FrancophonIA/ELRC3.0 huggingface dataset:
English: If neutropenia develops (absolute neutrophil count <°1.3°x 103/°µl) it may be appropriate to interrupt or discontinue Mycophenolate mofetil Teva.
Danish: Hvis der optræder neutropeni (det absolutte neutrofillocyttal < 1,3 x 103/µl), skal behandlingen med Mycophenolate mofetil Teva måske afbrydes eller stoppes.
English: Decreased MPA exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with mycophenolate mofetil.
Danish: Der er observeret nedsat eksponering MPA, når antacida, såsom magnesium-og aluminiumhydroxider, og protonpumpehæmmere, inklusive lansoprazol og pantoprazol, bliver administeret sammen med mycophenolatmofetil.
English: Skin hypertrophy, rash, acne, alopecia
Danish: Hud hypertrofi, udslæt, acne, alopeci
English: Patients receiving Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva, skal informeres om straks at indberette alle tegn på infektion, uventede blodudtrædninger, blødning eller andre manifestationer på knoglemarvsdepression.
English: Mycophenolate mofetil Teva reduces your body's defence mechanism.
Danish: Mycophenolate mofetil Teva nedsætter din organismes forsvarsmekanismer.
English: Treatment with Mycophenolate mofetil Teva should be initiated and maintained by appropriately qualified transplant specialists.
Danish: Behandling med Mycophenolate mofetil Teva bør påbegyndes og fortsættes af specialister med særligt kendskab til transplantationer.
English: Isolated cases of abnormal neutrophil morphology, including the acquired Pelger-Huet anomaly, have been observed in patients treated with mycophenolate mofetil.
Danish: Isolerede tilfælde af abnorm neutrophil morfologi, inklusive den erhvervede Pelger-Huet anomali, er observeret hos patienter, som er behandlet med mycophenolatmofetil.
English: Patients receiving Mycophenolate mofetil Teva should be monitored for neutropenia, which may be related to Mycophenolate mofetil Teva itself, concomitant medicinal products, viral infections, or some combination of these causes.
Danish: Patienter, der får Mycophenolate mofetil Teva, bør monitoreres for neutropeni, som kan relateres til Mycophenolate mofetil Teva, samtidig lægemidler, virale infektioner eller en eller anden kombination af disse årsager.
English: A study of the co-administration of mycophenolate mofetil (1°g BID) and combined oral contraceptives containing ethinylestradiol (0.02°mg to 0.04°mg) and levonorgestrel (0.05°mg to 0.15°mg), desogestrel (0.15°mg) or gestodene (0.05°mg to 0.10°mg) conducted in 18 non-transplant women (not taking other immunosuppressants) over 3 consecutive menstrual cycles showed no clinically relevant influence of mycophenolate mofetil on the ovulation suppressing action of the oral contraceptives.
Danish: Et studie om samtidig administration af mycophenolatmofetil (1 g 2 gange daglig) og orale kontraceptiva af kombinationstypen indeholdende ethinylestradiol (0,02-0,04 mg) og levonorgestrel (0,05-0,15 mg), desogestrel (0,15 mg) eller gestoden (0,05-0,10 mg) hos 18 ikke-transplanterede kvinder (som ikke fik andre immunsupressiva) i 3 konsekutive menstruationscykler viste ingen klinisk relevant påvirkning af mycophenolatmofetil på den ovulationshæmmende virkning af de orale kontraceptiva.
English: Mycophenolate mofetil Teva 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: Mycophenolate mofetil Teva er, i kombination med ciclosporin og kortikosteroider, indiceret til forebyggelse af akut transplantatafstødning hos patienter, der modtager allogene nyre-, hjerte-, eller levertransplantater.
English: Mycophenolate mofetil Teva should not be used at all in children under 2 years old.
Danish: Mycophenolate mofetil Teva bør under ingen omstændigheder anvendes til børn under 2 år.
English: Stopping your treatment with Mycophenolate mofetil Teva may increase the chance of rejection of your transplanted organ.
Danish: Hvis behandlingen med Mycophenolate mofetil Teva stoppes, kan risikoen for afstødning af det transplanterede organ øges.
English: If neutropenia develops, dosing with Mycophenolate mofetil Teva should be interrupted or the dose reduced (see section 4.4).
Danish: Hvis der udvikles neutropeni, skal administrationen af Mycophenolate mofetil Teva afbrydes eller dosis nedsættes (se pkt.
English: Following single dose administration of 1.5°g of mycophenolate mofetil to normal healthy subjects pre-treated with 4°g three times a day (TID) of cholestyramine for 4°days, there was a 40% reduction in the AUC of MPA (see section 4.4 and section 5.2).
Danish: Efter enkeltdosis-administration af 1,5 g mycophenolatmofetil til normale, sunde personer forbehandlet med 4 g colestyramin tre gange daglig i 4 dage var der en 40 % reduktion af MPA-AUC (se pkt.
English: pancreatitis (≥1/100 to <1/10) and intestinal villous atrophy.
Danish: pancreatitis (≥ 1/100 til < 1/10) og intestinal villøs atrofi.
English: • if you are allergic to mycophenolate mofetil, mycophenolic acid or any of the other ingredients of this medicine (listed in section 6).
Danish: - Hvis du er allergisk over for mycophenolatmofetil, mycophenolsyre eller et af de øvrige indholdsstoffer i Mycophenolate mofetil Teva (angivet i punkt 6).
English: Patients on mycophenolate mofetil who develop recurrent infections should have their serum immunoglobulins measured.
Danish: Patienter i behandling med mycophenolatmofetil, der får tilbagevendende infektioner, skal have målt serum-immunglobuliner.
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 (OATP'er) 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: Contact your nearest hospital Accident and Emergency department or a doctor for advice if you have swallowed more tablets than you have been told to take or if you think a child has swallowed any.
Danish: Kontakt det nærmeste hospital, den nærmeste skadestue eller din læge, hvis du har slugt flere tabletter end, du har fået anvist, eller hvis du formoder, at et barn har slugt nogle af tabletterne.
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: The following undesirable effects cover adverse reactions from post-marketing experience The types of adverse reactions reported during post-marketing with mycophenolate mofetil are similar to those seen in the controlled renal, cardiac and hepatic transplant studies.
Danish: Følgende bivirkninger omfatter bivirkninger fra erfaringer efter markedsføring De bivirkninger, som er indberettet om mycophenolatmofetil efter markedsføringen svarer til dem, som er set i de kontrollerede kliniske nyre-, hjerte- og levertransplantationsstudier.
English: Very commonCommon
Danish: Meget almindeligAlmindelig
English: The recommended dose is 600°mg/m2 taken twice a day.
Danish: Den anbefalede dosis er 600 mg/m² to gange daglig.
English: There is no basis for Mycophenolate mofetil Teva dose adjustment following cardiac transplant rejection.
Danish: Der er ikke grundlag for justering af Mycophenolate mofetil Teva-dosis efter afstødning af hjertetransplantat.
English: Mycophenolate mofetil has been shown to be excreted in the milk of lactating rats.
Danish: Det er påvist at mycophenolatmofetil udskilles i mælken hos diegivende rotter.
English: Precautions to be taken before handling or administering the medicinal product Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Mycophenolate mofetil Teva capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in Mycophenolate mofetil Teva capsules.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Da mycophenolatmofetil har udvist teratogen virkning hos rotter og kaniner, må Mycophenolate mofetil Teva kapsler ikke åbnes eller knuses for at undgå inhalation og undgå at hud og slimhinder kommer i direkte kontakt med pulveret i Mycophenolate mofetil Teva kapslerne.
English: Mycophenolate mofetil Teva is used in children and adolescents (aged 2 to 18) to prevent a body rejecting a transplanted kidney.
Danish: Mycophenolate mofetil Teva anvendes til børn og unge (2-18 år) for at forhindre, at deres krop afstøder en transplanteret nyre.
English: Mycophenolate mofetil Teva should not be used in children and adolescents (aged 2 to 18) for heart or liver transplantation.
Danish: Mycophenolate mofetil Teva bør ikke anvendes til børn og unge (2-18 år) i forbindelse med hjerteeller levertransplantation.
English: Agitation, confusional state, depression, anxiety, thinking abnormal, insomnia
Danish: Agitation, konfusion, depression, angst, abnorm tankevirksomhed, insomnia
English: Mycophenolate mofetil Teva has not been shown to impair your ability to drive or operate machines.
Danish: Det er ikke påvist, at Mycophenolate mofetil Teva påvirker evnen til at føre motorkøretøj eller betjene maskiner.
English: Cases of BK virus associated nephropathy, as well as cases of JC virus associated progressive multifocal leucoencephalopathy (PML), have been reported in patients treated with immunosuppressants, including Mycophenolate mofetil Teva.
Danish: Tilfælde af BK-virus associeret med nefropati såvel som tilfælde af JC-virus associeret med progessiv multifokal leukoencefalopati (PML) er blevet rapporteret hos patienter, der behandles med immunsuppressiva herunder Mycophenolate mofetil Teva.
English: Pregnancy, contraception and breast-feeding Contraception in women taking Mycophenolate mofetil Teva
Danish: Graviditet, prævention og amning Prævention hos kvinder, som tager Mycophenolate mofetil Teva
English: Mycophenolate mofetil Teva contains sodium
Danish: Mycophenolate mofetil Teva indeholder natrium
English: Changes to Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva må kun foretages under tilstrækkelig overvågning af den transplanterede patient, så risikoen for afstødning af transplantat minimeres (se pkt.
English: Mycophenolate mofetil Teva is an inosine monophosphate dehydrogenase (IMPDH) inhibitor.
Danish: Mycophenolate mofetil Teva er en inosinmonofosfatdehydrogenase (IMPDH) hæmmer.
English: Precautions to be taken before handling or administering the medicinal product Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Mycophenolate mofetil Teva tablets should not be crushed.
Danish: Sikkerhedsforanstaltninger, der skal tages før håndtering og administration af lægemidlet Da mycophenolatmofetil har udvist teratogen virkning hos rotter og kaniner, må Mycophenolate mofetil Teva tabletter ikke knuses.
English: Patients treated with immunosuppressants, including Mycophenolate mofetil Teva, are at increased risk for opportunistic infections (bacterial, fungal, viral and protozoal), fatal infections and sepsis (see section 4.8).
Danish: Patienter, som bliver behandlet med immunsuppressiva herunder Mycophenolate mofetil Teva, har en øget risiko for opportunistiske infektioner (bakteriel, svampe, viral og protozoel), dødelige infektioner og sepsis (se pkt.
English: Mycophenolate mofetil Teva is a medicine that is used to suppress immune activity.
Danish: Mycophenolate mofetil Teva er medicin, der anvendes til at nedsætte immunforsvaret.
English: In patients with renal impairment in whom mycophenolate mofetil and ganciclovir or its prodrugs, e.g. valganciclovir, are co-administered the dose recommendations for ganciclovir should be observed and patients monitored carefully.
Danish: Hos patienter med nedsat nyrefunktion, som får Mycophenolate mofetil Teva og ganciclovir, eller deres prodrugs, f.eks. valganciclovir, samtidig bør dosisanbefalingerne for ganciclovir følges og patienterne monitoreres omhyggeligt.
English: • For 6°weeks after you stop taking Mycophenolate mofetil Teva.
Danish: • I 6 uger efter du er stoppet med at tage Mycophenolate mofetil Teva.
English: These are insufficient to make dose recommendations and therefore use in this age group is not recommended.
Danish: De er ikke tilstrækkelige til af komme med dosisrekommendationer, og det anbefales derfor ikke at anvende Mycophenolate mofetil Teva til denne aldersgruppe.
English: PRCA may resolve with dose reduction or cessation of Mycophenolate mofetil Teva therapy.
Danish: PRCA kan forsvinde ved reduktion af dosis eller ved ophør af Mycophenolate mofetil Teva-behandling.
English: Do not stop taking Mycophenolate mofetil Teva because you feel better.
Danish: Stop ikke med at tage Mycophenolate mofetil Teva, bare fordi du måtte få det bedre.
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 filtration < 25 ml/min1,73 m2), bortset fra perioden umiddelbart efter transplantionen, bør doser på mere end 1 g administreret to gange dagligt undgås.
English: The MAH shall ensure that in each MS where Mycophenolate mofetil Teva is marketed, all healthcare professionals and patients who are expected to prescribe, dispense or use Mycophenolate mofetil Teva are provided with the following educational package:
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alt sundhedspersonale og patienter, som forventes at udskrive, udlevere eller anvende Mycophenolate mofetil Teva, i alle medlemslande, hvor Mycophenolate mofetil Teva markedsføres, har fået følgende uddannelsespakker:
English: Because T- and B-lymphocytes are critically dependent for their proliferation on de novo synthesis of purines whereas other cell types can utilise salvage pathways, MPA has more potent cytostatic effects on lymphocytes than on other cells.
Danish: Da T- og Blymfocytter i deres proliferation, i modsætning til andre celletyper, der kan anvende alternative veje, er helt afhængige af en de novo-syntese af puriner, har MPA en mere potent cytostatisk virkning på lymfocytter end på andre celler.
English: Because of the potential for serious adverse reactions to mycophenolate mofetil in breast-fed infants, Mycophenolate mofetil Teva is contraindicated in breast-feeding mothers (see section 4.3).
Danish: På grund af risikoen for alvorlige bivirkninger af mycophenolatmofetil hos ammende spædbørn, er Mycophenolate mofetil Teva kontraindiceret hos ammende mødre (se pkt.
English: Mycophenolate mofetil Teva capsules should be handled with care.
Danish: Mycophenolate mofetil Teva kapsler skal håndteres forsigtigt.
English: Talk to your doctor or pharmacist before taking Mycophenolate mofetil Teva.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Mycophenolat mofetil Teva.
English: The recommended dose of 1°g administered twice a day for renal transplant patients and 1.5°g twice a day for cardiac or hepatic transplant patients is appropriate for the elderly.
Danish: Den anbefalede dosering på 1 g administreret to gange daglig til nyretransplantationspatienter og 1,5 g administreret to gange daglig til hjerte- eller levertransplanterede patienter er passende til ældre.
English: Pharmacokinetic parameters were evaluated in 49 paediatric renal transplant patients (aged 2 to 18°years) given 600°mg/m2 mycophenolate mofetil orally twice daily.
Danish: Farmakokinetiske parametre evalueredes hos 49 nyretransplanterede børn (2-18 år), som fik 600 mg/m2 mycophenolatmofetil oralt to gange daglig.
English: If you are a woman who could become pregnant you must use an effective method of contraception with Mycophenolate mofetil Teva.
Danish: Hvis du er en kvinde og kan blive gravid, skal du bruge en effektiv præventionsmetode, mens du tager Mycophenolate mofetil Teva, herunder:
English: Mycophenolate mofetil has been associated with an increased incidence of digestive system adverse events, including infrequent cases of gastrointestinal tract ulceration, haemorrhage and perforation.
Danish: Mycophenolatmofetil er blevet sat i forbindelse med en øget incidens af bivirkninger i fordøjelsessystemet inklusive sjældne tilfælde af ulceration, blødning og perforation.
English: Oral Mycophenolate mofetil Teva should be initiated within 72°hours following transplantation.
Danish: Oralt Mycophenolate mofetil Teva bør gives indenfor 72 timer efter transplantation.
English: The first dose of oral Mycophenolate mofetil Teva 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 Mycophenolate mofetil Teva til indtagelse gennem munden gives tidligst 4 dage efter transplantationen, og når du er i stand til at indtage medicin gennem munden.
English: • if you are planning to become pregnant, or if you get pregnant while taking Mycophenolate mofetil
Danish: - Hvis du planlægger at blive gravid, eller hvis du bliver gravid, mens du tager Mycophenolate mofetil Teva.
English: No substantial alteration of MPA pharmacokinetics is anticipated and mycophenolate mofetil dose adjustment is not required.
Danish: Der forudses ingen væsentlig ændring af MPA's farmakokinetik og dosisjustering af mycophenolatmofetil er ikke nødvendig.
English: Mycophenolate mofetil Teva film-coated tablets should be handled with care.
Danish: Mycophenolate mofetil Teva filmovertrukne tabletter skal håndteres med forsigtighed.
English: In contrast, if concomitant ciclosporin treatment is stopped, an increase in MPA AUC of around 30% should be expected.
Danish: Derimod må en stigning i MPAs AUC på ca. 30 % forventes, hvis samtidig ciclosporinbehandling seponeres.
English: Female patients of reproductive potential must be made aware of the increased risk of pregnancy loss and congenital malformations at the beginning of the treatment and must be counselled regarding pregnancy prevention and planning.
Danish: Når behandlingen initieres, skal kvinder i den fertile alder informeres om den øgede risiko for abort og medfødte misdannelser, og de skal vejledes omkring prævention og graviditetsplanlægning.
English: The following undesirable effects cover adverse reactions from clinical trials The principal adverse reactions associated with the administration of mycophenolate mofetil in combination with ciclosporin and corticosteroids include diarrhoea, leucopenia, sepsis and vomiting and there is evidence of a higher frequency of certain types of infections (see section 4.4).
Danish: Følgende bivirkninger omfatter bivirkninger fra de kliniske studier De vigtigste bivirkninger i forbindelse med administrationen af mycophenolatmofetil i kombination med ciclosporin og kortikosteroider omfatter diarré, leukopeni, sepsis og opkastning, og der er tegn på større hyppighed af visse typer infektioner (se pkt.
English: In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of mycophenolate mofetil (1.5°g taken twice a day [BID], morning and evening) were administered to hepatic transplant patients taking tacrolimus.
Danish: I modsætning hertil blev AUC for tacrolimus øget med ca. 20 %, når flere mycophenolatmofetil-doser (1,5 g to gange daglig, morgen og aften) blev givet til levertransplanterede patienter, som fik tacrolimus.
English: • During your entire treatment with Mycophenolate mofetil Teva
Danish: • Under hele behandlingen med Mycophenolate mofetil Teva
English: Hypersensitivity reactions to Mycophenolate mofetil Teva have been observed (see section 4.8).
Danish: Der er observeret overfølsomhedsreaktioner over for Mycophenolate mofetil Teva (se pkt.
English: • proliferation of the lymphatic tissue, including malignant tumours
Danish: • spredning af lymfevæv, herunder kræftsvulster
English: It is recommended to monitor MPA exposure levels and to adjust Mycophenolate mofetil Teva doses accordingly to maintain clinical efficacy when rifampicin is administered concomitantly.
Danish: For at opretholde den kliniske effekt bør MPA-eksponeringen overvåges, og Mycophenolate mofetil Teva-doserne justeres i forhold til dette, når rifampicin administreres samtidigt.
English: Paediatric population aged 2 to 18 years The recommended dose of mycophenolate mofetil is 600 mg/m2 administered orally twice daily (up to a maximum of 2 g daily).
Danish: Pædiatrisk population 2-18 år Den anbefalede dosis af mycophenolatmofetil er 600 mg/m2 oralt to gange daglig (højst 2 g daglig).
English: As some adverse reactions occur with greater frequency in this age group (see section 4.8) compared with adults, temporary dose reduction or interruption may be required; these will need to take into account relevant clinical factors including severity of reaction.
Danish: 4.8) end hos voksne, kan det blive nødvendigt forbigående at nedsætte dosis eller afbryde behandlingen, under behørig hensyntagen til relevante kliniske faktorer, inklusive bivirkningssværhedsgraden.
English: Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
Danish: Gastrointestinal blødning, peritonitis, ileus, colitis, mavesår, ulcus duodeni, gastritis, oesophagitis, stomatitis, obstipation, dyspepsi, flatulens, opstød
English: values similar to those seen in adult renal transplant patients receiving mycophenolate mofetil 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 mycophenolatmofetil 1 g to gange daglig i den tidlige og sene posttransplantationsperiode.
English: • skin cancer, non-cancerous growth of the skin
Danish: • hudkræft eller godartede vækster på huden
English: Mycophenolate mofetil Teva 500 mg film-coated tablets are available in PVC/PVdC-aluminium blisters in pack sizes of 50 or 150 or 50 x 1 tablets per carton.
Danish: Mycophenolate mofetil Teva 500 mg filmovertrukket tabletter fås i PVC/PVdC-aluminium blistre i pakningstørrelser på 50 og 150 eller 50x1 tabletter pr. karton.
English: Adverse reactions, probably or possibly related to mycophenolate mofetil, reported in ≥1/10 and in ≥1/100 to <1/10 of patients treated with mycophenolate mofetil in the controlled clinical trials of renal (2°g data), cardiac and hepatic transplant patients are listed in the following table.
Danish: Bivirkninger, som var ”sandsynligt relateret” eller ”muligt relateret” til mycophenolatmofetil, og som rapporteredes hos ≥ 1/10 og hos ≥ 1/100 til < 1/10 af de patienter, der blev behandlet med mycophenolatmofetil i de kontrollerede kliniske studier med nyre- (2 g data), hjerte- og levertransplanterede patienter er anført i den følgende tabel.
English: • Before you start taking Mycophenolate mofetil Teva
Danish: • Før du starter med at tage Mycophenolate mofetil Teva
English: Therefore Mycophenolate mofetil Teva is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection.
Danish: Derfor er Mycophenolate mofetil Teva kontraindiceret under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet.