FrancophonIA/ELRC3.0 huggingface dataset:
English: Package leaflet: Information for the user Mycophenolate mofetil Teva 500mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Mycophenolate mofetil Teva 500 filmovertrukne tabletter
English: However, keep taking Mycophenolate mofetil Teva until you see him or her.
Danish: Fortsæt dog behandlingen med Mycophenolate mofetil Teva, indtil du ser lægen.
English: Mycophenolate mofetil Teva is contraindicated during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
Danish: Mycophenolate mofetil Teva er kontraindiceret under graviditeten, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet.
English: Package leaflet: Information for the user Mycophenolate mofetil Teva 250 mg hard capsules
Danish: Indlægsseddel: Information til brugeren Mycophenolate mofetil Teva 250 mg kapsler, hårde
English: Men must not donate semen during treatment with Mycophenolate mofetil Teva and for at least 90°days after stopping treatment.
Danish: Mænd må ikke være sæddonorer under behandling med Mycophenolate mofetil Teva og i mindst 90 dage efter behandlingens ophør.
English: Therefore, a change in the dose of Mycophenolate mofetil Teva 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: Mycophenolate mofetil Teva 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: Mycophenolate mofetil Teva må ikke anvendes til patienter med overfølsomhed over for mycophenolatmofetil, mycophenolsyre eller over for et eller flere af hjælpestofferne anført i pkt.
English: Dose adjustment of Mycophenolate mofetil Teva does not appear to be necessary.
Danish: Justering af Mycophenolate mofetil Teva-dosis er ikke nødvendig.
English: There have been published reports of bronchiectasis in adults and children who received mycophenolate mofetil in combination with other immunosuppressants.
Danish: Der er publicerede tilfælde af bronkiektasi hos voksne og børn, der har fået mycophenolatmofetil i kombination med andre immunsuppressiva.
English: Based on the results of a single dose administration study of recommended doses of oral mycophenolate mofetil and intravenous ganciclovir and the known effects of renal impairment on the pharmacokinetics of mycophenolate mofetil (see section 4.2) and ganciclovir, it is anticipated that coadministration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.
Danish: Baseret på resultaterne fra et studie med enkelt dosis indgift af anbefalede doser af oral mycophenolatmofetil og intravenøs ganciclovir og de kendte virkninger af nedsat nyrefunktion på mycophenolatmofetils og ganciclovirs farmakokinetik (se pkt.
English: These changes may suggest a ‘left shift' in the maturity of neutrophils in haematological investigations, which may be mistakenly interpreted as a sign of infection in immunosuppressed patients such as those that receive Mycophenolate mofetil Teva.
Danish: Sådan et blodbillede kan fejlagtigt blive tolket som et tegn på infektion hos immunsupprimerede patienter, som dem der behandles med Mycophenolate mofetil Teva.
English: Oral Mycophenolate mofetil Teva should be initiated within 5 days following transplantation.
Danish: Oralt Mycophenolate mofetil Teva bør gives indenfor 5 døgn efter transplantation.
English: Elderly patients receiving Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva som led i et immunsuppressivt kombinationsregime, kan have større risiko for bivirkninger, såsom visse infektioner (inklusive vævsinvasiv sygdom forårsaget af cytomegalovirus) og muligvis gastrointestinal blødning og lungeødem, sammenlignet med yngre individer.
English: Mycophenolate mofetil Teva treatment should not be initiated in women of child bearing potential without providing a pregnancy test result to rule out unintended use in pregnancy (see section 4.6).
Danish: Mycophenolate mofetil Teva-behandling må ikke initieres hos kvinder i den fertile alder uden at en negativ graviditetstest foreligger, for at udelukke en uønsket anvendelse under graviditet (se pkt.
English: Mycophenolate mofetil Teva 250 mg hard capsules are available in PVC/PVdC-aluminium blisters in pack sizes of 100 or 300 or 100 x 1 capsules per carton.
Danish: Mycophenolate mofetil Teva 250 mg kapsler, hårde fås i PVC/PVdC-aluminium blister i pakningsstørrelser på 100 eller 300 eller 100x1 kapsler pr. karton.
English: You must not donate blood during treatment with Mycophenolate mofetil Teva and for at least 6 weeks after stopping treatment.
Danish: Du må ikke give blod under behandling med Mycophenolate mofetil Teva og i mindst 6 uger efter behandlingens ophør.
English: Intravenous mycophenolate mofetil should be administered for the first 4°days following hepatic transplant, with oral Mycophenolate mofetil Teva initiated as soon after this as it can be tolerated.
Danish: Mycophenolatmofetil skal gives intravenøst i de 4 første dage efter en levertransplantation og herefter skal oral administration påbegyndes så snart det tåles.
English: Mycophenolate mofetil Teva 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: Mycophenolate mofetil Teva 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: Mycophenolate mofetil Teva should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
Danish: Mycophenolate mofetil Teva må ikke anvendes hos kvinder i den fertile alder, som ikke anvender meget sikker kontraception (se pkt.
English: Contraception in men taking Mycophenolate mofetil Teva
Danish: Prævention hos mænd, som tager Mycophenolate mofetil Teva
English: Transparent PVC/PVdC-aluminium blisters in pack sizes of 50 or 150 or 50 x 1 tablets per carton.
Danish: Transparent PVC/PVdC-aluminium blister i pakningsstørrelser af 50 eller 150 eller 50x1 tabletter pr.
English: The most common opportunistic infections in patients receiving mycophenolate mofetil (2°g or 3°g daily) with other immunosuppressants in controlled clinical trials in renal (2°g data), cardiac and hepatic transplant patients followed for at least 1°year were candida mucocutaneous, cytomegalovirus (CMV) viraemia/syndrome and Herpes simplex.
Danish: I kontrollerede kliniske studier hos nyre- (2 g data), hjerte- og levertransplantationspatienter, som blev fulgt i mindst 1 år, var de almindeligste opportunistiske infektioner hos patienter, som fik mycophenolatmofetil (2 g eller 3 g daglig) sammen med andre immunsupprimerende stoffer, mukokutane candidainfektioner, cytomegalovirus (CMV) viræmi/syndrom og herpes simplex infektioner.
English: Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia Psychiatric disorders Very commonCommon
Danish: Acidose, hyperkaliæmi, hypokaliæmi, hyperglykæmi, hypomagnesæmi, hypokalcæmi, hyperkolesterolæmi, hyperlipæmi, hypofosfatæmi, hyperurikæmi, arthritis urica, anoreksi
English: Contents of the pack and other information What Mycophenolate mofetil Teva contains
Danish: Pakningsstørrelser og yderligere oplysninger Mycophenolate mofetil Teva indeholder:
English: Mycophenolate mofetil Teva 250 mg Capsules
Danish: Mycophenolate mofetil Teva 250 mg kapsler
English: Transparent PVC/PVdC - aluminium blisters in pack sizes of 100 or 300 or 100 x 1 capsules per carton.
Danish: Transparent PVC/PVdC-aluminium blister i pakningsstørrelser af 100 eller 300 eller 100x1 kapsler pr.
English: Mycophenolate mofetil Teva should not be given to women who are breastfeeding (see section 4.6).
Danish: Mycophenolate mofetil Teva må ikke anvendes til ammende kvinder (se pkt.
English: There have been reports of hypogammaglobulinaemia in association with recurrent infections in patients receiving mycophenolate mofetil in combination with other immunosuppressants.
Danish: Der er rapporteret hypogammaglobulinæmi i forbindelse med tilbagevendende infektioner hos patienter, der har fået mycophenolatmofetil i kombination med andre immunsuppressiva.
English: The active substance in this medicine is called mycophenolate mofetil. Mycophenolate mofetil Teva is used to prevent your body rejecting a transplanted kidney, heart or liver.
Danish: Mycophenolate mofetil Teva anvendes til at forhindre kroppen i at afstøde en transplanteret nyre, hjerte eller lever.
English: Do not take Mycophenolate mofetil Teva if you are breast-feeding.
Danish: Tag ikke Mycophenolate mofetil Teva, hvis du ammer.
English: Mycophenolate mofetil Teva should not be used during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6).
Danish: Mycophenolate mofetil Teva må ikke anvendes under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet (se pkt.
English: Patients receiving immunosuppressive regimens involving combinations of medicinal products, including Mycophenolate mofetil Teva, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.8).
Danish: Patienter, der får immunsuppressiv behandling med kombinationer af lægemidler, som inkluderer, Mycophenolate mofetil Teva har forøget risiko for at udvikle lymfomer og andre maligne lidelser, især i huden (se pkt.
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 nyre transplantationspatienter der fik den anbefalede kliniske dosis på 2 g daglig og 1,3-2 gange den systemiske eksponering (AUC eller Cmax) observeret hos hjerte transplantationspatienter der fik den anbefalede kliniske dosis på 3 g daglig.
English: Convulsion, hypertonia, tremor, somnolence, myasthenic syndrome, dizziness, headache, paraesthesia, dysgeusia
Danish: Kramper, hypertoni, tremor, somnolens, muskelsvaghed, svimmelhed, hovedpine, paræstesier, smagsforstyrrelser
English: Decrease in MPA Cmax and AUC0-12h by 30% and 25%, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i.e. graft rejection).
Danish: Når mycophenolatmofetil blev administreret samtidig med sevelamer, faldt MPA- Cmax og AUC0-12timer med henholdsvis 30 % og 25 %, dog uden at dette havde kliniske konsekvenser (f.eks. i form af transplantatafstødning).
English: If you forget to take Mycophenolate mofetil Teva
Danish: Hvis du har glemt at tage Mycophenolate mofetil Teva
English: Congenital malformations have been observed post-marketing in children of patients exposed to mycophenolate mofetil 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 mycophenolatmofetil i kombination med andre immunsuppressiva, se pkt.
English: If you stop taking Mycophenolate mofetil Teva
Danish: Hvis du holder op med at tage Mycophenolate mofetil Teva
English: Patients with a body surface area greater than 1.5 m2 may be prescribed Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva-kapsler i en dosis på 1 g to gange daglig (daglig dosis: 2 g).
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 Mycophenolate mofetil Teva is not required.
Danish: Afstødning af nyretransplantat medfører ingen ændringer af MPA's farmakokinetik; dosisreduktion eller afbrydelse af Mycophenolate mofetil Teva er ikke nødvendig.
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 nyre transplanterede patienter og 1,3-2 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g daglig til hjerte transplanterede patienter.
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 for renal transplant patients and approximately 0.3°times the clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients (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 til nyre transplanterede patienter og ca. 0,3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g daglig til hjertetransplanterede patienter (se pkt.
English: What you need to know before you take Mycophenolate mofetil Teva
Danish: Det skal du vide, før du begynder at tage Mycophenolate mofetil Teva
English: Mycophenolate mofetil Teva 500 mg film-coated tablets Mycophenolate mofetil
Danish: Mycophenolate mofetil Teva 500 mg filmovertrukne tabletter Mycophenolatmofetil
English: When comparing rates of transplant rejection or rates of graft loss between mycophenolate mofetil patients taking PPIs vs. mycophenolate mofetil 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 mycophenolatmofetil-patienter, som tog protonpumpehæmmer versus mycophenolatmofetil-patienter, som ikke tog protonpumpehæmmer.
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 mycophenolate mofetil 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 mycophenolatmofetil to gange daglig.
English: The systemic exposure at this dose was approximately 0.5°times the clinical exposure at the recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3°times the clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients.
Danish: Den systemiske eksponering af denne dosis var ca. 0,5 gange den kliniske eksponering af den anbefalede kliniske dosis på 2 g daglig til nyre transplanterede patienter og ca. 0,3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g daglig til hjerte transplantationspatienter.
English: The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).
Danish: Den anbefalede dosis til nyretransplantationspatienter er 1 g administreret to gange daglig (døgndosis, 2 g).
English: Therefore women with childbearing potential must use at least one form of reliable contraception (see section 4.3) before starting Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva påbegyndes, under behandlingen og i seks uger efter behandlingsophør, medmindre seksuel afholdenhed er den valgte form for kontraception.
English: Other medicines and Mycophenolate mofetil Teva
Danish: Brug af anden medicin sammen med Mycophenolate mofetil Teva
English: Mycophenolate mofetil Teva 500 mg Film-coated Tablets
Danish: Mycophenolate mofetil Teva 500 mg filmovertrukne tabletter
English: Mycophenolate mofetil Teva 250mg hard capsules Mycophenolate mofetil
Danish: Mycophenolate mofetil Teva 250 mg kapsler, hårde Mycophenolatmofetil
English: Do not take Mycophenolate mofetil Teva,
Danish: Tag ikke Mycophenolate mofetil Teva
English: In some of these cases switching mycophenolate mofetil to another immunosuppressant resulted in improvement in respiratory symptoms.
Danish: I nogle af disse tilfælde sås forbedringer i de respiratoriske symptomer, når mycophenolatmofetil blev erstattet af alternative immunsuppressiva.
English: Mycophenolate mofetil Teva 250 mg hard capsules
Danish: Mycophenolate mofetil Teva 250 mg kapsler, hårde
English: Severe hepatic impairment
Danish: Psykiske forstyrrelser Meget almindeligAlmindelig
English: Patients with a body surface area of 1.25 to 1.5 m2 may be prescribed Mycophenolate mofetil Teva capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Danish: Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva -kapsler i en dosis på 750 mg to gange daglig (daglig dosis: 1,5 g).
English: The recommended dose in cardiac transplant patients is 1.5°g administered twice daily (3°g daily dose).
Danish: Den anbefalede dosis til hjertetransplantationspatienter er 1,5 g administreret to gange daglig (døgndosis, 3 g).
English: • The active substance is mycophenolate mofetil.
Danish: - Aktivt stof: mycophenolatmofetil.
English: In some of these cases switching mycophenolate mofetil to an alternative immunosuppressant resulted in serum IgG levels returning to normal.
Danish: I nogle af disse tilfælde blev serum-IgG normaliseret, når mycophenolatmofetil blev erstattet af alternative immunsuppressiva.
English: Lymphoproliferative disease or lymphoma developed in 0.6% of patients receiving mycophenolate mofetil (2°g or 3°g daily) in combination with other immunosuppressants in controlled clinical trials of renal (2°g data), cardiac and hepatic transplant patients followed for at least 1°year.
Danish: I kontrollerede kliniske studier hos nyre- (2 g data), hjerte- og levertransplanterede patienter som kontrolleredes i mindst 1 år udvikledes lymfoproliferativ sygdom eller lymfomer hos 0,6 % af de patienter som fik mycophenolatmofetil (2 eller 3 g daglig) sammen med andre immunsuppressive stoffer.
English: How to take Mycophenolate mofetil Teva
Danish: Sådan skal du tage Mycophenolate Mofetil Teva
English: What Mycophenolate mofetil Teva is and what it is used for What you need to know before you take Mycophenolate mofetil Teva How to take Mycophenolate mofetil Teva Possible side effects
Danish: Det skal du vide, før du begynder at tage Mycophenolate mofetil Teva Sådan skal du tage Mycophenolate mofetil Teva Bivirkninger
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: Hvis det er tilfældet, skal en graviditetstest udføres umiddelbart før behandlingen initieres og en yderligere test udføres 8-10 dage senere.
English: The recommended oral dose in hepatic transplant patients is 1.5°g administered twice daily (3°g daily dose).
Danish: Den anbefalede orale Mycophenolate mofetil Teva dosis til levertransplantationspatienter er 1,5 g to gange daglig (en døgndosis på 3 g).
English: Hepatitis, jaundice, hyperbilirubinaemia
Danish: Hepatitis, icterus, hyperbilirubinæmi Hud og subkutane væv Meget almindeligAlmindelig
English: Very common Vomiting, abdominal pain, diarrhoea, nausea Common
Danish: Pleural effusion, dyspnø, hoste Mave-tarm-kanalen Meget almindelig Opkastning, abdominalsmerter, diarré, kvalme Almindelig
English: System organ class Frequency Adverse drug reactions hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia Psychiatric disorders Very commonCommon
Danish: Hudkræft, benignt neoplasme af huden Blod og lymfesystem Meget almindelig Leukopeni, trombocytopeni, anæmi Almindelig
English: Each capsule contains 250 mg mycophenolate mofetil. For the full list of excipients, see section 6.1.
Danish: Hver kapsel indeholder 250 mg mycophenolatmofetil - Øvrige indholdsstoffer:
English: Each dose must be taken with food.
Danish: Hver dosis skal indtages sammen med et måltid.
English: For adults, the recommended dose is 300 mg once a day.
Danish: Den anbefalede dosis for voksne er 300 mg én gang dagligt.
English: A small dose of another medicine, ritonavir, is normally given at the same time as a ‘booster'.
Danish: En lille dosis af et andet lægemiddel, ritonavir, gives normalt samtidigt som en "forstærker".
English: It is used together with low-dose ritonavir and other antiviral medicines to treat patients aged 6 years and over.
Danish: Det anvendes sammen med lavdosis-ritonavir og andre antivirale lægemidler til at behandle patienter i alderen 6 år og derover.
English: Further information on Atazanavir Krka can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/atazanavir-krka.
Danish: Yderligere information vedrørende Atazanavir Krka findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/atazanavir-krka.
English: Atazanavir Krka is available as capsules (150 mg, 200 mg and 300 mg).
Danish: Atazanavir Krka fås som kapsler (150 mg, 200 mg og 300 mg).
English: It blocks an enzyme called protease, which is needed for the HIV virus to multiply.
Danish: Det blokerer et enzym kaldet protease, som hiv-virusset har brug for for at kunne formere sig.
English: This allows a lower dose of atazanavir to be used for the same antiviral effect.
Danish: Dette gør det muligt at anvende en mindre dosis atazanavir, men alligevel opnå den samme antivirale virkning.
English: The medicine is not expected to work in patients in whom many medicines in the same class as Atazanavir Krka (protease inhibitors) do not work.
Danish: Lægemidlet forventes ikke at virke hos patienter, hos hvem mange lægemidler fra samme klasse som Atazanavir Krka (proteasehæmmere) ikke har virket.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Reyataz, and do not need to be repeated for Atazanavir Krka.
Danish: Der er allerede foretaget studier over det aktive stofs fordele og risici ved godkendt brug med referencelægemidlet, Reyataz, og de behøver ikke at blive gentaget for Atazanavir Krka.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Atazanavir Krka has been shown to have comparable quality and to be bioequivalent to Reyataz.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav er påvist, at Atazanavir Krka er af sammenlignelig kvalitet og er bioækvivalent med Reyataz.
English: As for every medicine, the company provided studies on the quality of Atazanavir Krka.
Danish: Som for alle lægemidler har virksomheden leveret studier vedrørende kvaliteten af Atazanavir Krka.