FrancophonIA/ELRC3.0 huggingface dataset:
English: Serum levels of LH, FSH and progesterone were not significantly affected.
Danish: Serum-niveauet af LH, FSH og progesteron blev ikke signifikant påvirket.
English: In this leaflet the shorter name Myclausen is used.
Danish: • I denne indlægsseddel er det kortere navn Myclausen anvendt.
English: Store below 30 °C.
Danish: Opbevares ved temperaturer under 30 °C.
English: If you do not fully understand these instructions, please ask your doctor to explain them again before you take mycophenolate.
Danish: Hvis du ikke helt forstår informationen, skal du bede lægen om at forklare den igen, før du tager mycophenolat.
English: • septum pellucidum agenesis;
Danish: • septum pellucidum agenesi;
English: Most (about 87 %) of the administered dose is excreted in the urine as MPAG.
Danish: Det meste (ca. 87 %) af den administrerede dosis udskilles i urinen som MPAG.
English: • You are a child or teenager who has not started having periods.
Danish: • Du er barn eller teenager og endnu ikke har fået menstruation.
English: There are limited safety and efficacy data in children below the age of 2 years.
Danish: For børn under 2 år er der begrænsede data om sikkerhed og effekt.
English: Elderly patients (≥ 65 years) may generally be at increased risk of adverse reactions due to immunosuppression.
Danish: Ældre patienter (≥ 65 år) har i almindelighed større risiko for uønskede hændelser pga. immunsuppression.
English: See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Danish: Se også ydereligere information i dette afsnit under ”Advarsler og forsigtighedsregler” og ”Graviditet, prævention og amning”.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 7 October 2010
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 7. oktober 2010 Dato for seneste fornyelse: 27. maj 2015
English: For oral use.
Danish: Oral anvendelse.
English: • Renal abnormalities.
Danish: • renale abnormiteter.
English: It is recommended that Myclausen should not be administered concomitantly with azathioprine because such concomitant administration has not been studied.
Danish: Myclausen bør ikke administreres samtidig med azathioprin, da en sådan samtidig administration ikke er blevet undersøgt.
English: Educational materials
Danish: Uddannelsesmateriale
English: MPA at clinically relevant concentrations is 97 % bound to plasma albumin.
Danish: MPA er ved klinisk relevante koncentrationer for 97 %'s vedkommende bundet til plasma-albumin.
English: There have also been reports of bronchiectasis in children and adults (frequency not known).
Danish: Der er også rapporteret bronkiektasi hos børn og voksne (hyppighed ukendt).
English: However, close clinical monitoring should be performed during the combination and shortly after antibiotic treatment.
Danish: Derimod skal der ske en tæt klinisk monitorering under behandlingskombinationen og kort tid efter den antibiotiske behandling.
English: Do not stop taking Myclausen unless your doctor tells you to.
Danish: Stop ikke med at tage Myclausen, medmindre lægen har bedt dig om det.
English: Myclausen is used to prevent your body rejecting a transplanted organ.
Danish: Myclausen anvendes til at forhindre din krop i at afstøde et transplanteret organ.
English: • You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner's syndrome or uterine agenesis
Danish: • Du blev født med en af følgende sjældne tilstande, som gør graviditet umulig: XY-genotype, Turners syndrom eller manglende livmoder
English: It is recommended, however, to administer Myclausen at least one hour before or three hours after sevelamer intake to minimise the impact on the absorption of MPA.
Danish: Myclausen bør imidlertid administreres mindst én time før eller tre timer efter indtagelsen af sevelamer for at minimere dets indvirkning på MPA-absorptionen.
English: Myclausen with food and drink Taking food and drink has no effect on your treatment with Myclausen.
Danish: Brug af Myclausen sammen med mad og drikke Indtagelse af mad og drikke har ingen virkning på din behandling med Myclausen.
English: Patients taking oral contraceptives
Danish: Patienter som tager orale kontraceptiva
English: This is because Myclausen can affect the way some other medicines work.
Danish: Dette skyldes, at Myclausen kan påvirke den måde, anden medicin virker på.
English: As a result of enterohepatic recirculation, secondary increases in plasma MPA concentration are usually observed at approximately 6-12 hours post-dose.
Danish: Som et resultat af det enterohepatiske kredsløb observeres sekundære stigninger i plasmakoncentrationen af MPA sædvanligvis omkring 6-12 timer efter indgift.
English: In those overdose cases in which adverse events were reported, the events fall within the known safety profile of the medicinal product.
Danish: I de tilfælde af overdosis, hvor der var uønskede hændelser, fandtes disse at være inden for den kendte sikkerhedsprofil for lægemidlet.
English: • azathioprine or other medicines which suppress your immune system (given after a transplant operation)
Danish: • azathioprin eller anden medicin, som undertrykker immunsystemet (gives efter en transplantation)
English: Non-melanoma skin carcinomas occurred in 3.6 % of patients; other types of malignancy occurred in 1.1 % of patients.
Danish: Non-melanom hudcancer indtraf hos 3,6 % af patienterne og andre maligniteter hos 1,1 %.
English: The risk of bronchiectasis may be linked to hypogammaglobulinaemia or to a direct effect on the lung.
Danish: Risikoen for bronkiektasi kan være knyttet til hypogammaglobulinæmi eller til direkte påvirkning af lungerne.
English: • The dose given will vary depending on the size of the child.
Danish: • Dosis er afhængig af barnets størrelse.
English: As general advice to minimise the risk for skin cancer, exposure to sunlight and UV light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.
Danish: For at minimere risikoen for hudkræft må det generelt tilrådes, at udsættelse for sollys og UV-lys begrænses ved, at der bæres beskyttende beklædning, og ved at der anvendes en solblokker med en høj beskyttelsesfaktor.
English: Patients taking Myclausen 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 på Myclausen bør have foretaget fuldstændig blodtælling hver uge den første måned, to gange om måneden den anden og tredje behandlingsmåned og derefter en gang om måneden igennem det første år.
English: A negligible amount of substance is excreted as MPA (< 1 % of dose) in the urine.
Danish: Ubetydelige mængder af stoffet udskilles som MPA (< 1 % af dosis) i urinen.
English: MPA is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase, and therefore inhibits the de novo pathway of guanosine nucleotide synthesis without incorporation into DNA.
Danish: MPA er en potent, selektiv, ikke-kompetitiv og reversibel inhibitor af inosin-monophosfat-dehydrogenase og hæmmer derfor de novo-vejen for en guanosin-nucleotid-syntese uden inkorporering i DNA.
English: • If you are planning to become pregnant or if you get pregnant while taking Myclausen.
Danish: • hvis du planlægger at blive gravid, eller hvis du bliver gravid, mens du tager Myclausen.
English: These are insufficient to make dosage recommendations and therefore use in this age group is not recommended.
Danish: De er ikke tilstrækkelige til at komme med dosisrekommandationer, og det anbefales derfor ikke at anvende Myclausen til denne aldersgruppe.
English: For patients, the text should be appropriately separated for men and women.
Danish: Informationen til patienter skal være hensigtsmæssig adskilt for henholdsvis mænd og kvinder.
English: Separate guides for healthcare professionals and patients should be provided.
Danish: Der skal udleveres vejledninger til henholdsvis sundhedspersoner og patienter.
English: • Your ovaries no longer work (premature ovarian failure, which has been confirmed by a specialist gynaecologist)
Danish: • Dine æggestokke er ophørt med at fungere (for tidligt ovariesvigt, som er blevet bekræftet af en speciallæge i gynækologi)
English: However, at high MPAG plasma concentrations (> 100 µg/mL), small amounts of MPAG are removed.
Danish: Ved høje MPAG-plasmakoncentrationer (> 100 μg/ml) fjernes dog mindre mængder MPAG.
English: Your doctor will talk to you about the risks in case of pregnancy and the alternatives you can take to prevent rejection of your transplant organ if:
Danish: Lægen vil tale med dig om risici i forbindelse med graviditet og alternative behandlinger, du kan tage for at forhindre afstødning af det transplanterede organ, hvis:
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på blisterkort og karton.
English: This effect tended to diminish with continued antibiotic use and to cease within a few days of antibiotic discontinuation.
Danish: Denne effekt syntes at reduceres ved fortsat brug af antibiotika og forsvandt inden for få dage efter seponering af antibiotika.
English: Two forms of contraception are preferable as this will reduce the risk of unintended pregnancy.
Danish: Brug af to former for prævention er bedre, da dette vil gøre risikoen for utilsigtet graviditet mindre.
English: • You have sex without using an effective method of contraception.
Danish: • hvis du har haft sex uden at anvende effektiv prævention.
English: Patients will be informed that they should not stop taking mycophenolate mofetil but must contact their doctor immediately.
Danish: Patienterne skal informeres om, at de ikke må stoppe med at tage mycophenolatmofetil, men skal kontakte lægen med det samme.
English: Trimethoprim/sulfamethoxazole No effect on the bioavailability of MPA was observed.
Danish: Trimethoprim/sulfamethoxazol Der blev ikke observeret nogen virkning på MPAs biotilgængelighed.
English: A minor acylglucuronide (AcMPAG) is also formed.
Danish: Et acylglukuronid (AcMPAG) bliver også dannet i mindre omfang.
English: No effects on fertility or reproductive parameters were evident in the dams or in the subsequent generation.
Danish: Der var ingen tydelig påvirkning af fertilitets- og reproduktionsparametre hos moderdyrene og den følgende generation.
English: • cholestyramine (used to treat high cholesterol)
Danish: • colestyramin (bruges til behandling af forhøjet kolesterol)
English: Other unwanted effects may include:
Danish: Andre bivirkninger kan omfatte:
English: If you do become pregnant during the treatment with mycophenolate, you must inform your doctor immediately.
Danish: Hvis du bliver gravid under behandlingen med mycophenolat, skal du straks kontakte lægen.
English: Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Inden for hver systemorganklasse er bivirkninger opstillet efter frekvens under anvendelse af følgende kategorier: meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: • Counselling of patients: This section will emphasise the importance of a thorough, informative and ongoing dialogue between patient and healthcare professional about the pregnancy risks associated with mycophenolate mofetil and the relevant minimisation strategies including alternative treatment choices, if applicable.
Danish: • Vejledning til patienter: Dette afsnit skal understrege vigtigheden af en grundig, informativ og løbende dialog mellem patient og sundhedspersoner omkring de graviditetsrisici, der er forbundet med mycophenolatmofetil, og de relevante minimeringsstrategier, herunder alternative behandlingsmuligheder, hvis det er relevant.
English: Also other medicines can affect the way Myclausen works.
Danish: Anden medicin kan også påvirke den måde, Myclausen virker på.
English: • feeling anxious or depressed, changes in your mood or thoughts.
Danish: • følelse af angst eller depression, ændringer i dit humør eller dine tanker.
English: Mycophenolate mofetil is not measurable systemically in plasma following oral administration.
Danish: Mycophenolatmofetil kan ikke måles systemisk i plasma efter oral administration.
English: Take the medicine pack with you.
Danish: Tag pakningen med.
English: Other in vitro tests for detection of gene mutation did not demonstrate genotoxic activity.
Danish: Andre in vitro tests for genmutation kunne ikke påvise genotoksisk aktivitet.
English: In the kidney MPA and its metabolites potently interact with renal organic anion transporters.
Danish: I nyrerne kan MPA og dets metabolitter i vidt omfang interagere med renale organisk aniontransportører.
English: Norfloxacin and metronidazole
Danish: Norfloxacin og metronidazol
English: Treatment with Myclausen should be initiated and maintained by appropriately qualified transplant specialists.
Danish: Behandling med Myclausen bør påbegyndes og fortsættes af specialister med særligt kendskab til transplantationer.
English: Contact your doctor as soon as possible, if you think your contraception may not have been effective or if you have forgotten to take your contraceptive pill.
Danish: Kontakt lægen så hurtig som muligt, hvis du tror at din prævention har svigtet, eller hvis du har glemt at tage de svangerskabsforebyggende tabletter (f.eks. p-piller).
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: If any of the above apply to you (or you are not sure), talk to your doctor straight away before taking Myclausen.
Danish: Hvis noget af ovenstående gælder for dig (eller hvis du er i tvivl), skal du tale med din læge med det samme, før du tager Myclausen.
English: Lymph and skin cancer
Danish: Lymfe- og hudkræft
English: There may be a transient increase in the free fraction and concentration of plasma MPA in patients with delayed renal graft function.
Danish: Der kan være en forbigående stigning i den frie fraktion og i koncentrationen af plasma-MPA hos patienter med forsinket renal transplantatfunktion.
English: • Do not take any capsules that have broken open or split.
Danish: • Indtag ikke kapsler, der er åbnede eller gået itu.
English: The PRAC therefore recommended to amend the product information, to update information on teratogenic effects and pregnancy as well as the contraception recommendations for male patients.
Danish: PRAC anbefalede derfor at ændre produktinformationen, for at opdatere information om teratogen virkning og graviditet, samt præventionsanbefalingerne til mandlige patienter.
English: Your doctor will speak to you and give you written information, particularly on the effects of mycophenolate on unborn babies.
Danish: Lægen vil tale med dig og give dig skriftlig information, især om mycophenolats virkninger på fosteret.
English: Following oral administration, mycophenolate mofetil undergoes rapid and extensive absorption and complete presystemic metabolism to the active metabolite, MPA.
Danish: Efter oral administration gennemgår mycophenolatmofetil en hurtig og udstrakt absorption og fuldstændig præsystemisk metabolisme til den aktive metabolit, MPA.
English: If you need to have a vaccine (a live vaccine) while taking Myclausen, talk to your doctor or pharmacist first.
Danish: Hvis du skal vaccineres (med en levende vaccine), mens du tager Myclausen, skal du tale med lægen eller apoteketspersonalet først.
English: • olfactory nerve agenesis.
Danish: • nervus olfactorius agenesi.
English: However, the following treatment-related adverse events were more frequent in the paediatric population, particularly in children under 6 years of age, when compared to adults: diarrhoea, sepsis, leucopenia, anaemia and infection.
Danish: Imidlertid var følgende behandlingsrelaterede bivirkninger hyppigere i den pædiatriske population, især hos børn under 6 år, sammenlignet med voksne: diarré, sepsis, leukopeni, anæmi og infektion.
English: Teratogenic effects
Danish: Teratogen virkning
English: If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.
Danish: Vask omhyggeligt med sæbe og vand, hvis en sådan kontakt forekommer; skyl øjnene med rent vand.
English: Blood and immune system
Danish: Blod og immunsystem
English: It is recommended that patients who develop persistent pulmonary symptoms, such as cough and dyspnoea, are investigated.
Danish: Det anbefales at undersøge patienter, som udvikler vedvarende pulmonale symptomer, såsom hoste og dyspnø.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines before you start Myclausen:
Danish: Fortæl især lægen eller apotekspersonalet, hvis du tager noget af nedenstående medicin, før du begynder at tage Myclausen:
English: Patients should be instructed to consult their physician immediately should pregnancy occur.
Danish: Patienterne skal informeres om straks at kontakte deres læge, hvis graviditet opstår.
English: MPA AUC values across age groups were similar in the early and late posttransplant period.
Danish: MPA-AUC-værdier mellem aldersgrupper var sammenlignelige i den tidlige og sene posttransplantationsperiode.
English: • phosphate binders (used by people with chronic kidney failure to reduce how much phosphate gets absorbed into their blood).
Danish: • fosfatbindere (bruges til mennesker med kronisk nyresvigt for at reducere absorptionen af fosfat til blodet).
English: Mycophenolate has been shown to be genotoxic in animal studies at concentrations exceeding the human therapeutic exposures by small margins, such that the risk of genotoxic effects on sperm cells cannot completely be excluded.
Danish: Mycophenolat har vist sig at være genotoksisk i dyrestudier ved koncentrationer, der kun overstiger de menneskelige terapeutiske eksponeringer med små marginer, således at risikoen for genotoksiske virkninger på sædceller ikke helt kan udelukkes.
English: The mechanism for mycophenolate mofetil induced PRCA is unknown.
Danish: Mekanismen for mycophenolatmofetil induceret PRCA er ukendt.
English: Live vaccines should not be given to patients with an impaired immune response.
Danish: Levende vacciner må ikke gives til patienter med nedsat immunforsvar.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, tror, du kan være gravid, eller planlægger at få et barn, skal du spørge lægen eller apotekspersonalet for vejledning, inden du tager denne medicin.
English: Contraceptive requirements for sexually active male patients (including vasectomised men) and female patients of childbearing potential will be explained.
Danish: Kravene til prævention for seksuelt aktive mandlige patienter (herunder vasektomerede mænd) og for fertile kvindelige patienter skal forklares.
English: If you forget to take your medicine at any time, take it as soon as you remember.
Danish: Hvis du på noget tidspunkt glemmer at tage medicinen, skal du tage den, så snart du kommer i tanker om det. Fortsæt derefter med at tage den til de sædvanlige tider.
English: If you stop your treatment you may increase the chance of rejection of your transplanted organ.
Danish: Hvis du stopper behandlingen, kan du øge risikoen for afstødning af det transplanterede organ.
English: • If you have ever had a problem with your digestive system such as a stomach ulcer
Danish: • hvis du har eller nogensinde har haft problemer med fordøjelsessystemet, såsom mavesår
English: AcMPAG is pharmacologically active and is suspected to be responsible for some of mycophenolate mofetil´s side effects (diarrhoea, leucopenia).
Danish: AcMPAG er farmakologisk aktiv og mistænkes for at være ansvarlig for nogle af mycophenolatmofetils bivirkninger (diarré, leukopeni).
English: The change in predose level may not accurately represent changes in overall MPA exposure.
Danish: Ændringen i prædosisniveauet giver ikke nødvendigvis et præcist billede af ændringerne i den samlede MPAeksponering.
English: Telmisartan changes MPA's elimination by enhancing PPAR gamma (peroxisome proliferator-activated receptor gamma) expression, which in turn results in an enhanced UGT1A9 expression and activity.
Danish: Telmisartan ændrer eliminationen af MPA ved at øge ekspressionen af PPAR gamma (peroxisom-proliferator-aktiveret receptor gamma), hvilket resulterer i en øget UGT1A9-ekspression og -aktivitet.
English: The antibody response to other vaccines may be diminished (see also section 4.4).
Danish: Antistofresponset over for andre vacciner kan nedsættes (se også pkt.
English: The information provided in this section will facilitate a correct understanding of the risk and explain the rationale for the following pregnancy prevention measures.
Danish: Informationen i dette afsnit skal sikre en korrekt forståelse for risikoen og forklare formålet forholdsreglerne til at undgå graviditet.
English: • you have a rash, swelling of your face, lips, tongue or throat, with difficulty breathing - you may be having a serious allergic reaction to the medicine (such as anaphylaxis, angioeodema).
Danish: • du får udslæt, opsvulmning af ansigtet, læber, tunge eller hals med åndedrætsbesvær - der kan være tale om en alvorlig allergisk reaktion over for medicinen (såsom anafylaksi, angioødem).
English: The changes in MPAG (the phenolic glucuronide of MPA) pharmacokinetics (MPAG increased by 8 %) were minimal and are not considered clinically significant.
Danish: Ændringerne i MPAGs (MPAs fenoliske glucuronid) farmakokinetik (MPAG steg med 8 %) var minimale og anses ikke for klinisk signifikante.
English: The health professional educational material should contain: · The Summary of Product Characteristics · Guide for healthcare professionals
Danish: Uddannelsesmaterialet for sundhedspersoner skal indeholde: · Produktresumé · En vejledning for sundhedspersoner
English: • pneumonia, bronchitis
Danish: • lungebetændelse, bronkitis
English: Additional adverse reactions reported during post-marketing are described below with the frequencies reported within brackets if known.
Danish: Andre uønskede hændelser, som er indberettet efter markedsføringen beskrives nedenfor, med frekvenserne angivet i parentes, hvis de er kendt.
English: It will explain that although this guide is very important it does not provide full information on mycophenolate mofetil and that the SmPC (healthcare professionals) and package leaflet (patients) supplied with the medicine must also be read carefully.
Danish: Vejledningen skal forklare, at selv om denne vejledning er meget vigtig, så indeholder den ikke al information om mycophenolatmofetil, og at produktresuméet (sundhedspersoner) og indlægssedlen (patienter), som findes i pakningen, skal også læses grundigt.
English: Use in special populations
Danish: Anvendelse hos særlige populationer
English: • gut problems including bleeding, liver problems
Danish: • maveproblemer inklusive blødning, leverproblemer
English: It will provide details about the nature and magnitude of the risk, in line with the information provided in the SmPC.
Danish: Afsnittet skal give detaljer om typen og omfanget af risikoen i overensstemmelse med informationen i produktresuméet.
English: Live vaccines
Danish: Levende vacciner