FrancophonIA/ELRC3.0 huggingface dataset:
English: Note: If required, CellCept 1 g/5 ml powder for oral suspension can be administered via a nasogastric tube with a minimum size of 8 French (minimum 1.7 mm interior diameter).
Danish: Om nødvendigt kan CellCept 1 g/5 ml pulver til oral suspension gives via en næsesonde af minimum størrelse på 8 French (den indre diameter skal være mindst 1,7 mm).
English: The antibody response to other vaccines may be diminished (see also 4.4).
Danish: Antistofresponset overfor andre vacciner kan nedsættes (se også pkt.
English: Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have been observed in patients treated with CellCept.
Danish: Isolerede tilfælde af abnorm neutrofil morfologi, inklusive den erhvervede Pelger-Huet anomali, er observeret hos patienter, som er behandlet med CellCept.
English: During your entire treatment with CellCept
Danish: • Under hele behandlingen med CellCept
English: As can happen in patients taking this type of medicine (immune-suppressants), a very small number of CellCept patients have developed cancer of the lymphoid tissues and skin.
Danish: Som det kan forekomme hos patienter, der tager denne type medicin (immunsuppressiva), har et meget lille antal CellCept-patienter udviklet kræft i lymfevæv og hud.
English: Caution should be used with medicinal products that interfere with enterohepatic recirculation because of their potential to reduce the efficacy of CellCept.
Danish: Der skal udvises forsigtighed med lægemidler, som interfererer med den enterohepatiske recirkulation pga. risikoen for nedsat effekt af CellCept.
English: Patients on CellCept who develop recurrent infections should have their serum immunoglobulins measured.
Danish: Patienter i behandling med CellCept, der får tilbagevendende infektioner, skal have målt serumimmunoglobuliner.
English: Tap the closed bottle several times to loosen the powder.
Danish: Knips flere gange på den aflukkede flaske for at løsne pulveret.
English: Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, CellCept is contraindicated in nursing mothers (see section 4.3).
Danish: På grund af risikoen for alvorlige bivirkninger af mycophenolatmofetil hos ammende spædbørn, er CellCept kontraindiceret hos ammende mødre (se pkt.
English: The parent substance mycophenolate mofetil can be measured systemically during intravenous infusion.
Danish: Moderstoffet mycophenolatmofetil kan måles systemisk under intravenøs infusion.
English: Taking food and drink has no effect on your treatment with CellCept.
Danish: Brug af CellCept sammen med mad og drikke Indtagelse af mad og drikke har ingen virkning på din behandling med CellCept.
English: Very Common Very Common General disorders and administration site conditions Asthenia
Danish: Meget almindelig Meget almindelig Almene symptomer og reaktioner på administrations-stedet Asteni
English: Pregnancy, puerperium and perinatal conditions Cases of spontaneous abortions have been reported in patients exposed to mycophenolate mofetil, mainly in the first trimester, see section 4.6.
Danish: Graviditet, puerperium og den perinatale periode Der er rapporteret tilfælde af spontane aborter hos patienter, som har været eksponeret for mycophenolatmofetil, hovedsagelig i første trimester (se pkt.
English: Spontaneous abortion (rate of 45% to 49%) and congenital malformations (estimated rate of 23% to 27%) have been reported following MMF exposure during pregnancy.
Danish: Spontane aborter (frekvens på 45% til 49%) og medfødte misdannelser (estimeret frekvens på 23% til 27%) er blevet rapporteret efter mycophenolatmofetil eksponering under graviditet.
English: The first dose is given to you as soon as possible after the transplant operation.
Danish: • Den første dosis gives så hurtigt som muligt efter transplantationen.
English: Do not use cloths or wipes for drying.
Danish: Brug ikke klude eller vådservietter til tørring.
English: • isavuconazole - used to treat fungal infections
Danish: • isavuconazol - bruges til behandling af svampeinfektioner
English: Patients taking CellCept should have complete blood counts weekly during the first month, twice monthly for the second and third months of treatment, then monthly through the first year.
Danish: Patienter, som får CellCept, skal have foretaget fuldstændig blodtælling ugentligt i den første måned, to gange månedligt i anden og tredje behandlingsmåned og derefter månedligt i det første år.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Caution should be used during concomitant administration because of the potential to reduce efficacy of CellCept.
Danish: Der skal udvises forsigtighed ved samtidig administration pga. risikoen for nedsat effekt af CellCept.
English: • If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients in this medicine (listed in Section 6)
Danish: • hvis du er allergisk over for mycophenolatmofetil, mycophenolsyre eller et af de øvrige indholdsstoffer i lægemidlet (angivet i punkt 6)
English: As a precaution you or your female partner are recommended to use reliable contraception during treatment and for 90 days after you stop taking CellCept.
Danish: Som en sikkerhedsforanstaltning anbefales det at du eller din kvindelige partner bruger pålidelig prævention under behandlingen og i 90 dage efter, at du er stoppet med at tage CellCept.
English: In hepatic transplant patients initiated on CellCept and tacrolimus, the AUC and Cmax of MPA, the active metabolite of CellCept, were not significantly affected by co-administration with tacrolimus.
Danish: Hos levertransplanterede patienter, der indledningsvis blev behandlet med CellCept og tacrolimus samtidigt, blev MPAs Cmax og AUC - CellCepts aktive metabolit - ikke signifikant påvirket af den samtidige administration af tacrolimus.
English: It is available in packs of 4 vials.
Danish: • Det findes i pakninger med 4 hætteglas
English: 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).
Danish: Efter rekonstitution til en koncentration på 6 mg/ml skal CellCept 500 mg pulver til infusionsvæske gives som langsom intravenøs infusion over en periode på 2 timer via en perifer eller central vene (se pkt.
English: Shake bottle well before use
Danish: Flasken skal rystes godt før brugen
English: The educational materials will reinforce the warnings about the teratogenicity of mycophenolate, provide advice on contraception before therapy is started and guidance on the need for pregnancy testing.
Danish: Uddannelsesmaterialet vil fremhæve advarsler vedrørende mycophenolats teratogenicitet, give vejledning om antikonception inden behandling initieres og vejledning omkring nødvendigheden af graviditetstests.
English: In addition, a pregnancy follow-up questionnaire including details of exposure during pregnancy, including timing and dose; duration of therapy, before and during pregnancy; concomitant drugs; known teratogenic risks and full details of congenital malformations should be agreed to with the national competent authorities.
Danish: Spørgeskemaet skal indeholde fyldestgørende oplysninger om eksponering under graviditet, herunder tidsangivelse og dosis; behandlingsvarighed før og under graviditet; lægemidler, som har været anvendt samtidig; kendte teratogene risici og fyldestgørende oplysninger om medfødte misdannelser.
English: Take 5 mL suspension in the morning and then 5 mL suspension in the evening.
Danish: • Tag 5 ml suspension om morgenen og 5 ml suspension om aftenen.
English: Caution should be exercised when switching combination therapy from regimens containing immunosuppressants, which interfere with MPA enterohepatic recirculation, e.g. ciclosporin, to others devoid of this effect, e.g. tacrolimus, sirolimus, belatacept, or vice versa, as this might result in changes of MPA exposure.
Danish: Der skal udvises forsigtighed ved skift fra kombinationsbehandling indeholdende immunsupressiva som interfererer med MPAs enterohepatiske kredsløb, f.eks. ciclosporin, til andre som ikke interfererer, f.eks tacrolimus, sirolimus, belatacept, eller omvendt, da dette kan ændre eksponeringen af MPA.
English: 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).
Danish: Patienterne skal underrettes om, at under behandling med CellCept kan vaccinationer være mindre effektive, og levende svækkede vacciner bør undgås (se pkt.
English: 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).
Danish: Den ikke-kliniske toksikologiske profil af mycophenolatmofetil forekommer i overenstemmelse med bivirkninger observerede i de humane kliniske studier som nu fremviser bivirkningsdata, der er mere relevante for en patientpopulation (se 4.8).
English: Lung problems such as:
Danish: Lungelidelser såsom:
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 30 °C
English: Inspect the resulting solution for particulate matter and discoloration prior to further dilution.
Danish: c) Inspicer opløsningen for partikler og misfarvning før yderligere fortynding.
English: If you think that you have had too much medicine, talk to your doctor or nurse straight away.
Danish: Hvis du tror, at du har fået for meget medicin, skal du tale med lægen eller sundhedspersonalet med det samme.
English: Dose adjustment of CellCept does not appear to be necessary.
Danish: Justering af CellCept-dosis er ikke nødvendig.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CellCept film-coated tablets should be handled with care Do not crush the tablets
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER CellCept filmovertrukne tabletter skal håndteres forsigtigt Tabletterne må ikke knuses
English: 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.
Danish: To genotoksicitetstests (in vitro muselymfom test og in vivo museknoglemarvs-mikronucleus-test) viste, at mycophenolatmofetil potentielt kan forårsage kromosomaberrationer.
English: Pregnancy tests should be repeated as clinically required (e.g. after any gap in contraception is reported).
Danish: En ny graviditetstest skal udføres som klinisk indiceret (f.eks. efter rapportering af manglende antikonception).
English: (The shelf-life of the reconstituted suspension is two months.)
Danish: (Holdbarheden af den rekonstituerede suspension er 2 måneder).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral administration after constitution
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til oral anvendelse efter rekonstitution
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: • Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of CellCept (1.5 g BID) were administered to hepatic transplant patients taking tacrolimus.
Danish: I modsætning hertil blev AUC for tacrolimus øget med ca. 20 %, når flere CellCept-doser (1,5 g to gange daglig) blev givet til levertransplanterede patienter, som fik tacrolimus.
English: Of these, 991 were included in the three renal studies and 277 were included in one hepatic study.
Danish: Af disse deltog 991 i tre nyrestudier og 277 deltog i et leverstudie.
English: Azathioprine was the comparator used in the hepatic study and in two of the renal studies whilst the other renal study was placebo-controlled.
Danish: Azathioprin var komparator i leverstudiet og i to af nyrestudierne, hvorimod det sidste nyrestudie var placebokontrolleret.
English: Cytopenias, including leucopenia, anemia, thrombocytopenia and pancytopenia, are known risks associated with mycophenolate mofetil and may lead or contribute to the occurrence of infections and hemorrhages (see section 4.4).
Danish: Cytopenier, inklusiv leukopeni, anæmi, trombocytopeni og pancytopeni er velkendte risici associeret med mycophenolatmofetil og kan forårsage eller medvirke til infektioner og blødninger (se pkt.
English: They have “CellCept 250” printed in black on the capsule cap and “Roche” printed in black on the capsule body.
Danish: ”CellCept 250” er printet i sort på kapselhovedet, og ”Roche” er printet i sort på kapselkroppen.
English: Of these, 991 were included in the three renal studies, 277 were included in one hepatic study, and 289 were included in one cardiac study.
Danish: Af disse deltog 991 i tre nyrestudier, 277 deltog i et leverstudie og 289 deltog i et hjertestudie.
English: If this happens, rinse your eyes with plain water.
Danish: • Hvis dette sker, skal du skylle øjnene med vand.
English: • Take 7.5 mL suspension in the morning and then 7.5 mL suspension in the evening.
Danish: • Tag 7,5 ml suspension om morgenen og 7,5 ml suspension om aftenen.
English: Adverse reactions attributable to peripheral venous infusion were phlebitis and thrombosis, both observed at 4% in patients treated with CellCept 500 mg powder for concentrate for solution for infusion.
Danish: Bivirkninger som kunne tilskrives den perifere intravenøse infusion var flebitis og tromboser som begge blev observeret hos 4 % af de patienter, som blev behandlet med CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning.
English: The types of adverse reactions reported during post-marketing with CellCept are similar to those seen in the controlled renal, cardiac and hepatic transplant studies.
Danish: Typen af bivirkninger rapporteret efter markedsføring er sammenlignelig med de der ses i de kontrollerede nyre-, hjerte- og levertransplantantionsstudier.
English: Do not stop taking CellCept unless your doctor tells you to.
Danish: Stop ikke med at tage CellCept, medmindre lægen har bedt dig om det.
English: The risk increases with total immunosuppressive load (see section 4.4).
Danish: Risikoen øges med stigende immunsuppressiv belastning (se pkt.
English: Gastrointestinal hemorrhage
Danish: Gastrointestinal blødning
English: Oral administration of 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.
Danish: Oral administration af 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.
English: The pharmacokinetics of mycophenolate mofetil and its metabolites have not been found to be altered in the elderly patients (≥ 65 years) when compared to younger patients.
Danish: Farmakokinetikken af mycophenolatmofetil og dets metabolitter er ikke observeret at være anderledes hos ældre patienter (≥ 65 år) sammenlignet med yngre patienter.
English: Oral CellCept 1 g/5 ml powder for oral suspension should be initiated within 72 hours following transplantation.
Danish: Oral dosis af CellCept 1 g/5 ml pulver til oral suspension bør gives inden for 72 timer efter transplantationen.
English: If you have ever had a problem with your digestive system such as a stomach ulcer If you have a rare problem with your metabolism called “phenylketonuria” which runs in families
Danish: • hvis du har et sjældent problem med din metabolisme kaldet ”phenylketonuri”, som løber i familien
English: If this happens, rinse with plenty of plain water.
Danish: • Hvis dette sker, skal du skylle med rigeligt vand.
English: CellCept tablets: lavender coloured caplet-shaped tablet, engraved with "CellCept 500" on one side and "ROCHE" name on the other.
Danish: CellCept tabletter: lille kappeformet, lavendelfarvet tablet, med "CellCept 500" præget på den ene side og "Roche" på den anden.
English: This will assure the proper seating of the bottle adapter in the bottle and child-resistant status of the cap.
Danish: Derved sikres at adapteren sidder rigtigt i flasken og bevarer lågets børnesikring.
English: Aplasia pure red cell
Danish: Pure red cell aplasia (PRCA)
English: Renal transplant (n = 991)
Danish: Nyretransplantat (n = 991)
English: Antibiotics eliminating β-glucuronidase-producing bacteria in the intestine (e.g. aminoglycoside, cephalosporin, fluoroquinolone, and penicillin classes of antibiotics) may interfere with MPAG/MPA enterohepatic recirculation thus leading to reduced systemic MPA exposure.
Danish: Antibiotika, der eliminerer β-glukuronidaseproducerende bakterier i tarmen (f.eks. aminoglycosid, cephalosporin, fluorquinolon og penicillinklasser af antibiotika) kan interferere med MPAG/MPA enterohepatisk recirkulation, hvilket fører til reduceret systemisk MPA-eksponering.
English: • Spontaneous abortions have been reported in 45 to 49% of pregnant women exposed to mycophenolate mofetil, compared to a reported rate of between 12 and 33% in solid organ transplant patients treated with immunosuppressants other than mycophenolate mofetil.
Danish: • Spontante aborter er rapporteret hos 45 til 49 % af de gravide kvinder, som var eksponeret for mycophenolatmofetil, sammenlignet med en hyppighed på 12 til 33 % hos patienter, der havde gennemgået en transplantation af solide organer, og som blev behandlet med andre immunsuppressiva end mycophenolatmofetil.
English: Take 3 tablets in the morning and then 3 tablets in the evening.
Danish: • Tag 3 tabletter om morgenen og derefter 3 tabletter om aftenen.
English: (MedDRA)
Danish: (mellemøret);
English: Table 1 Summary of adverse drug reactions occurring in patients treated with CellCept reported from clinical trials and post marketing experience
Danish: Tabel 1: Skema over indberettede bivirkninger hos patienter behandlet med CellCept i kliniske studier og efter markedsføring
English: • CellCept capsules are oblong shaped with one end blue and the other end brown.
Danish: • CellCept kapsler er aflange og blå i den ene ende og brun i den anden.
English: Take 2 tablets in the morning and then 2 tablets in the evening.
Danish: • Tag 2 tabletter om morgenen og 2 tabletter om aftenen.
English: CellCept capsules: oblong, blue/brown, branded with black "CellCept 250" on the capsule cap and "Roche" name on the capsule body.
Danish: CellCept kapsler: aflang, blå/brun, mærket med "CellCept 250" i sort på kapslens "hoved" og "Roche" på kapslens "krop".
English: The pharmacokinetics of mycophenolate mofetil and its metabolites have not been found to be altered in the elderly patients (≥ 65 years) when compared to younger transplant patients.
Danish: Farmakokinetikken af mycophenolatmofetil og dets metabolitter er ikke observeret at være anderledes hos ældre patienter (≥ 65 år) sammenlignet med yngre transplanterede patienter.
English: Shake well before use Read the package leaflet before use
Danish: Rystes godt før brug Læs indlægssedlen inden brug
English: OTHER SPECIAL WARNING(S), IF NECESSARY Do not breathe the powder before constitution or allow it to touch your skin Avoid skin contact with the reconstituted suspension
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Pulveret må ikke indåndes før rekonstitution eller komme i berøring med huden Undgå at den rekonstituerede suspension kommer i berøring med huden
English: Do not stop having CellCept unless your doctor tells you to.
Danish: Stop ikke med at bruge CellCept, medmindre lægen har bedt dig om det.
English: Patients treated with immunosuppressants, including CellCept, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Danish: Patienter, som bliver behandlet med immunsuppressiva herunder CellCept, har en øget risiko for opportunistiske infektioner (bakteriel, svampe, viral og protozoel), dødelige infektioner og sepsis (se pkt.
English: Do not take CellCept if you are breast-feeding.
Danish: Tag ikke CellCept, hvis du ammer.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack:150 (3 packs of 50) film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 150 (3 pakker af 50) filmovertrukne tabletter
English: There is no basis for CellCept dose adjustment following cardiac transplant rejection.
Danish: Der er ikke grundlag for justering af CellCept dosis efter afstødning af hjertetransplantat.
English: Therefore, a change in the dose of CellCept should not normally be necessary in the absence of clinical evidence of graft dysfunction.
Danish: Derfor er det normalt ikke nødvendigt at ændre dosis af CellCept, hvis der ikke er klinisk evidens for dysfunktion af transplantatet.
English: Cellcept may cause somnolence, confusion, dizziness, tremor or hypotension, and therefore patients are advised to use caution when driving or using machines.
Danish: CellCept kan forårsage somnolens, konfusion, svimmelhed, tremor og hypotension, og patienterne bør derfor tilrådes forsigtighed ved bilkørsel og maskinbetjening.
English: Azathioprine was the comparator used in the hepatic and cardiac studies and in two of the renal studies whilst the other renal study was placebocontrolled.
Danish: Azathioprin var komparator i lever- og hjertestudierne og i to af nyrestudierne, hvorimod det sidste nyrestudie var placebokontrolleret.
English: Oral CellCept should be initiated within 72 hours following transplantation.
Danish: Oralt CellCept bør gives inden for 72 timer efter transplantationen.
English: • If you are a woman who could be pregnant and you have not provided a negative pregnancy test before your first prescription as mycophenolate causes birth defects and miscarriage.
Danish: • hvis du er kvinde og kan blive gravid, og der ikke foreligger en negativ graviditetstest, før du har fået den første recept, eftersom mycophenolat forårsager medfødte misdannelser og abort.
English: Then put the tip of the dispenser firmly into the opening of the bottle adapter.
Danish: Sæt derefter dispenserens spids fast i flaskeadaptorens åbning.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CellCept capsules should be handled with care Do not open or crush the capsules and breathe the powder inside the capsules or allow it to touch your skin
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER CellCept kapsler skal håndteres forsigtigt Kapslerne må ikke åbnes eller knuses, og pulveret i kapslerne må ikke indåndes eller komme i berøring med huden
English: 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 rekonstitution og fortynding af lægemidlet.
English: Thus, other substances known to undergo renal tubular secretion may compete with MPAG, and thereby raise plasma concentrations of MPAG or the other substance undergoing tubular secretion.
Danish: Derfor kan andre stoffer, der vides at udskilles ved renal tubulær sekretion, konkurrere med MPAG og derved forhøje plasmakoncentrationerne af MPAG eller det andet stof, der udskilles ved tubulær sekretion.
English: These include serious allergic reactions (such as anaphylaxis, angioeodema), fever, feeling very tired, difficulty sleeping, pains (such as stomach, chest, joint or muscle), headache, flu symptoms and swelling.
Danish: Disse inkluderer alvorlige allergiske reaktioner (såsom anafylaksi, angioødem), feber, træthedsfornemmelse, søvnbesvær, smerter (såsom smerter i maven, brystkassen, led eller muskler), hovedpine, influenzasymptomer og opsvulmen.
English: Blood and lymphatic system disorders Anemia
Danish: Blod og lymfesystem Anæmi