FrancophonIA/ELRC3.0 huggingface dataset:
English: In renal transplant patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2), outside the immediate post-transplant period, doses greater than 1 g administered twice a day should be avoided.
Danish: Hos nyretransplanterede patienter med svær kronisk nedsat nyrefunktion (glomerulær filtrationsrate < 25 ml/min/1,73 m2), bortset fra perioden umiddelbart efter transplantationen, skal doser på mere end 1 g administreret to gange daglig undgås.
English: PHARMACEUTICAL FORM AND CONTENTS 300 Capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 300 kapsler
English: Lymphoma
Danish: Lymfom
English: CellCept 500 mg powder for concentrate for solution for infusion solution should not be mixed or administered concurrently via the same catheter with other intravenous medicinal products or infusion admixtures.
Danish: CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, infusionsopløsning må ikke blandes eller gives samtidigt gennem det samme kateter med andre intravøse lægemidler eller infusionsblandinger.
English: In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2) were 28 - 75% higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Danish: I et enkeltdosisstudie (6 personer per gruppe) blev middelværdi for plasma MPA-AUC hos personer med svær, kronisk nedsat nyrefunktion (glomerulær filtrationsrate < 25 ml/min/1,73 m2) observeret til 28-75 % højere i forhold til middelværdierne hos normale, sunde personer eller personer med let nedsat nyrefunktion.
English: 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.
Danish: Patienter, der får CellCept, bør monitoreres for neutropeni, som kan være relateres til CellCept, samtidig medicin, virale infektioner eller en eller anden kombination af disse årsager.
English: Other problems such as: weight loss, gout, high blood sugar, bleeding, bruising.
Danish: Andre lidelser såsom: • vægttab, urinsyregigt, forhøjet blodsukker, blødning, blå mærker.
English: The corresponding frequency category for each adverse drug reaction is based on the following convention: very common
Danish: Følgende hyppighedskategorier er anvendt: meget almindelig
English: Heart and blood vessel problems such as: change in blood pressure, accelerated heartbeat, widening of blood vessels.
Danish: Lidelser i hjerte og blodkar såsom: • ændringer i blodtrykket, øget hjerterytme, udvidelse af blodkar
English: Very Common Very Common Very Common Neoplasms benign, malignant and unspecified (including cysts and polyps) Benign neoplasm of skin
Danish: Meget almindelig Meget almindelig Benigne, maligne og uspecificerede neoplasmer (inkl.
English: INFORMATION IN BRAILLE cellcept 250 mg
Danish: INFORMATION I BRAILLESKRIFT cellcept 250 mg
English: Note: 991 (2 g / 3 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.
Danish: Note: 991 (2 g / 3 g CellCept daglig), 289 (3 g CellCept daglig) og 277 (2 g intravenøs / 3 g oral CellCept daglig) patienter i fase III- studier blev behandlet med henblik på forebyggelse af afstødelse efter henholdsvis nyre-, hjerte- og levertransplantation.
English: The adverse drug reactions (ADRs) from clinical trials and post marketing experience are listed in Table 1, by MedDRA system organ class (SOC) along with their frequencies.
Danish: Bivirkninger fra de kliniske studier og efter markedsføring er angivet i tabel 1 efter MedDRAs systemorganklasse og hyppighed.
English: Talk to your doctor if you develop a persistent cough or breathlessness
Danish: Kontakt lægen, hvis du udvikler vedvarende hoste eller kortåndethed
English: CellCept 500 mg powder for concentrate for solution for infusion must be prepared in two steps: the first step is a reconstitution step with glucose intravenous infusion 5% and the second step is a dilution step with glucose intravenous infusion 5%.
Danish: CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, skal fremstilles over to trin; første trin er rekonstitution med 5 % glucose intravenøs infusionsvæske og andet trin er fortynding med 5 % glucose intravenøs infusionsvæske.
English: Take care not to let the made-up medicine get into your eyes.
Danish: Undgå at den opblandede medicin kommer i kontakt med dine øjne.
English: Precautions to be taken before handling or administering the medicinal product Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, avoid direct contact of the dry powder or prepared solutions of CellCept 500 mg powder for concentrate for solution for infusion with skin or mucous membranes.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Da mycophenolatmofetil har udvist teratogen virkning hos rotter og kaniner, skal det undgås, at hud og slimhinder kommer i direkte kontakt med tørt pulver og opløsninger af CellCept 500 mg pulver til koncentrat til infusionsvæske undgås.
English: Multipacks containing 150 (3 packs of 50) tablets
Danish: Multipakning indeholder 150 (3 pakker af 50) tabletter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON FOR BLISTER
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE DELPAKNING TIL BLISTER
English: diarrhea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.
Danish: • diarré, forstoppelse, kvalme, fordøjelsesbesvær, appetitløshed, luft i maven.
English: This data support extrapolation of this finding to all antacids because the reduction in exposure when CellCept was coadministered with magnesium and aluminium hydroxides is considerably less than when CellCept was co-administered with PPIs.
Danish: Disse data supporterer ekstrapolering af dette fund til alle antacida, fordi reduktionen i eksponering er betydelig mindre, når Cellcept gives samtidig med magnesium- og aluminumhydroxider, end når Cellcept gives samtidig med protonpumpehæmmere.
English: This leaflet was last revised on {MM/YYYY} Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Danish: Denne indlægsseddel blev senest godkendt den {MM/ÅÅÅÅ} Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: • There is no information for the use of CellCept in children with a liver transplant.
Danish: • Der er ingen information om brug af CellCept til levertransplanterede børn.
English: Musculoskeletal pain such as myalgia, and neck and back pain were also very commonly reported.
Danish: Smerter i led og muskler som myalgi, nakke- og rygsmerter blev også indberettet som meget almindelige bivirkninger.
English: PHARMACEUTICAL FORM AND CONTENTS 100 Capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 100 kapsler
English: An estimated total of 1557 patients received CellCept during five clinical trials in the prevention of acute organ rejection.
Danish: I alt 1.557 (estimeret antal) patienter blev i fem kliniske studier behandlet med CellCept med henblik på forebyggelse af akut transplantatafstødelse.
English: 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.
Danish: Disse effekter forekom ved systemiske eksponeringsniveauer som er lig med eller mindre end de kliniske niveauer ved den anbefalede dosis på 2 g daglig.
English: Note: 991 (2 g / 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 and hepatic transplantation, respectively
Danish: Note: 991 (2 g / 3 g CellCept daglig) og 277 (2 g intravenøs / 3 g oral CellCept daglig) patienter i fase III- studier blev behandlet med henblik på forebyggelse af afstødelse efter henholdsvis nyre- og levertransplantation.
English: SOLUTION MUST NOT BE ADMINISTERED BY RAPID OR BOLUS INTRAVENOUS INJECTION.
Danish: OPLØSNING MÅ IKKE GIVES SOM EN HURTIG INJEKTION ELLER SOM EN BOLUSINJEKTION.
English: Skin hypertrophy
Danish: Hud hypertrofi
English: What CellCept contains
Danish: CellCept indeholder:
English: Skin and subcutaneous tissues disorders Acne
Danish: Hud og subkutane væv Alopeci
English: EU/1/96/005/003 CellCept
Danish: EU/1/96/005/003 CellCept (300 kapsler)
English: Measure 94 mL of purified water in a measuring cylinder.
Danish: Afmål 94 ml renset vand i et målebæger.
English: CellCept tablets microcrystalline cellulose polyvidone (K-90) croscarmellose sodium magnesium stearate
Danish: CellCept tabletter mikrokrystallinsk cellulose polyvidon (K-90) croscarmellosenatrium magnesiumstearat
English: Always take CellCept exactly as your doctor has told you.
Danish: Tag altid lægemidlet nøjagtigt efter lægens anvisning.
English: CellCept 1 g/5 ml powder for oral suspension 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 1 g/5 ml pulver til oral suspension er, i kombination med ciclosporin og kortikosteroider, indiceret til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre-, hjerte- eller levertransplantater.
English: There have been published reports of bronchiectasis in adults and children who received CellCept in combination with other immunosuppressants.
Danish: Der er publicerede tilfælde af bronkiektasi hos voksne og børn, der har fået Cellcept i kombination med andre immunsuppressiva.
English: An estimated total of 1268 patients received CellCept during four clinical trials in the prevention of acute organ rejection.
Danish: Ialt 1.268 (estimeret antal) patienter blev i fire kliniske studier behandlet med CellCept med henblik på forebyggelse af akut transplantatafstødelse.
English: • Powder for oral suspension: do not store above 30°C.
Danish: • Pulver til oral suspension: Må ikke opbevares ved temperaturer over 30 °C.
English: Manufacturing Authorisation holder responsible for batch release: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Germany.
Danish: Fremstiller, ansvarlig for batchfrigivelse: Roche Pharma AG, Emil-Barell-Str. 1, 79639 Grenzach Wyhlen, Tyskland.
English: The other ingredients are: polysorbate 80, citric acid, hydrochloric acid, sodium chloride.
Danish: • Øvrige indholdsstoffer: Polysorbat 80, citronsyre, saltsyre, natriumchlorid.
English: PHARMACEUTICAL FORM AND CONTENTS 50 film-coated tablets.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 50 filmovertrukne tabletter.
English: Discard the infusion solution if particulate matter or discoloration is observed.
Danish: Infusionsopløsningen bortkastes, hvis der ses partikler eller misfarvning.
English: Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when CellCept was concomitantly administered with sevelamer without any clinical consequences (i.e. graft rejection).
Danish: Når CellCept blev administreret samtidig med sevelamer, faldt MPA-Cmax og AUC0-12 timer med henholdsvis 30 % og 25 %, dog uden at dette havde kliniske konsekvenser (f.eks. i form af transplantatafstødning).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver flaske indeholder 35 g mycophenolatmofetil i 110 g pulver til oral suspension.
English: • The first dose of oral CellCept will be given to you at least 4 days after the transplant operation and when you are able to swallow oral medicines.
Danish: • Den første dosis CellCept til indtagelse gennem munden gives til dig tidligst 4 dage efter transplantationen, og når du er i stand til at indtage medicin gennem munden.
English: • CellCept should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
Danish: • CellCept må ikke anvendes hos fertile kvinder, som ikke anvender højeffektiv prævention (se pkt.
English: CellCept capsules pregelatinised maize starch croscarmellose sodium polyvidone (K-90) magnesium stearate
Danish: CellCept kapsler pregelatineret majsstivelse croscarmellosenatrium polyvidon (K-90) magnesiumstearat
English: • If you are pregnant or planning to become pregnant or think you may be pregnant
Danish: • hvis du er gravid eller planlægger at blive gravid eller tror, at du kan være gravid
English: Renal and urinary disorders Blood creatinine increased
Danish: Nyrer og urinveje Forhøjet serumcreatinin
English: Further dilute the content of the two reconstituted vials (approx. 2 x 15 mL) into 140 mL of glucose intravenous infusion 5%.
Danish: Trin 2. a) Derefter fortyndes indholdet af de 2 rekonstiuerede hætteglas (ca. 2 x 15 ml) med 140 ml 5 % glucose intravenøs infusionsvæske.
English: The pharmacokinetics of oral contraceptives were unaffected by co-administration of CellCept (see also section 4.5).
Danish: Farmakokinetikken af orale kontraceptiva påvirkedes ikke af samtidig administration af CellCept (se også pkt.
English: • CellCept should not be given to women who are breastfeeding (see section 4.6).
Danish: • CellCept må ikke anvendes til ammende kvinder (se pkt.
English: Then shake the closed bottle well for about another minute.
Danish: • Ryst derefter den lukkede flaske godt i yderligere 1 minut.
English: • Store in the original package in order to protect from moisture.
Danish: • Opbevares i den originale yderpakning for at beskytte mod fugt.
English: Hyperglycemia
Danish: Hyperglykæmi
English: Take off the child safety bottle cap and push the bottle adapter into the neck of the bottle.
Danish: Fjern det børnesikrede låg og tryk flaskeadaptoren ned i flaskehalsen.
English: • The first dose is given within 3 days of the transplant operation.
Danish: • Den første dosis gives inden for 3 dage efter transplantationen.
English: Reconstituted solution and the diluted solution: store between 15°C and 30°C.
Danish: • Rekonstitueret opløsning og fortyndet opløsning: Opbevares ved temperaturer mellem 15 °C og
English: The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose), i.e. 5 mL oral suspension twice daily.
Danish: Den anbefalede dosis til nyretransplanterede patienter er 1 g administreret to gange daglig (døgndosis, 2 g), dvs. 5 ml oral suspension to gange daglig.
English: Do this by: wearing protective clothing which also covers your head, neck, arms and legs using a sunscreen with a high protection factor.
Danish: • iklæde dig beskyttende beklædning, som også dækker hoved, hals, arme og ben
English: The full name of your medicine is CellCept 1 g/5 ml powder for oral suspension.
Danish: Medicinens fulde navn er CellCept 1 g/5 ml pulver til oral suspension.
English: 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).
Danish: CellCept tabletter må kun ordineres til patienter med en legemsoverflade på mindst 1,5 m2, i en dosis på 1 g to gange daglig (daglig dosis: 2 g).
English: The infusion flow rate should be controlled to equate to a 2-hour period of administration.
Danish: Infusionshastigheden skal indstilles til ca. 2 timer.
English: In patients with delayed renal graft function post-transplant, mean MPA AUC0-12h was comparable to that seen in post-transplant patients without delayed graft function.
Danish: Hos patienter med forsinket renal transplantatfunktion post-transplantativt var middelværdi for MPAAUC0-12 timer sammenlignelig med, hvad man så hos posttransplanterede patienter uden forsinket transplantatfunktion.
English: • CellCept treatment should not be initiated in women of childbearing potential without providing a pregnancy test result to rule out unintended use in pregnancy (see section 4.6).
Danish: • CellCept-behandling må ikke initieres hos fertile kvinder uden at en negativ graviditetstest foreligger, for at udelukke en uønsket anvendelse under graviditet (se pkt.
English: 1 carton contains 100 capsules (in blister packs of 10) 1 carton contains 300 capsules (in blister packs of 10)
Danish: 1 pakning indeholder 100 kapsler (blisterkort med 10 kapsler).
English: The full name of your medicine is CellCept 250 mg capsules.
Danish: Medicinens fulde navn er CellCept 250 mg kapsler.
English: Tablet coating hydroxypropyl methylcellulose hydroxypropyl cellulose titanium dioxide (E171) polyethylene glycol 400 indigo carmine aluminium lake (E132) red iron oxide (E172)
Danish: Tablet-overtrækket hydroxypropylmethylcellulose hydroxypropylcellulose titandioxid (E171) polyethylenglycol 400 indigotin aluminiumlak (E132) rød jernoxid (E172)
English: Congenital malformations, including reports of multiple malformations, have been observed postmarketing in children of patients exposed to CellCept during pregnancy in combination with other immunosuppressants.
Danish: Efter markedsføring er der observeret medfødte misdannelser, herunder rapporter om multiple misdannelser hos børn af patienter, som under graviditeten var blevet behandlet med CellCept i kombination med andre immunsuppressiva.
English: • CellCept should not be used during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6).
Danish: • CellCept må ikke anvendes under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet (se pkt.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency 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: The systemic exposure at this dose represents 2 - 3 times the clinical exposure at the recommended clinical dose of 2 g/day.
Danish: Den systemiske eksponering af denne dosis repræsenterer 2 - 3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 2 g daglig.
English: Hypercholesterolemia
Danish: Hyperkolesterolæmi
English: 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.
Danish: 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.
English: Any unused product or waste material should be disposed of in accordance with local requirements
Danish: Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer
English: Respiratory, thoracic and mediastinal disorders Bronchiectasis
Danish: Luftveje, thorax og mediastinum Bronkiektasi
English: Convulsion
Danish: Konvulsion
English: 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 (see section 4.6).
Danish: Den systemiske eksponering på disse niveauer er omtrent lig med eller mindre end 0,5 gange den kliniske eksponering ved den anbefalede dosis på 2 g daglig (se pkt.
English: • Take 4 capsules in the morning and then 4 capsules in the evening.
Danish: • Tag 4 kapsler om morgenen og 4 kapsler om aftenen.
English: The first dose is given within 24 hours of the transplant operation.
Danish: • Den første dosis gives inden for 24 timer efter transplantationen.
English: CellCept has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation.
Danish: CellCept er blevet sat i forbindelse med en øget incidens af bivirkninger i fordøjelsessystemet, inklusive sjældne tilfælde af ulceration, blødning og perforation.
English: Other medicines and CellCept
Danish: Brug af anden medicin sammen med CellCept
English: CellCept IV solution should never be administered by rapid or bolus intravenous injection.
Danish: infusionsvæske må aldrig gives som en hurtig injektion eller som en bolusinjektion.
English: General disorders and administration site conditions Edema, including peripheral, face and scrotal edema, was reported very commonly during the pivotal trials.
Danish: Almene symptomer og reaktioner på administrationsstedet Ødemer, inklusiv perifere, ansigts- og skrotalødemer, blev indberettet som meget almindelige bivirkninger i de pivotale kliniske studier.
English: Mycophenolic acid (MPA) is the active metabolite of mycophenolate mofetil. Renal transplant rejection does not lead to changes in MPA pharmacokinetics; dosage reduction or interruption of CellCept is not required.
Danish: Afstødning af nyretransplantat medfører ingen ændringer af MPAs farmakokinetik; dosisreduktion eller afbrydelse af CellCept er ikke nødvendig.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 5 ml suspension contains 1 g mycophenolate mofetil when reconstituted.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 5 ml suspension indeholder 1 g mycophenolatmofetil efter rekonstitution.
English: Paediatric population No data are available for paediatric cardiac transplant patients.
Danish: Pædiatrisk population Der er ingen data vedrørende hjertetransplantationer hos pædiatriske patienter.
English: 1 bottle contains 35 g mycophenolate mofetil in 110 g powder for oral suspension.
Danish: 1 flaske indeholder 35 g mycophenolatmofentil i 110 g pulver til oral suspension.
English: Weight decreased
Danish: Svært nedsat leverfunktion
English: Take care not to let the made-up medicine get onto your skin.
Danish: Undgå at den opblandede medicin kommer i kontakt med din hud.
English: CellCept 500 mg powder for concentrate for solution for infusion is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal or hepatic transplants.
Danish: CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, er, i kombination med ciclosporin og kortikosteroider, indiceret til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre- eller levertransplantater.
English: The recommended dose is 600 mg/ m² taken twice a day.
Danish: 600 mg/m2 to gange daglig.
English: General disorders and administration site conditions Asthenia
Danish: Almene symptomer og reaktioner på administrations-stedet Asteni
English: • Do not use after the expiry date stated on the carton and bottle label (EXP).
Danish: • Brug ikke CellCept efter den udløbsdato, der står på pakningen og flaskeetiketten efter EXP.
English: The full name of your medicine is CellCept 500 mg film-coated tablets.
Danish: Medicinens fulde navn er CellCept 500 mg filmovertrukne tabletter.
English: • Do not mix the medicine with any other liquid when you swallow it. Close the bottle with the child safety bottle cap after each use.
Danish: • Lad være med at blande medicinen med anden væske, når du synker den.
English: A kidney or liver.
Danish: • Nyre eller lever.
English: Advice that patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
Danish: • Vejledning om, at patienter ikke må være bloddonorer under behandlingen og i mindst 6 uger efter, at mycophenolat er seponeret .
English: The usable volume of the reconstituted suspension is 160-165 ml.
Danish: Efter rekonstitution er suspensionens volumen 175 ml svarende til et nyttevolumen på 160-165 ml.
English: CellCept 500 mg powder for concentrate for solution for infusion must be given as an intravenous (IV) infusion.
Danish: CellCept 500 mg pulver til koncentrat til infusionsvæske, opløsning, skal gives som intravenøs infusion.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral administration
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Oral anvendelse