natgillin/translations-raw huggingface dataset:
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.
Following single dose administration of 1.5 g of mycophenolate mofetil to normal healthy subjects pre-treated with 4 g TID of cholestyramine for 4 days, there was a 40 % reduction in the AUC of MPA (see section 4.4 and section 5.2).
Myclausen 500 mg filmovertrukne tabletter leveres i PVC-aluminium blisterkort indeholdende 10 tabletter.
Myclausen 500 mg film-coated tablets are available in PVC-aluminium blisters containing 10 tablets.
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Passauer Pharma GmbH
NAME OF THE MARKETING AUTHORISATION HOLDER Passauer Pharma GmbH
• Tag 2 tabletter om morgenen og 2 tabletter om aftenen.
• Take 2 tablets in the morning then 2 tablets in the evening.
I en enkelt-dosis undersøgelse (6 personer per gruppe) blev middelværdi for plasma MPA-AUC hos personer med svær, kronisk nedsat nyrefunktion (glomerulær filtrationsrate < 25 ml/min/1,73 m observeret til 28-75 % højere i forhold til middelværdierne hos normale, sunde personer eller personer med let nedsat nyrefunktion.
In a single dose study (6 subjects/group), mean plasma MPA AUC observed in subjects with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 m2) were 28-75 % higher relative to the means observed in normal healthy subjects or subjects with lesser degrees of renal impairment.
Myclausen indeholder mycophenolatmofetil.
Myclausen contains mycophenolate mofetil.
• De må ikke brækkes over eller knuses.
They should not be opened or crushed.
Det skal du vide, før du begynder at tage Myclausen
What you need to know before you take Myclausen
Efter en gennemgang af tilgængelig information om graviditet, efter faderen er blevet eksponeret for mycophenolatmofetil eller mycophenolsyre, herunder en gennemgang af alle ikke-kliniske data og information om overførsel af mycophenolsyre via sæden, konkluderede PRAC, at data ikke viser nogen mønstre eller en stigning i medfødte misdannelser eller spontane aborter.
Taking into account the PRAC Assessment Report on the PSUR(s) for mycophenolate mofetil, mycophenolic acid, the scientific conclusions of CHMP are as follows: Following a review of all available information regarding pregnancies following paternal exposure to mycophenolate mofetil or mycophenolic acid, including a review of all nonclinical data and information on transmission of mycophenolic acid via the semen, the PRAC concluded that the data does not highlight any patterns or an increase in congenital malformations or spontaneous abortions.
Derimod må en stigning i MPAs AUC på ca. 30 % forventes, hvis samtidig ciclosporinbehandling seponeres.
In contrast, if concomitant ciclosporin treatment is stopped, an increase in MPA AUC of around 30 % should be expected.
Ældre patienter, som får mycophenolatmofetil som led i et immunsuppressivt kombinationsregime, kan have større risiko for visse infektioner (inklusive vævsinvasiv sygdom forårsaget af cytomegalovirus) og muligvis gastrointestinal blødning og lungeødem sammenlignet med yngre individer.
Elderly patients receiving mycophenolate mofetil 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.
Hvide, runde, filmovertrukne tabletter.
White round film-coated tablets.
Meget almindelig Almindelig Forhøjede leverenzymer, forhøjet serum-creatinin, forhøjet laktatdehydrogenase, forhøjet serum-carbamid, forhøjede basiske fosfataser, vægttab Note: 501 (2 g mycophenolatmofetil daglig), 289 (3 g mycophenolatmofetil dagligt) og 277 (2 g intravenøst/ 3 g oral mycophenolatmofetil dagligt) patienter i fase III studier blev behandlet med henblik på forebyggelse af afstødelse efter henholdsvis nyre-, hjerte- og levertransplantation.
Very common Common Hepatic enzyme increased, blood creatinine increased, blood lactate dehydrogenase increased, blood urea increased, blood alkaline phosphatase increased, weight decreased Note: 501 (2 g mycophenolate mofetil daily), 289 (3 g mycophenolate mofetil daily) and 277 (2 g intravenous / 3 g oral mycophenolate mofetil daily) patients were treated in Phase III studies for the prevention of rejection in renal, cardiac and hepatic transplantation, respectively.
Meget almindelig Almindelig Acidose, hyperkaliæmi, hypokaliæmi, hyperglykæmi, hypomagnesæmi, hypokalcæmi, hyperkolesterolæmi, hyperlipæmi, hypofosfatæmi, hyperurikæmi, arthritis urica, anoreksi
Very common Common Acidosis, hyperkalaemia, hypokalaemia, hyperglycaemia, hypomagnesaemia, hypocalcaemia, hypercholesterolaemia, hyperlipidaemia, hypophosphataemia, hyperuricaemia, gout, anorexia
• Introduktionen til vejledningerne skal informere læseren om, at formålet med vejledningen er at informere om, at føtal eksponering skal undgås.
• An introduction in each guide will inform the reader that the purpose of the guide is to tell them that a foetal exposure must be avoided and how to minimize the risk of birth defects and miscarriage associated with mycophenolate mofetil.
Tag altid lægemidlet nøjagtigt efter lægens anvisning.
Always take Myclausen exactly as your doctor has told you.
Der har været indberetninger om aplastisk anæmi og knoglemarvsdepression hos patienter behandlet med mycophenolatmofetil, hvor nogle har været fatale.
There have been reports of aplastic anaemia and bone marrow depression in patients treated with mycophenolate mofetil, some of which have been fatal.
Sammenlignet med data efter 1 år viste sikkerhedsdata for 3 år ingen uventede ændringer mht. hyppighed af malignitet hos nyre- og hjertetransplanterede patienter.
Three-year safety data in renal and cardiac transplant patients did not reveal any unexpected changes in incidence of malignancy compared to the 1-year data.
Administration Oral administration
Method of administration
Andre lidelser såsom: • vægttab, urinsyregigt, forhøjet blodsukker, blødning, blå mærker.
Other problems such as: • weight loss, gout, high blood sugar, bleeding, bruising.
Pædiatrisk population Der er ingen tilgængelige data vedrørende levertransplantationer hos pædiatriske patienter.
Paediatric population No data are available for paediatric hepatic transplant patients.
Risiko/-fordel forholdet ved anvendelse af mycophenolatmofetil i kombination med tacrolimus eller sirolimus er ikke blevet klarlagt (se også pkt.
The risk/benefit ratio of mycophenolate mofetil in combination with tacrolimus or sirolimus has not been established (see also section 4.5).
I et klinisk studie, som rekrutterede 92 børn i alderen 2-18 år, og som fik 600 mg/m mycophenolatmofetil oralt to gange daglig, var typen og hyppigheden af uønskede hændelser generelt den samme som dem, der observeredes hos voksne patienter, som fik 1 g mycophenolatmofetil to gange dagligt.
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/m mycophenolate mofetil orally twice daily, were generally similar to those observed in adult patients given 1 g mycophenolate mofetil twice daily.
Da mycophenolatmofetil har udvist teratogen virkning hos rotter og kaniner, må Myclausen kapsler ikke åbnes eller knuses.
Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myclausen film-coated tablets should not be broken or crushed.
Tablet-overtræk polyvinylalkohol (delvist hydrolyseret) titandioxid (E 171) macrogol 3000 talkum
Polyvinyl alcohol (partially hydrolysed) Titanium dioxide (E 171) Macrogol 3000
Du må ikke give blod under behandling med Myclausen og i mindst 6 uger efter behandlingens ophør.
You must not donate blood during treatment with Myclausen and for at least 6 weeks after stopping treatment.
• hvis du uden grund får blå mærker eller bløder
• If you have any unexpected bruising or bleeding
Uønskede hændelser, der rapporteredes hos patienter, som blev behandlet med mycophenolatmofetil i kombination med ciclosporin og kortikosteroider i de kliniske nyre-, hjerte- og leverstudier
Adverse reactions, reported in patients treated with mycophenolate mofetil in renal, cardiac and hepatic clinical trials when used in combination with ciclosporin and corticosteroids
Medfødte misdannelser, som har været rapporteret, inkluderer abnormiteter i ører, øjne og ansigt (læbe-gane spalte) eller i fingrenes udvikling, samt i hjerte, spiserør, nyrer og nervesystem (f.eks. manglende sammenvoksning af ryggraden (spina bifida).
Birth defects which have been reported include anomalies of ears, of eyes, of face (cleft lip/palate), of development of fingers, of heart, oesophagus (tube that connects the throat with the stomach), kidneys and nervous system (for example spina bifida (where the bones of the spine are not properly developed)).Your baby may be affected by one or more of these.
Hvide, aflange kapsler.
White oblong capsules.
Mænd må ikke være sæddonorer under behandling med Myclausen og i mindst 90 dage efter behandlingens ophør.
Men must not donate semen during treatment with Myclausen and for at least 90 days after stopping treatment.
Der findes ingen farmakokinetiske data for afstødning af levertransplantat.
No pharmacokinetic data are available during hepatic transplant rejection.
• Tag 3 tabletter om morgenen og 3 tabletter om aftenen.
• Take 3 tablets in the morning and then 3 tablets in the evening.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 50 filmovertrukne tabletter
PHARMACEUTICAL FORM AND CONTENTS 50 film-coated tablets
• abnormiteter i ørerne (f.eks. abnormt formet eller manglende ydre øre), tillukning af øregangen
• Abnormalities of the ear (e.g. abnormally formed or absent external ear), external auditory canal artesia (middle ear);
Meget almindelig Almindelig Hud hypertrofi, udslæt, acne, alopeci
Common Skin hypertrophy, rash, acne, alopecia
Ældre patienter kan have større risiko for bivirkninger, såsom visse infektioner (inklusiv vævsinvasiv sygdom forårsaget af cytomegalovirus) og muligvis gastrointestinal blødning og lungeødem, sammenlignet med yngre patienter (se pkt.
Elderly patients may be at an increased risk of adverse events such as certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared with younger individuals (see section 4.8).
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 150 filmovertrukne tabletter
PHARMACEUTICAL FORM AND CONTENTS 150 film-coated tablets
Hos nyretransplanterede patienter blev tacrolimuskoncentrationen imidlertid tilsyneladende ikke påvirket af mycophenolatmofetil (se også pkt.
However, in renal transplant patients, tacrolimus concentration did not appear to be altered by mycophenolate mofetil (see also section 4.4).
Urinvejslidelser såsom: • nyreproblemer eller akut vandladningstrang.
Urinary problems such as: • kidney problems or the urgent need to pass water (urine).
Anvendelse i forbindelse med hjertetransplantation
Use in cardiac transplant
GENEREL KLASSIFIKATION FOR UDLEVERING Receptpligtigt lægemiddel
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Medicinens fulde navn er Myclausen 250 mg hårde kapsler.
The full name of your medicine is Myclausen 250 mg hard capsules.
Galdesyrebindende stoffer, som colestyramin, kan fjerne MPA ved at nedsætte den enterohepatiske recirkulation af stoffet (se pkt.
Bile acid sequestrants, such as cholestyramine, can remove MPA by decreasing the enterohepatic recirculation of the drug (see section 5.2).
Tilfælde af pure red cell aplasia (PRCA) er blevet rapporteret hos patienter i behandling med mycophenolatmofetil i kombination med andre immunosuppressiva.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil in combination with other immunosuppressants.
MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/647/003 (100 hårde kapsler)
MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/003 (100 hard capsules)
• Vejledning om, at patienter ikke må være bloddonorer under behandlingen og i mindst 6 uger efter, at mycophenolat er seponeret .
• Advice that patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
På baggrund af de videnskabelige konklusioner for mycophenolatmofetil, mycophenolsyre er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder mycophenolatmofetil, mycophenolsyre, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for mycophenolate mofetil, mycophenolic acid the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing mycophenolate mofetil, mycophenolic acid is unchanged subject to the proposed changes to the product information
Indehaver af markedsføringstilladelsen Passauer Pharma GmbH Eiderstedter Weg 3
Marketing Authorisation Holder Passauer Pharma GmbH Eiderstedter Weg 3
• forstoppelse, kvalme, fordøjelsesbesvær, appetitløshed, luft i maven.
• constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.
Tilfælde af pure red cell aplasia (PRCA) er rapporteret hos patienter, behandlet med mycophenolatmofetil (se pkt.
Cases of pure red cell aplasia (PRCA) have been reported in patients treated with mycophenolate mofetil (see section 4.4).
• betændelse i bugspytkirtlen, tarmen eller maven
• inflammation of the pancreas, colon or stomach
Meget almindelig Almindelig Takykardi
Common Tachycardia
• du uden grund får blå mærker eller bløder
• you have any unexpected bruising or bleeding
Meget almindelig Almindelig Pleural effusion, dyspnø, hoste
Common Pleural effusion, dyspnoea, cough
Afstødning af nyretransplantat medfører ingen ændringer af MPA's farmakokinetik; dosisreduktion eller afbrydelse af Myclausen er ikke nødvendig.
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 Myclausen is not required.
Kapselskal gelatine titandioxid (E 171)
Capsule shells: gelatine, titanium dioxide (E 171)
4.8) end hos voksne, kan det blive nødvendigt forbigående at nedsætte dosis eller afbryde behandlingen, under behørig hensyntagen til relevante kliniske faktorer, inklusive bivirkningernes sværhedsgrad.
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.
Efter markedsføring er der observeret medfødte misdannelser, herunder rapporter om multiple misdannelser hos børn af patienter, som under graviditeten var blevet behandlet med Myclausen i kombination med andre immunsuppressiva.
Congenital malformations, including reports of multiple malformations, have been observed postmarketing in children of patients exposed to Myclausen in combination with other immunosuppressants during pregnancy.
• Du må ikke knuse eller brække kapslerne over
Do not break or crush the tablets.
• Myclausen må ikke anvendes under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling til at forhindre afstødning af transplantatet (se pkt.
• Myclausen should not be used in pregnancy unless there is no suitable alternative treatment to prevent transplant rejection (see section 4.6).
Graviditet, prævention og amning
Pregnancy, contraception and breast-feeding
Hos nyretransplanterede patienter er der i dagene umiddelbart efter start af behandling med oral ciprofloxacin eller amoxicillin plus clavulansyre rapporteret om en reduktion i præ-dosis- MPA (trough) koncentrationerne på ca. 50 %.
Ciprofloxacin and amoxicillin plus clavulanic acid Reductions in pre-dose (trough) MPA concentrations of about 50 % have been reported in renal transplant recipients in the days immediately following commencement of oral ciprofloxacin or amoxicillin plus clavulanic acid.
Almindelig Pneumoni, influenza, infektion i luftrøret, respiratorisk moniliasis, gastrointestinal infektion, candidiasis, gastroenteritis, infektion, bronkitis, pharyngitis, sinuitis, svampeinfektion i huden, hud candidiasis, vaginal candidiasis, rhinitis
Sepsis, gastrointestinal candidiasis, urinary tract infection, herpes simplex, herpes zoster Common Pneumonia, influenza, respiratory tract infection, respiratory moniliasis, gastrointestinal infection, candidiasis, gastroenteritis, infection, bronchitis, pharyngitis, sinusitis, fungal skin infection, skin candida, vaginal candidiasis, rhinitis
Hypogammaglobulinæmi er rapporteret hos patienter, der har fået mycophenolatmofetil i kombination med andre immunsuppressiva (hyppighed ukendt).
Hypogammaglobulinaemia has been reported in patients receiving mycophenolate mofetil in combination with other immunosuppressants (frequency not known).
• trakeo-øsofageale misdannelser (f.eks. øsofagusatresi);
• Tracheo-Oesophageal malformations (e.g. oesophageal atresia);
• Myclausen må ikke anvendes hos fertile kvinder, som ikke anvender højeffektiv prævention (se ptk.
• Myclausen should not be given to women of childbearing potential who are not using highly effective contraception (see section 4.6).
• Myclausen-behandling må ikke initieres hos fertile kvinder uden at en negativ graviditetstest foreligger, for at udelukke en uønsket anvendelse under graviditet (se pkt.
• Myclausen 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).
Medicinens fulde navn er Myclausen 500 mg filmovertrukne tabletter.
The full name of your medicine is Myclausen 500 mg film-coated tablets.
Farmakokinetikken og farmakodynamikken af orale antikonceptionsmidler påvirkedes ikke af samtidig administration af mycophenolatmofetil (se også pkt.
The pharmacokinetics and pharmacodynamics of oral contraceptives were unaffected by coadministration of mycophenolate mofetil (see also section 5.2).
Når behandlingen initieres, skal fertile kvinder informeres om den øgede risiko for abort og medfødte misdannelser, og de skal vejledes omkring prævention og graviditetsplanlægning.
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.
Disse infektioner er ofte forbundet med en høj samlet immunosuppressiv belastning og kan forårsage alvorlige eller fatale sygdomme.
These infections are often related to a high total immunosuppressive burden and may lead to serious or fatal conditions that physicians should consider in the differential diagnosis in immunosuppressed patients with deteriorating renal function or neurological symptoms.
Patienter med en legemsoverflade over 1,5 m² kan ordineres Myclausen kapsler i en dosis på 1 g to gange daglig (daglig dosis: 2 g).
Patients with a body surface area greater than 1.5 m may be prescribed Myclausen capsules at a dose of 1 g twice daily (2 g daily dose).
• syreneutraliserende midler eller protonpumpehæmmere (bruges mod for meget mavesyre, f.eks.
• antacids or proton pump inhibitors (used for acid problems in your stomach such as indigestion)
Patienter må ikke donere blod under behandlingen og i mindst 6 uger efter seponering af mycophenolat.
Patients should not donate blood during therapy or for at least 6 weeks following discontinuation of mycophenolate.
LÆGEMIDLETS NAVN Myclausen 250 mg hårde kapsler
NAME OF THE MEDICINAL PRODUCT Myclausen 250 mg hard capsules
Myclausen filmovertrukne 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).
Myclausen film-coated 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).
Hjertetransplantation
Heart transplant
Dosisjustering er ikke nødvendig hos nyretransplanterede patienter med svær leverparenkymlidelse.
No dose adjustments are needed for renal transplant patients with severe hepatic parenchymal disease.
Der er publicerede tilfælde af bronkiektasi hos voksne og børn, der har fået Mycophenolatmofetil i kombination med andre immunsuppressiva.
There have been published reports of bronchiectasis in adults and children who received mycophenolate mofetil in combination with other immunosuppressants.
• misdannelser i nervesystemet såsom rygmarvsbrok;
• Nervous system malformations such as spina bifida;
• hvis du ikke anvender effektiv prævention (se ”Graviditet, prævention og amning”)
• If you are pregnant or planning to become pregnant or think you may be pregnant If you are not using effective contraception (see Pregnancy, contraception and breast-feeding).
Patienter, der får immunosuppressiv behandling med kombinationer af lægemidler, inklusive mycophenolatmofetil, har forøget risiko for at udvikle lymfomer og andre maligne lidelser, især i huden (se pkt.
Patients receiving immunosuppressive regimens involving combinations of medicinal products, including mycophenolate mofetil, are at increased risk of developing lymphomas and other malignancies, particularly of the skin (see section 4.4).
Gelatine, titandioxid (E 171)
Titanium dioxide (E 171)
Den i dyre carcinogenicitetsundersøgelser højest testede dosis resulterede i ca. 2 - 3 gange den systemiske eksponering (AUC eller Cmax), der er observeret hos nyretransplanterede patienter, der fik den anbefalede kliniske dosis på 2 g daglig og 1,3 - 2 gange den systemiske eksponering (AUC eller Cmax) observeret hos hjertetransplanterede patienter, der fik den anbefalede kliniske dosis på 3 g daglig.
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.
• Tag 6 kapsler om morgenen og 6 kapsler om aftenen.
• Take 6 capsules in the morning and then 6 capsules in the evening.
Sådan et blodbillede kan fejlagtigt blive tolket som et tegn på infektion hos immunsupprimerede patienter, som dem der behandles med mycophenolatmofetil.
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.
• hvis du ammer.
If you are breast-feeding.
Opkastning, abdominalsmerter, diarré, kvalme Almindelig Gastrointestinal blødning, peritonitis, ileus, colitis, mavesår, ulcus duodeni, gastritis, oesophagitis, stomatitis, obstipation, dyspepsi, flatulens, opstød
Common Gastrointestinal haemorrhage, peritonitis, ileus, colitis, gastric ulcer, duodenal ulcer, gastritis, oesophagitis, stomatitis, constipation, dyspepsia, flatulence, eructation
Farmakokinetikken af orale kontraceptiva påvirkedes ikke af samtidig administration af mycophenolatmofetil (se også pkt.
The pharmacokinetics of oral contraceptives were unaffected by coadministration of mycophenolate mofetil (see also section 4.5).
I kontrollerede kliniske studier hos nyre- (2 g data), hjerte- og levertransplanterede patienter, 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, CMV-viræmi/syndrom og herpes simplex-infektioner.
The most common opportunistic infections in patients receiving mycophenolate mofetil (2 g or 3 g daily) with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year were candida mucocutaneous, CMV viraemia/syndrome and Herpes simplex.