FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of probenecid with mycophenolate mofetil in monkeys raises plasma AUC of MPAG by 3-fold.
Danish: Samtidig administration af probenecid og mycophenolatmofetil forhøjer MPAGs plasma-AUC 3 gange hos aber.
English: CellCept 1 g/5 ml powder for oral suspension contains aspartame.
Danish: CellCept 1 g/5 ml pulver til oral suspension indeholder aspartam.
English: 20 mL type I clear glass vials with grey butyl rubber stopper and aluminium seals with plastic flip-off caps.
Danish: 20 ml type I klare hætteglas med grå butylgummiprop og aluminiumhætte med plastikafrivningshætte.
English: Following intravenous administration, mycophenolate mofetil undergoes rapid and complete metabolism to the active metabolite, MPA.
Danish: Efter intravenøs administration metaboliseres mycophenolatmofetil hurtigt og fuldstændigt til den aktive metabolit, MPA.
English: However, in renal transplant patients, tacrolimus concentration did not appear to be altered by CellCept (see also section 4.4).
Danish: Hos nyretransplanterede patienter blev tacrolimuskoncentrationen imidlertid tilsyneladende ikke påvirket af CellCept (se også pkt.
English: They have “CellCept 500” engraved on one side and “ROCHE” on the other.
Danish: ”CellCept 500” er præget på den ene side og ”Roche” er præget på den anden.
English: Powder for oral suspension and reconstituted suspension: Do not store above 30 °C.
Danish: Pulver til oral suspension og rekonstitueret oral suspension: Må ikke opbevares ved temperaturer over 30 °C.
English: A reduction in the AUC of MPA of approximately 40% is associated with the co-administration of cholestyramine (4 g TID), indicating that there is a significant amount of enterohepatic recirculation.
Danish: En reduktion af MPAAUC på ca. 40 % er associeret til den samtidige administration af colestyramin (4 g tre gange daglig), hvilket indikerer, at der er en betragtelig enterohepatisk recirkulation.
English: All patients treated with immunosuppressants are at increased risk of bacterial, viral and fungal infections (some of which may lead to a fatal outcome), including those caused by opportunistic agents and latent viral reactivation.
Danish: Alle patienter, som bliver behandlet med immunsuppressiva, har forhøjet risiko for bakterielle, virale og svampeinfektioner (hvoraf nogle kan forårsage dødelige tilstande), inklusiv dem, der skyldes opportunistiske mikroorganismer og latent viral reaktivering.
English: • cholestyramine - used to treat high cholesterol
Danish: • colestyramin - bruges til behandling af forhøjet kolesterol
English: CellCept has a moderate influence on the ability to drive and use machines.
Danish: CellCept påvirker i moderat grad evnen til at føre motorkøretøj eller betjene maskiner.
English: 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)
Danish: Der skal derfor udvises forsigtighed hvis CellCept 1 g/5 ml pulver til oral suspension gives til patienter med phenylketonuri (se pkt.
English: Male patients of reproductive potential should be made aware of and discuss with a qualified health-care professional the potential risks of fathering a child.
Danish: Kvalificeret sundhedspersonale bør gøre mandlige patienter med reproduktivt potentiale opmærksomme på og tale med dem om de potentielle risici ved at blive far til et barn.
English: Tap the bottom of the closed bottle several times to loosen the powder.
Danish: Bank let nogle gange på bunden af den lukkede flaske for at løsne pulveret.
English: Contraception in women taking CellCept
Danish: Prævention hos kvinder, som tager CellCept
English: • Cellcept is provided in a 20 mL type I clear glass vial with a grey butyl rubber stopper and aluminium seal with a plastic flip-off cap.
Danish: • CellCept findes i et 20 ml klart hætteglas (type I glas) med grå butylgummiprop og aluminiumssegl med aftageligt plastiklåg.
English: This needs mixing with glucose before using.
Danish: Pulveret skal blandes med glucoseinfusionsvæske før anvendelse.
English: • Reconstituted suspension: do not store above 30°C.
Danish: • Rekonstitueret suspension: Må ikke opbevares ved temperaturer over 30 °C.
English: Background information on mycophenolate mofetil teratogenicity and mutagenicity in humans.
Danish: • Baggrundsinformation om mycophenolatmofetils teratogenicitet og mutagenicitet hos mennesker.
English: If you are a woman who could become pregnant you must use an effective method of contraception with CellCept.
Danish: Hvis du er kvinde og kan blive gravid, skal du bruge en effektiv præventionsmetode, mens du tager CellCept, herunder:
English: LIST OF EXCIPIENTS Also contains polysorbate 80, citric acid, hydrochloric acid and sodium chloride.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder også polysorbat 80, citronsyre, saltsyre og natriumchlorid.
English: Such infections include latent viral reactivation, such as hepatitis B or hepatitis C reactivation and infections caused by polyomaviruses (BK virus associated nephropathy, JC virus associated progressive multifocal leukoencephalopathy PML) .
Danish: Sådanne infektioner inkluderer latent viral reaktivering, såsom hepatitis B- eller hepatitis Creaktivering og infektioner forårsaget af polyomavira (BK-virus associeret med nefropati, JC-virus associeret med progressiv multifokal leukoencefalopati PML).
English: c.
Danish: A.
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leukoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including CellCept.
Danish: Tilfælde af BK-virus associeret med nefropati såvel som tilfælde af JC-virus associeret med progressiv multifokal leukoencefalopati (PML) er blevet rapporteret hos patienter, der behandles med immunsuppressiva herunder CellCept.
English: CellCept contains mycophenolate mofetil.
Danish: CellCept indeholder mycophenolatmofetil.
English: Due to the large differences observed in the frequency of certain ADRs across the different transplant indications, the frequency is presented separately for renal and hepatic transplant patients.
Danish: Da der er observeret store forskelle i hyppigheden af nogle bivirkninger på tværs af de forskellige transplantat-indikationer, er hyppighederne angivet separat for nyre- og levertransplanterede patienter.
English: Contents of the pack and other information Making-up the medicine
Danish: Pakningsstørrelser og yderligere oplysninger Opblanding af medicinen
English: Gently shake the vial to dissolve the medicinal product yielding a slightly yellow solution.
Danish: b) Ryst hætteglasset forsigtigt for at opløse lægemidlet til en let gul opløsning.
English: This includes medicines obtained without a prescription, such as herbal medicines.
Danish: Dette gælder også medicin, som ikke er købt på recept f.eks. naturlægemidler og vitaminer og mineraler.
English: This will make sure that the bottle adapter and child safety bottle cap are in the right position.
Danish: • Dette sikrer, at flaskeadaptoren og låget sidder i den rigtige position.
English: You must not donate blood during treatment with CellCept and for at least 6 weeks after stopping treatment.
Danish: Du må ikke give blod under behandling med CellCept og i mindst 6 uger efter behandlingens ophør.
English: Paediatric population aged 2 to 18 years The recommended dose of CellCept 1 g/5 ml powder for oral suspension is 600 mg/m2 administered twice daily (up to a maximum of 2 g/10 mL oral suspension daily).
Danish: Pædiatrisk population 2-18 år Den anbefalede dosis af CellCept 1 g/5 ml pulver til oral suspension er 600 mg/m2 administreret to gange daglig (højst 2 g/10 ml oral suspension daglig).
English: Hepatic transplant (n = 277)
Danish: Levertransplantat (n = 277)
English: Keep the blister in the outer carton in order to protect from light.
Danish: Opbevar blisterkortene i den ydre karton for at beskytte mod lys.
English: No substantial alteration of MPA pharmacokinetics is anticipated and CellCept dose adjustment is not required.
Danish: Der forudses ingen væsentlig ændring af MPAs farmakokinetik og dosisjustering af CellCept er ikke nødvendig.
English: Name and address of the manufacturer(s) responsible for batch release CellCept 250 mg capsules CellCept 500 mg film-coated tablets Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Germany.
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse - CellCept 250 mg kapsler - CellCept 500 mg filmovertrukne tabletter Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach-Wyhlen, Tyskland.
English: • CellCept should not be given to patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or to any of the excipients listed in section 6.1.
Danish: • CellCept må ikke anvendes til patienter med overfølsomhed over for mycophenolatmofetil, mycophenolsyre eller et eller flere af hjælpestofferne anført i pkt.
English: It is recommended that the second test should be performed 8 - 10 days after the first test. For transplants from deceased donors, if it is not possible to perform two tests 8-10 days apart before treatment starts (because of the timing of transplant organ availability), a pregnancy test must be performed immediately before starting treatment and a further test performed 8-10 days later.
Danish: Ved modtagelse af transplantater fra afdøde donorer, kan det på grund af tidspunktet for tilgængeligheden af transplantationsorganet, ikke altid være muligt at udføre to tests 8-10 dage efter hinanden, inden behandlingen initieres.
English: Men must not donate semen during treatment with CellCept and for at least 90 days after stopping treatment.
Danish: Mænd må ikke være sæddonorer under behandling med CellCept og i mindst 90 dage efter behandlingens ophør.
English: Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells.
Danish: Da T- og B-lymfocytter i deres proliferation, i modsætning til andre celletyper, der kan anvende alternative veje, er helt afhængige af en de novo-syntese af puriner, har MPA en mere potent cytostatisk virkning på lymfocytter end på andre celler.
English: Diarrhoea, leucopenia, sepsis and vomiting were among the most common and/or serious adverse drugs reactions associated with the administration of CellCept in combination with ciclosporin and corticosteroids.
Danish: Diarré, leukopeni, sepsis og opkastning var blandt de mest almindelige og/eller alvorlige bivirkninger i forbindelse med administration af CellCept i kombination med ciclosporin og kortikosteroider.
English: It is recommended to monitor MPA exposure levels and to adjust CellCept doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Danish: For at opretholde den kliniske effekt bør MPAeksponeringen overvåges, og CellCept-doserne justeres i forhold til dette, når rifampicin administreres samtidigt.
English: Therefore, CellCept is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection.
Danish: Derfor er CellCept kontraindiceret under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet.
English: Add approximately half of the total amount of purified water to the bottle and shake the closed bottle well for about 1 minute.
Danish: Hæld ca. halvdelen af det rensede vand i flasken, og ryst den lukkede flaske i ca. 1 min.
English: Ecchymosis
Danish: Ecchymose
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF IKKE ANVENDT LÆGEMIDDEK SAMT AFFALD HERAF
English: If you forget to take CellCept
Danish: Hvis du har glemt at tage CellCept
English: Ciclosporin A (CsA) pharmacokinetics are unaffected by mycophenolate mofetil.
Danish: Ciclosporins (CsA) farmakokinetik påvirkes ikke af mycophenolatmofetil.
English: Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed).
Danish: Medfødte misdannelser, som har været rapporteret, inkluderer abnormiteter i ører, øjne og ansigt (læbe-gane spalte) eller i fingrenes udvikling, samt i hjerte, spiserør, nyrer og nervesystem (f.eks. manglende sammenvoksning af ryggraden (spina bifida)).
English: • Based on literature reports, malformations occurred in 23 to 27% of live births in women exposed to mycophenolate mofetil during pregnancy (compared to 2 to 3 % of live births in the overall population and approximately 4 to 5% of live births in solid organ transplant recipients treated with immunosuppressants other than mycophenolate mofetil).
Danish: • Baseret på litteraturrapporter forekom misdannelser hos 23 til 27% af levendefødte børn, hvor moderen var eksponeret for mycophenolatmofetil under graviditet (sammenlignet med 2 til 3% hos levendefødte børn i hele populationen og ca. 4 til 5% hos patienter, der havde gennemgået en transplantation af solide organer, og som blev behandlet med andre immunsuppressiva end mycophenolatmofetil).
English: In patients with renal impairment in whom 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.
Danish: 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.
English: Hypersensitivity reactions to CellCept have been observed (see section 4.8).
Danish: 6.1 Der er observeret overfølsomhedsreaktioner over for CellCept (se pkt.
English: If you stop taking CellCept
Danish: Hvis du holder op med at tage CellCept
English: Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18 years) given 600 mg/m2 mycophenolate mofetil orally twice daily.
Danish: Farmakokinetiske parametre evalueredes hos 49 nyretransplanterede børn (2-18 år), som fik 600 mg/m2 mycophenolatmofetil oralt to gange daglig.
English: 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
Danish: CellCept 1 g/5 ml pulver til oral suspension sorbitol silica, kolloid, vandfri natriumcitrat sojabønnelecithin blandet frugtsmag xanthangummi aspartam* (E951) methylparahydroxybenzoat (E218) citronsyre, vandfri
English: Mouth, esophageal, gastric, duodenal, and intestinal ulcers often complicated by hemorrhage, as well as hematemesis, melena, and hemorrhagic forms of gastritis and colitis were commonly reported during the pivotal clinical trials.
Danish: Sår i munden, spiserøret, mavesækken, duodenum og tarmene, ofte forværret af blødninger, såvel som hæmatemese, melæna og hæmoragisk gastritis og colitis blev indberettet som almindelige bivirkninger i de pivotale kliniske studier.
English: In contrast, if concomitant CsA treatment is stopped, an increase in MPA AUC of around 30% should be expected.
Danish: Derimod må en stigning i MPAs AUC på ca. 30 % forventes, hvis samtidig CsA-behandling seponeres.
English: • If you are breast-feeding.
Danish: • hvis du ammer.
English: even if their symptoms are the same as yours
Danish: Det kan være skadeligt for andre, selv om de har de samme symptomer, som du har.
English: Due to the large differences observed in the frequency of certain ADRs across the different transplant indications, the frequency is presented separately for renal, hepatic and cardiac transplant patients.
Danish: Da der er observeret store forskelle i hyppigheden af nogle bivirkninger på tværs af de forskellige transplantat-indikationer, er hyppighederne angivet separat for nyre-, lever- og hjertetransplanterede patienter.
English: METHOD OF ADMINISTRATION Oral use
Danish: ADMINISTRATIONSMETODE Oral anvendelse
English: Psychiatric disorders Confusional state
Danish: Psykiske forstyrrelser Konfusion
English: This means that to prepare a 1 g dose of mycophenolate mofetil the content of 2 reconstituted vials (approx. 2 x 15 mL) must be further diluted into 140 mL glucose intravenous infusion 5% solution.
Danish: Det betyder, at for at fremstille en dosis på 1 g mycophenolatmofetil skal indholdet af to rekonstituerede hætteglas (ca. 2 x 15 ml) fortyndes yderligere med 140 ml 5 % glucoseinfusionsvæske.
English: Before you start taking CellCept
Danish: • Før du starter med at tage CellCept
English: CellCept 250 mg capsules:
Danish: CellCept 250 mg kapsler:
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept (see section
Danish: Tilfælde af pure red cell aplasia (PRCA) er rapporteret hos patienter, behandlet med CellCept (se pkt
English: It is recommended that CellCept 1 g/5 ml powder for oral suspension be reconstituted by the pharmacist prior to dispensing to the patient.
Danish: Det anbefales at rekonstituere CellCept 1 g/5 ml pulver til oral suspension på apoteket før den udleveres til patienten.
English: The most common gastrointestinal disorders, however, were diarrhea, nausea and vomiting.
Danish: De mest almindelige bivirkninger i fordøjelsessystemet var diarré, kvalme og opkastning.
English: Contraception in men taking CellCept
Danish: Prævention hos mænd, som tager Cellcept
English: 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.
Danish: Middelværdien af MPAG-AUC efter en enkelt dosis var 3-6 gange højere hos personer med svært nedsat nyrefunktion end hos personer med let nedsat nyrefunktion eller normale, sunde personer svarende til den kendte renale udskillelse af MPAG.
English: The final concentration of the solution is 6 mg/mL mycophenolate mofetil.
Danish: Den endelige koncentration af opløsningen er 6 mg mycophenolatmofetil per ml.
English: If you take more CellCept than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du tager mere CellCept, end du har fået besked på, skal du straks tale med en læge eller tage på sygehuset.
English: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with CellCept in combination with other immunosuppressants.
Danish: Tilfælde af pure red cell aplasia (PRCA) er blevet rapporteret hos patienter i behandling med CellCept i kombination med andre immunsuppressiva.
English: No data are available for treatment of first or refractory rejection in paediatric transplant patients.
Danish: Der er ingen data vedrørende behandling af førstegangs- eller recidiverende afstødning hos pædiatriske transplanterede patienter.
English: CellCept 500 mg powder for concentrate for solution for infusion does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.
Danish: CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, indeholder ikke konserveringsmiddel; derfor skal rekonstitution og fortynding af produktet foretages under aseptiske forhold.
English: • antacids or proton pump inhibitors - used for acid problems in your stomach such as indigestion
Danish: • syreneutraliserende midler eller protonpumpehæmmere - bruges mod for meget mavesyre, f.eks. ved fordøjelsesbesvær
English: Add the remainder of water and shake the closed bottle well for about 1 minute.
Danish: Hæld resten af vandet i og ryst den aflukkede flaske i ca. 1 min.
English: Advice on action if a pregnancy occurs or is suspected during or shortly after being treated with mycophenolate mofetil.
Danish: • Vejledning i, hvilke tiltag der skal igangsættes, hvis graviditet indtræder, eller hvis der er en mistanke om, at graviditet er indtrådt under behandling med mycophenolatmofetil eller kort tid efter behandlingen.
English: Take care not to let any powder from inside a broken capsule get into your eyes or mouth.
Danish: Undgå pulver fra itugåede kapsler kommer i kontakt med dine øjne eller mund.
English: INFORMATION IN BRAILLE cellcept 500 mg
Danish: INFORMATION I BRAILLESKRIFT cellcept 500 mg
English: There have been reports of aplastic anaemia and bone marrow failure in patients treated with CellCept, some of which have been fatal.
Danish: Der har været indberetninger om aplastisk anæmi og knoglemarvssvigt hos patienter behandlet med CellCept, hvor nogle har været dødelige.
English: The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by coadministration of CellCept (see also section 5.2).
Danish: Farmakokinetikken og farmakodynamikken af orale antikonceptionsmidler påvirkedes ikke af samtidig administration af CellCept (se også pkt.
English: Gastrointestinal disorders Abdominal distension
Danish: Mave-tarmkanalen Abdominal distension
English: Then shake the closed bottle well for about 1 minute.
Danish: • Ryst derefter den lukkede flaske godt i ca. 1 minut.
English: Vascular disorders Hypertension
Danish: Vaskulære sygdomme Hypertension
English: IV CellCept should be administered for the first 4 days following hepatic transplant, with oral CellCept initiated as soon after this as it can be tolerated.
Danish: CellCept skal gives intravenøst i de 4 første dage efter en levertransplantation og herefter skal oral administration påbegyndes så snart det tåles.
English: Oral CellCept should be initiated within 5 days following transplantation.
Danish: Oralt CellCept bør gives inden for 5 døgn efter transplantationen.
English: Cardiac transplant n = 289
Danish: Hjertetransplantat (n = 289)
English: Diarrhea
Danish: Diarré
English: Viral infections
Danish: Virale infektioner
English: OTHER SPECIAL WARNING(S), IF NECESSARY Avoid skin contact with infusion solution
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Undgå at infusionsopløsningen kommer i kontakt med huden
English: 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.
Danish: CellCept er, i kombination med ciclosporin og kortikosteroider, indiceret til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre-, hjerte- eller levertransplantater.
English: PHARMACEUTICAL FORM AND CONTENTS 50 Tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 50 tabletter
English: • The other ingredients are sorbitol, colloidal anhydrous silica, sodium citrate, soybean lecithin, mixed fruit flavour, xanthan gum, aspartame* (E951), methyl parahydroxybenzoate (E218), citric acid anhydrous.
Danish: • Øvrige indholdsstoffer: Sorbitol, silica, kolloid, vandfri, natriumcitrat, sojabønne lecitin, blandet frugtsmag, xanthangummi, aspartam* (E951), methylparahydroxybenzoat (E218), citronsyre, vandfri.
English: An increase of MPA AUC0-∞ by 35% was observed with concomitant administration of isavuconazole.
Danish: Isavuconazol Ved samtidig administration af isavuconazol blev der observeret en stigning i MPA AUC0-∞ med 35%.
English: Then, tightly close the bottle with child safety bottle cap.
Danish: Luk derefter flasken tæt med det børnesikrede låg.
English: Endoscopic investigation of patients with CellCept-related diarrhea have revealed isolated cases of intestinal villous atrophy (see section 4.4).
Danish: Endoskopi af patienter med CellCept-relatered diarré har identificeret isolerede tilfælde af intestinal villøs atrofi (se pkt 4.4).