FrancophonIA/ELRC3.0 huggingface dataset:
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 haematopoietic and lymphoid systems were the primary organs affected in toxicology studies conducted with mycophenolate mofetil in the rat, mouse, dog and monkey.
Danish: De hæmopoietiske og lymfoide organsystemer var de første primære organer der blev påvirket i de toksikologiske undersøgelser, der blev foretaget med mycophenolatmofetil på rotter, mus, hunde og aber.
English: Cases of hepatitis due to reactivation of hepatitis B or hepatitis C have been reported in carrier patients treated with immunosuppressants.
Danish: Tilfælde med hepatitis skyldes reaktivering af hepatitis B eller hepatitis C har været rapporteret hos smittebærende patienter, der har været behandlet med immunosuppressiva.
English: EU/1/10/647/004 (300 hard capsules)
Danish: EU/1/10/647/004 (300 hårde kapsler)
English: These effects can be related to the pharmacodynamic mode of action, i.e. inhibition of nucleotide synthesis in sensitive cells.
Danish: Det kan skyldes den farmakodynamiske effekt, dvs. hæmning af nukleotidsyntesen i sensitive celler.
English: Hypersensitivity reactions, including angioneurotic oedema and anaphylactic reaction have been reported.
Danish: Hypersensitive reaktioner, herunder angioneurotisk ødem og anafylaktiske reaktioner, er blevet rapporteret.
English: In cases of sustained, clinically relevant hypogammaglobulinaemia, appropriate clinical action should be considered taking into account the potent cytostatic effects that mycophenolic acid has on T and B lymphocytes.
Danish: I tilfælde af vedvarende, klinisk relevant hypogammaglobulinæmi skal passende kliniske tiltag overvejes under hensyntagen til den potente cytostatiske virkning, mycophenolsyre har på T-og B-lymfocytter.
English: The effect of sunlight
Danish: Hvordan sollys påvirker dig
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 andre stoffer, der udskilles ved tubulær sekretion.
English: • Your womb (uterus) has been removed by surgery (hysterectomy)
Danish: • Din livmoder (uterus) er blevet fjernet ved operation (hysterektomi)
English: PRCA may resolve with dose reduction or cessation of Myclausen therapy.
Danish: PRCA kan forsvinde ved reduktion af dosis eller ved ophør af Myclausen behandling.
English: As can happen in patients taking this type of medicine (immune-suppressants), a very small number of Myclausen 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 Myclausen-patienter udviklet kræft i lymfevæv og hud.
English: Higher aciclovir plasma concentrations were observed when mycophenolate mofetil was administered with aciclovir in comparison to the administration of aciclovir alone.
Danish: Der blev observeret højere aciclovir plasmakoncentrationer, når mycophenolatmofetil blev administreret sammen med aciclovir sammenlignet med administration af aciclovir alene.
English: Caution should be used during concomitant administration because of the potential to reduce efficacy of Myclausen.
Danish: Der skal udvises forsigtighed ved samtidig administration pga. risikoen for nedsat effekt af Myclausen.
English: • Congenital heart disease such as atrial and ventricular septal defects;
Danish: • medfødt hjertesygdom såsom atriale og ventrikulære septum defekter;
English: Common Hypotension, hypertension, vasodilatation
Danish: Meget almindelig Almindelig Hypotension, hypertension, vasodilatation
English: This includes diarrhoea, infections, fewer white cells and fewer red cells in the blood.
Danish: Disse inkluderer diarré, infektioner, færre hvide og røde blodlegemer i blodet.
English: Additional precautions
Danish: Yderligere forsigtighedsregler
English: Patients receiving Myclausen should be monitored for neutropenia, which may be related to Myclausen itself, concomitant medications, viral infections, or some combination of these causes.
Danish: Patienter, der får Myclausen, bør monitoreres for neutropeni, som kan relateres til Myclausen, samtidig medicin, virale infektioner eller en eller anden kombination af disse årsager.
English: • sinus problems.
Danish: • problemer med bihulerne.
English: Changes to Myclausen therapy should only be undertaken under appropriate supervision in transplant recipients in order to minimise the risk of graft rejection (see section 4.8).
Danish: Ændringer i behandlingen med Myclausen må kun foretages under tilstrækkelig overvågning af den transplanterede patient, så risikoen for afstødning af transplantatet minimeres (se pkt 4.8).
English: It will be explained that the correct course of action, based on an assessment of the individual benefit-risk, will be determined on a case by case basis through a discussion between the treating physician and the patient.
Danish: Det skal forklares, at den bedste fremgangsmåde, vil blive fastlagt fra tilfælde til tilfælde, gennem en diskussion mellem den behandlende læge og patienten og baseret på fordele versus risici for den enkelte patient,
English: • The need to avoid foetal exposure: Contraceptive requirements for patients of reproductive potential prior to, during and after treatment with mycophenolate mofetil.
Danish: • Nødvendigheden af at undgå føtal eksponering: Kravene til prævention for fertile patienter før, under og efter behandling med mycophenolatmofetil.
English: Patients receiving Myclausen should be instructed to report immediately any evidence of infection, unexpected bruising, bleeding or any other manifestation of bone marrow depression.
Danish: Patienter, som får Myclausen, skal have besked om straks at indberette alle tegn på infektion, uventede blodudtrækninger, blødning eller andre manifestationer af knoglemarvsdepression.
English: This medicine does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaring.
English: In volunteers with alcoholic cirrhosis, hepatic MPA glucuronidation processes were relatively unaffected by hepatic parenchymal disease.
Danish: Hos frivillige med alkoholisk cirrhose var de hepatiske MPA glucuronideringsprocesser forholdsvis upåvirkede af den hepatiske parenkymsygdom.
English: Mycophenolate causes a very high frequency of miscarriage (50%) and of severe birth defects (2327%) in the unborn baby.
Danish: Mycophenolat forårsager en meget høj frekvens af aborter (50%) og svære misdannelser (23-27%) hos det ufødte barn.
English: Serious life-threatening infections including meningitis, endocarditis, tuberculosis and atypical mycobacterial infection.
Danish: Alvorlige livstruende infektioner inklusive meningitis, endocarditis, tuberkulose og atypisk mycobakteriel infektion.
English: • Your fallopian tubes and both ovaries have been removed by surgery (bilateral salpingooophorectomy)
Danish: • Dine æggeledere og begge æggestokke er blevet fjernet ved operation (bilateral salpingoooforektomi)
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: Treatment will continue for as long as you need to prevent you from rejecting your transplant organ.
Danish: Behandlingen skal fortsætte så længe, at du har behov, for at forhindre, at du afstøder det transplanterede organ.
English: • fluid on the lungs or inside the chest
Danish: • vand i lungerne eller inde i brysthulen
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på producenter, der er ansvarlige for batchfrigivelse
English: Myclausen capsules should only be prescribed to patients with a body surface area of at least 1.25 m 2.
Danish: Myclausen kapsler må kun ordineres til patienter med en legemsoverflade på mindst 1,25 m2.
English: Therefore, it should be avoided in patients with rare hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT) such as Lesch-Nyhan and Kelley-Seegmiller syndrome.
Danish: Det bør undgås til patienter med sjælden arvelig mangel på hypoxantin-guanin-fosforibosyltransferase (HGPRT) såsom Lesch-Nyhan og Kelley-Seegmiller syndrom.
English: Mycophenolate causes birth defects and miscarriage.
Danish: Mycophenolat forårsager medfødte misdannelser og abort.
English: The recommended dose is 600 mg per taken twice a day.
Danish: Den anbefalede dosis er 600 mg/m to gange daglig.
English: MPA is metabolised principally by glucuronyl transferase (isoform UGT1A9) to form the inactive phenolic glucuronide of MPA (MPAG).
Danish: MPA metaboliseres hovedsageligt af glucuronyltransferase (isoform UGT1A9) til et inaktivt phenolglukuronid af MPA (MPAG).
English: Conversely, changes of MPA exposure should be expected when switching patients from CsA to one of the immunosuppressants which does not interfere with MPA´s enterohepatic cycle.
Danish: Ligeledes bør der forventes ændringer i eksponeringen af MPA hos patienter, som skifter fra CsA til et af de immunsuppressiva, som ikke intefererer med MPAs enterohepatiske kredsløb.
English: However, norfloxacin and metronidazole combined reduced the MPA exposure by approximately 30 % following a single dose of mycophenolate mofetil.
Danish: Kombinationen af norfloxacin og metronidazol reducerede imidlertid MPA-eksponeringen med ca. 30 % efter én mycophenolatmofetil-dosis.
English: There is no basis for Myclausen dose adjustment following cardiac transplant rejection.
Danish: Der er ikke grundlag for justering af Myclausen dosis efter afstødning af hjertetransplantat.
English: • Malformations of the fingers (e.g. polydactyly, syndactyly);
Danish: • misdannelser af fingre ( f.eks. polydaktyli, syndaktyli);
English: Pharmacotherapeutic group: immunosuppressants, selective immunosuppressants, ATC code: L04AA06
Danish: Farmakoterapeutisk klassifikation: immunsuppresiva, selektive immunsuppresiva, ATC-kode: L04AA06
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 MPA-AUC 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: Organic anion-transporting polypeptides (OATPs) and multidrug resistance-associated protein 2 (MRP2) are involved in MPA's disposition; OATP isoforms, MRP2 and breast cancer resistance protein (BCRP) are transporters associated with the glucuronides' biliary excretion.
Danish: Organisk aniontransporterende polypeptider (OATer) og multidrug resistance protein 2 (MRP2) er involverede i fordelingen af MPA; OATP isoformer, MRP2 og brystcancer-resistent protein er transportører som er associeret med glukoroniders galdesekretion.
English: Some of the more usual problems are diarrhoea, fewer white cells or red cells in your blood, infection and vomiting.
Danish: Nogle af de mere sædvanlige problemer er diarré, færre hvide eller røde blodlegemer i blodet, infektion og opkastning.
English: Leucopenia, thrombocytopenia, anaemia Common Pancytopenia, leukocytosis
Danish: Leukopeni, trombocytopeni, anæmi Almindelig Pancytopeni, leukocytose
English: • shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung).
Danish: • kortåndethed, hoste, som kan skyldes bronkiektasi (en tilstand, hvor luftvejene i lungerne er unormalt udvidede) eller lungefibrose (ardannelse i lungerne).
English: Haemodialysis would not be expected to remove clinically significant amounts of MPA or MPAG.
Danish: Hæmodialyse forventes ikke at kunne fjerne klinisk signifikante mængder af MPA eller MPAG.
English: In healthy volunteers, no significant interaction was observed when mycophenolate mofetil was concomitantly administered with norfloxacin or metronidazole separately.
Danish: Der blev ikke observeret nogen signifikant interaktion hos raske frivillige, når mycophenolatmofetil blev administreret samtidigt med norfloxacin eller metronidazol hver for sig.
English: This includes infections of the brain, skin, mouth, stomach and gut, lungs and urinary system.
Danish: Dette inkluderer infektioner i hjernen, huden, munden, maven og tarmene, lungerne og urinvejene.
English: Heart and blood vessel problems such as: • change in blood pressure, unusual heartbeat, widening of blood vessels.
Danish: Lidelser i hjerte og blodkar såsom: • ændringer i blodtrykket, unormale hjerteslag, udvidelse af blodkar
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER, ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE LEVERING OG ANVENDELSE
English: • Abnormalities of the eye (e.g. coloboma);
Danish: • abnormiteter i øjnene (f.eks. coloboma);
English: This section will provide important background information concerning the teratogenicity and mutagenicity of mycophenolate mofetil.
Danish: Dette afsnit skal give vigtig baggrundsinformation om mycophenolatmofetils teratogenicitet og mutagenicitet.
English: Mycophenolate mofetil had no effect on fertility of male rats at oral doses up to 20 mg/kg/day.
Danish: Mycophenolatmofetil havde ingen effekt på fertiliteten hos hanrotter i orale doser op til 20 mg/kg/dag.
English: • congenital choroid plexus cyst;
Danish: • medfødt plexus choriodeus-cyste;
English: In the early post-transplant period (< 40 days post-transplant), renal, cardiac and hepatic transplant patients had mean MPA AUCs approximately 30 % lower and Cmax approximately 40 % lower compared to the late post-transplant period (3-6 months post-transplant).
Danish: I den tidlige posttransplantationsperiode (< 40 dage efter transplantationen) var den gennemsnitlige MPA-AUC hos nyre-, hjerte- og levertransplanterede patienter ca. 30 % lavere og Cmax ca. 40 % lavere sammenlignet med den sene posttransplantationsperiode (3-6 måneder efter transplantationen).
English: Physicians should ensure that women taking mycophenolate understand the risk of harm to the baby, the need for effective contraception, and the need to immediately consult their physician if there is a possibility of pregnancy.
Danish: Lægen skal sikre, at kvinder, som tager mycophenolat, forstår risikoen for skader hos barnet, nødvendigheden af sikker prævention og nødvendigheden af at kontakte lægen straks, hvis der er risiko for graviditet.
English: Oral contraceptives
Danish: Orale antikonceptionsmidler
English: In patients with renal impairment in whom Myclausen 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 Myclausen og ganciclovir, eller dets prodrugs, f.eks. valganciclovir, samtidig bør dosisanbefalingerne for ganciclovir følges, og patienterne bør monitoreres omhyggeligt.
English: Two complementary forms of contraception simultaneously are preferred to minimise the potential for contraceptive failure and unintended pregnancy.
Danish: Samtidig brug af to komplementære former for antikonception fortrækkes for at minimere risikoen for svigt i prævention og utilsigtet graviditet.
English: • Microphthalmia;
Danish: • mikroftalmi;
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppering er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Mycophenolate is a powerful human teratogen, with an increased risk of spontaneous abortions and congenital malformations in case of exposure during pregnancy;
Danish: Mycophenolat har en potent teratogen virkning hos mennesker med en øget risiko for spontane aborter og medfødte misdannelser ved eksponering under graviditet:
English: 1 What Myclausen is and what it is used for 2 What you need to know before you take Myclausen 3 How to take Myclausen 4 Possible side effects
Danish: 1 Virkning og anvendelse 2 Det skal du vide, før du begynder at tage Myclausen 3 Sådan skal du tage Myclausen 4 Bivirkninger
English: 6.6 Special precautions for disposal and other handling Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Danish: 6.6 Regler for destruktion og anden håndtering Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: Each carton contains either 100 or 300 capsules.
Danish: Hver karton indeholder enten 100 eller 300 kapsler.
English: Gingival hyperplasia (≥ 1/100 to < 1/10), colitis including cytomegalovirus colitis, (≥ 1/100 to < 1/10), pancreatitis, (≥ 1/100 to < 1/10) and intestinal villous atrophy.
Danish: Gingival hyperplasi (≥ 1/100 til < 1/10), colitis inklusive cytomegalovirus colitis, (≥ 1/100 til < 1/10, pancreatitis, (≥ 1/100 til < 1/10) og intestinal villøs atrofi.
English: Oral Myclausen should be initiated within 72 hours following transplantation.
Danish: Behandling med oralt Myclausen bør påbegyndes inden for 72 timer efter transplantation.
English: Reports of overdoses with mycophenolate mofetil have been received from clinical trials and during post-marketing experience.
Danish: Der er modtaget rapporter om overdosering med mycophenolatmofetil fra kliniske undersøgelser og efter markedsføring.
English: Talk to your doctor straight away before taking Myclausen:
Danish: Kontakt lægen med det samme, før du tager Myclausen:
English: The available evidence does not indicate an increased risk of malformations or miscarriage if the father takes mycophenolate.
Danish: Tilgængelige data indikerer ikke øget risiko for misdannelser eller abort hvis faderen tager mycophenolat.
English: Contraception in men taking Myclausen
Danish: Prævention hos mænd, som tager Myclausen
English: If neutropenia develops, dosing with Myclausen should be interrupted or the dose reduced (see section 4.4).
Danish: Hvis der udvikles neutropeni, skal administrationen af Myclausen afbrydes eller dosis nedsættes (se pkt.
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 omfatter latent viral reaktivering, såsom hepatitis B eller hepatitis Creaktivering og infektioner forårsaget af polyomaviruses (BK-virus associeret med nefropati og JCvirus associeret med progressiv multifokal leukoencefalopati PML).
English: PHARMACEUTICAL FORM AND CONTENTS 100 hard capsules
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 100 hårde kapsler
English: Fighting infections
Danish: Bekæmpelse af infektioner
English: Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose.
Danish: Gastrointestinale virkninger observeredes hos hunde ved systemiske niveauer lig med eller mindre end det kliniske niveau ved den anbefalede dosis.
English: The educational programme is aimed at ensuring that the health professionals and patients are aware of the teratogenicity and mutagenicity, the need for pregnancy tests before starting therapy with mycophenolate mofetil, the contraceptive requirements for both male and female patients and what to do in case of pregnancy during treatment with Myclausen.
Danish: Uddannelsesprogrammets formål er at sikre, at sundhedspersoner og patienter er bevidste om teratogeniciteten og mutageniciteten, nødvendigheden af graviditetstests, før behandlingen initieres, kravene til prævention for både mandlige og kvindelig patienter, og hvilke tiltag der skal initieres, hvis der opstår graviditet under behandling med Myclausen.
English: Each carton contains either 50 or 150 tablets.
Danish: Hver karton indeholder enten 50 eller 150 tabletter.
English: Treatment during rejection episodes
Danish: Behandling under afstødningsepisoder
English: For contraception advice for men see section 4.6.
Danish: For antikonceptionelle råd til mænd, se pkt.
English: Do not take Myclausen
Danish: Tag ikke Myclausen
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOIL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERFOLIE
English: There are no data on mycophenolate mofetil with phosphate binders other than sevelamer.
Danish: Der er ingen data for administrationen af mycophenolatmofetil med andre phosphatbindere end sevelamer.
English: Oblong, white capsules.
Danish: Aflange, hvide kapsler.
English: Because MPAG plasma concentrations are increased in the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs, e.g. valaciclovir, to compete for tubular secretion and further increases in concentrations of both substances may occur.
Danish: Da MPAG plasmakoncentrationer forhøjes ved nedsat nyrefunktion, lige som aciclovir-koncentrationerne bliver det, er der en mulighed for, at mycophenolatmofetil og aciclovir, eller dets prodrugs, f.eks. valaciclovir, vil konkurrere om den tubulære sekretion, og at der kan ske yderligere forhøjelser af koncentrationerne af begge stoffer.
English: Myclausen contains sodium
Danish: Myclausen indeholder natrium
English: • Facial malformations such as cleft lip, cleft palate, micrognathia and hypertelorism of the orbits;
Danish: • misdannelser i ansigtet såsom læbespalte, ganespalte, mikrognati og hypertelorisme;
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Denne medicin indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. den er i det væsentlige natriumfri.
English: No substantial alteration of MPA pharmacokinetics is anticipated and Myclausen dose adjustment is not required.
Danish: Der forudses ingen væsentlig ændring af MPA's farmakokinetik og dosisjustering af Myclausen er ikke nødvendig.
English: • If you have a sign of infection such as a fever or sore throat
Danish: • hvis du har tegn på infektion såsom feber eller ondt i halsen
English: • You miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant.
Danish: • du ikke får din menstruation eller tror, du ikke har fået din menstruation eller har en usædvanlig menstruation eller tror, at du er gravid
English: Do not take Myclausen if you are breast-feeding.
Danish: Tag ikke Myclausen, hvis du ammer.
English: Medicinal products that interfere with enterohepatic circulation Caution should be used with medicinal products that interfere with enterohepatic circulation because of their potential to reduce the efficacy of Myclausen.
Danish: Lægemidler som interfererer med den enterohepatiske cirkulation Der skal udvises forsigtighed med lægemidler, som interfererer med den enterohepatiske cirkulation pga. risikoen for nedsat effekt af Myclausen.