Danish: • Brug ikke CellCept efter den udløbsdato, der står på pakningen efter EXP.
English: Female patients of reproductive potential must be made aware of the increased risk of pregnancy loss and congenital malformations at the beginning of the treatment and must be counseled regarding pregnancy prevention and planning.
Danish: Når behandlingen initieres, skal fertile kvinder informeres om den øgede risiko for abort og medfødte misdannelser, og de skal vejledes omkring prævention og graviditetsplanlægning.
English: The recommended dose of 1 g administered twice a day for renal or hepatic transplant patients is appropriate for the elderly.
Danish: Den anbefalede dosis på 1 g administreret to gange daglig til nyre- eller levertransplanterede patienter er passende til ældre.
English: The systemic exposure at this dose was approximately 0.5 times the clinical exposure at the recommended clinical dose of 2 g/day.
Danish: Den systemiske eksponering af denne dosis var ca. 0,5 gange den kliniske eksponering af den anbefalede kliniske dosis på 2 g daglig.
English: Skin problems such as: acne, cold sores, shingles, skin growth, hair loss, rash, itching.
Danish: Hudlidelser såsom: • akne, forkølelsessår, helvedesild (herpes zoster), øget hudvækst, hårtab, udslæt, kløe.
English: The contents of CellCept 500 mg powder for concentrate for solution for infusion vials must be reconstituted with 14 mL of glucose intravenous infusion 5% each.
Danish: Indholdet af hvert hætteglas med CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, skal rekonstitueres med 14 ml 5 % glucoseinfusionsvæske.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/005/006 CellCept (1 bottle 110g)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/96/005/006 CellCept (1 flaske 110 g)
English: Reconstituted solution and infusion solution: If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 3 hours from reconstitution and dilution of the medicinal product.
Danish: Hvis infusionsopløsningen ikke er fremstillet umiddelbart før administrationen skal infusion af infusionsopløsningen påbegyndes senest 3 timer efter fremstillingen og opløsning af lægemidlet.
English: (150 (3x50) tablets multipack)
Danish: 150 (3 pakker af 50) tabletter.
English: Drugs which interfere with MPA's enterohepatic cycle (e.g. cholestyramine, antibiotics) should be used with caution due to their potential to reduce the plasma levels and efficacy of CellCept (see also section 4.5).
Danish: Lægemidler som påvirker MPAs enterohepatiske kredsløb (f.eks. colestyramin, antibiotika) bør anvendes med forsigtighed, da de potentielt kan reducere plasmaniveauet og virkningen af CellCept (se også pkt.
English: The first dose is given within 5 days of the transplant operation.
Danish: • Den første dosis gives inden for 5 dage efter transplantationen.
English: • The active substance is mycophenolate mofetil.
Danish: • Aktivt stof: Mycophenolatmofetil.
English: 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.
Danish: Den i dyre-carcinogenicitetsstudier højest testede dosis resulterede i ca. 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.
English: Discard the vial if particulate matter or discoloration is observed.
Danish: Hætteglasset bortkastes, hvis der ses partikler eller misfarvning.
English: When comparing rates of transplant rejection, rates of graft loss or adverse event profiles between CellCept patients with and without concomitant telmisartan medication, no clinical consequences of the pharmacokinetic drug-drug interaction were seen.
Danish: Der blev ikke set kliniske konsekvenser af de farmakokinetiske lægemiddelinteraktioner ved sammenligning af hyppigheden af afstødning af transplantat eller tab af transplantat eller bivirkningsprofilen mellem Cellcept-patienter med og uden samtidig telmisartan-medicinering.
English: Capsule shells gelatin indigo carmine (E132) yellow iron oxide (E172) red iron oxide (E172) titanium dioxide (E171) black iron oxide (E172) potassium hydroxide shellac.
Danish: Kapselskaller gelatine indigotin (E132) gul jernoxid (E172) rød jernoxid (E172) titandioxid (E171) sort jernoxid (E172) kaliumhydroxid shellac
English: Severe hepatic impairment No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Danish: Svært nedsat leverfunktion Dosisjustering er ikke nødvendig hos nyretransplanterede patienter med svær leverparenkymlidelse.
English: Hyperlipidemia
Danish: Hyperkaliæmi
English: • The shelf-life of the reconstituted suspension is two months.
Danish: • Holdbarheden af den blandede suspension er 2 måneder.
English: NAME OF THE MEDICINAL PRODUCT CellCept 1 g/5 ml powder for oral suspension.
Danish: LÆGEMIDLETS NAVN CellCept 1 g/5 ml pulver til oral suspension.
English: Congenital malformations have been observed post-marketing in children of patients exposed to CellCept in combination with other immunosuppressants, see section 4.6.
Danish: Efter markedsføring er der blevet observeret medfødte misdannelser hos børn af patienter, der har været eksponeret for CellCept i kombination med andre immunsuppressiva (se pkt.
English: 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).
Danish: Til patienter med en legemsoverflade > 1,5 m2 kan der ordineres CellCept-kapsler i en dosis på 1 g to gange daglig (daglig dosis: 2 g).
English: Hypocalcemia
Danish: Hypocalcæmi
English: CellCept 500 mg powder for concentrate for solution for infusion is available in packs containing 4 vials.
Danish: CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, findes i pakninger med 4 hætteglas.
English: Lymphoproliferative disorder
Danish: Lymfoproliferativ sygdom
English: The daily dose is 2 g of the medicine taken as 2 separate doses.
Danish: • Den daglige dosis er 2 g af medicinen indtaget som 2 separate doser.
English: 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 4.4).
Danish: Patienter der får immunsuppressiv behandling med kombinationer af lægemidler, inklusiv CellCept, har forhøjet risiko for at udvikle lymfomer og andre maligniteter, særligt i huden (se pkt.
English: There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving CellCept in combination with other immunosuppressants.
Danish: Der er rapporteret hypogammaglobulinæmi i forbindelse med tilbagevendende infektioner hos patienter, der har fået CellCept i kombination med andre immunsuppressiva.
English: 5 mL of the reconstituted suspension contains 1 g of mycophenolate mofetil.
Danish: 5 ml af den rekonstituerede suspension indeholder 1 g mycophenolatmofetil.
English: The most common opportunistic infections in patients receiving CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials in renal, cardiac and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/syndrome and Herpes simplex.
Danish: I kontrollerede kliniske studier hos nyre-, 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.
English: Very Common Uncommon
Danish: Meget almindelig Ikke almindelig
English: Paediatric population No data are available for paediatric hepatic transplant patients.
Danish: Pædiatrisk population Der er ingen data vedrørende levertransplantationer hos pædiatriske patienter.
English: 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.
Danish: Den anbefalede dosis på 1 g to gange daglig til nyretransplanterede patienter og 1,5 g to gange daglig til hjerte- eller levertransplanterede patienter er passende til ældre.
English: The most common opportunistic infections in patients receiving CellCept (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials in renal and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/syndrome and Herpes simplex.
Danish: I kontrollerede kliniske studier hos nyre- 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.
English: NAME OF THE MEDICINAL PRODUCT CellCept 1 g/5 ml powder for oral suspension mycophenolate mofetil
Danish: LÆGEMIDLETS NAVN CellCept 1 g/5 ml pulver til oral suspension mycophenolatmofetil
English: • Each bottle of 110 g powder for oral suspension contains 35 g of mycophenolate mofetil. Reconstitute with 94 mL of purified water.
Danish: • Hver flaske med 110 g pulver til oral suspension indeholder 35 g mycophenolatmofentil.
English: 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).
Danish: CellCept-kapsler må kun ordineres til patienter med en legemsoverflade på mindst 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: 1,5 g).
English: CellCept 500 mg powder for concentrate for solution for infusion
Danish: CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning
English: How to take CellCept
Danish: Sådan skal du tage CellCept
English: NAME OF THE MEDICINAL PRODUCT CellCept 500 mg film-coated tablets.
Danish: LÆGEMIDLETS NAVN CellCept 500 mg filmovertrukne tabletter.
English: Therefore, women with childbearing potential must use at least one form of reliable contraception (see section 4.3) before starting CellCept therapy, during therapy, and for six weeks after stopping the therapy, unless abstinence is the chosen method of contraception.
Danish: 4.3), inden behandling med CellCept påbegyndes, under behandlingen og i seks uger efter behandlingsophør, medmindre seksuel afholdenhed er den valgte form for prævention.
English: Swallow your capsules whole with a glass of water Do not break or crush them
Danish: Synk kapslerne hele med et glas vand
English: The full name of your medicine is CellCept 500 mg powder for concentrate for solution for infusion.
Danish: Medicinens fulde navn er CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning.
English: 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.
Danish: Da MPAG-plasmakoncentrationer forhøjes ved nedsat nyrefunktion, 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.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 February 1996
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION CellCept 1 g/5 ml powder for oral suspension mycophenolate mofetil
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) CellCept 1 g/5 ml pulver til oral suspension mycophenolatmofetil
English: The shelf-life of the reconstituted suspension is 2 months.
Danish: Holdbarheden af den rekonstituerede orale suspension er 2 måneder.
English: Cardiac disorders Tachycardia
Danish: Hjerte Takykardi
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION CellCept 500 mg powder for concentrate for solution for infusion mycophenolate mofetil
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning mycophenolatmofetil
English: There is no information for the use of CellCept in children with a heart transplant.
Danish: Børn • Der er ingen information om brug af CellCept til hjertetransplanterede børn.
English: In some of these cases switching CellCept to an alternative immunosuppressant resulted in serum IgG levels returning to normal.
Danish: I nogle af disse tilfælde blev serum-IgG normaliseret, når Cellcept blev erstattet af alternative immunsuppressiva.
English: Very Common Very Common Very Common
Danish: Meget almindelig Meget almindelig Meget almindelig
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacture(s) responsible for batch release CellCept 500 mg powder for concentrate for solution for infusion CellCept 1 g/5 ml powder for oral suspension: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Germany.
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse - CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning - CellCept 1 g/5 ml pulver til oral suspension:
English: Blood lactate dehydrogenase increased
Danish: Forhøjet laktatdehydrogenase
English: 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.
Danish: 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.
English: 5 mL of the reconstituted suspension contain 1 g of mycophenolate mofetil.
Danish: 5 ml af den rekonstituerede suspension indeholder 1 g mycophenolatmofentil.
English: • The daily dose is 15 mL suspension (3 g of the medicine) taken as 2 separate doses.
Danish: • Den daglige dosis er 15 ml suspension (3 g af medicinen) indtaget som 2 separate doser.
English: (mycophenolate mofetil)
Danish: mycophenolatmofetil.
English: 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.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Da mycophenolatmofetil har udvist fosterbeskadigende virkning hos rotter og kaniner, skal inhalation undgås og undgå, at hud og slimhinder kommer i direkte kontakt med det tørre pulver og undgå, at hud kommer i direkte kontakt med den rekonstituerede suspension.
English: 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.
Danish: Ældre patienter som får CellCept som led i et immunsuppressivt kombinationsregime, kan have større risiko for visse infektioner (inklusive vævsinvasiv sygdom forårsaget af cytomegalovirus) og muligvis gastrointestinal blødning og lungeødem, sammenlignet med yngre individer.
English: Medicinal products that affect glucuronidation (e.g. isavuconazole, telmisartan) Concomitant administration of drugs affecting glucuronidation of MPA may change MPA exposure.
Danish: Samtidig administration af lægemidler, der påvirker glukuronidering af MPA, kan ændre MPAeksponeringen.
English: 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.
Danish: mycophenolatmofetil oralt to gange daglig, var typen og hyppigheden af bivirkninger generelt den samme som dem, der observeredes hos voksne patienter, som fik 1 g CellCept to gange daglig.
English: 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.
Danish: 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.
English: There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated with CellCept in combination with other immunosuppressants, some of which have been fatal.
Danish: Der er rapporteret om enkelte tilfælde af interstitiel lungesygdom og lungefibrose hos patienter, som fik Cellcept i kombination med andre immunsuppressiva.
English: 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.
Danish: Den i dyre-carcinogenicitetsstudier højest testede dosis resulterede i ca. 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.
English: Hypogammaglobulinaemia has been reported in patients receiving CellCept in combination with other immunosuppressants.
Danish: Hypogammaglobulinæmi er rapporteret hos patienter, der har fået Cellcept i kombination med andre immunsuppressiva.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous infusion only Reconstitute and dilute before use Read the package leaflet before use
Danish: Rekonstituer og fortynd før brugen Læs indlægssedlen inden brug
English: Contents of the pack and other information What CellCept film coated tablet contains
Danish: CellCept filmovertrukne tabetter indeholder:
English: NAME OF THE MEDICINAL PRODUCT CellCept 250 mg capsules mycophenolate mofetil
Danish: LÆGEMIDLETS NAVN CellCept 250 mg kapsler mycophenolatmofetil
English: When comparing rates of transplant rejection or rates of graft loss between CellCept patients taking PPIs vs. CellCept patients not taking PPIs, no significant differences were seen.
Danish: Der blev ikke set signifikante forskelle i hyppigheden af afstødning eller tab af transplantat hos Cellcept-patienter, som tog protonpumpehæmmer versus Cellcept-patienter, som ikke tog protonpumpehæmmer.
English: The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94% relative to IV mycophenolate mofetil. Food had no effect on the extent of absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5 g BID to renal transplant patients.
Danish: Føde har ingen effekt på absorptionen (MPA-AUC) af mycophenolatmofetil, når det gives i doser på 1,5 g to gange daglig til nyretransplanterede patienter.
English: However, keep taking CellCept until you see him or her.
Danish: Fortsæt dog behandlingen, indtil du ser lægen.