FrancophonIA/ELRC3.0 huggingface dataset:
English: Congenital malformations have been observed post-marketing in children of patients exposed to mycophenolate mofetil in combination with other immunosuppressants, see section 4.6.
Danish: Efter markedsføring er der blevet observeret medfødte misdannelser hos børn af patienter, der har været eksponeret for Myclausen i kombination med andre immunsuppressiva, se pkt.
English: Tablet core: Microcrystalline cellulose, povidone (K-30), croscarmellose sodium, magnesium stearate
Danish: Mikrokrystallinsk cellulose, povidon (K-30), croscarmellosenatrium, magnesiumstearat
English: The active substance is mycophenolate mofetil. Each tablet contains 500 mg mycophenolate mofetil
Danish: Aktivt stof: mycophenolatmofetil Hver tablet indeholder 500 mg mycophenolatmofetil Øvrige indholdsstoffer:
English: The systemic exposure at this dose was approximately 0.5 times the clinical exposure at the recommended clinical dose of 2 g/day for renal transplant patients and approximately 0.3 times the clinical exposure at the recommended clinical dose of 3 g/day for cardiac transplant patients.
Danish: Den systemiske eksponering af denne dosis var ca. 0,5 gange den kliniske eksponering af den anbefalede kliniske dosis på 2 g daglig til nyretransplanterede patienter og ca. 0,3 gange den kliniske eksponering ved den anbefalede kliniske dosis på 3 g daglig til hjertetransplanterede patienter.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/001-002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/647/001-002
English: PHARMACEUTICAL FORM Film-coated tablet White round film-coated tablets.
Danish: LÆGEMIDDELFORM Filmovertrukken tablet.
English: In order to assist patients in avoiding foetal exposure to mycophenolate and to provide additional important safety information, the Marketing Authorisation holder will provide educational materials to healthcare professionals.
Danish: Indehaveren af markedføringstilladelsen vil sikre uddannelsesmateriale til sundhedspersonale, for at hjælpe patienter med at undgå føtal eksponering af mycophenolat og for at fremskaffe yderligere vigtig sikkerhedsinformation.
English: NAME OF THE MEDICINAL PRODUCT Myclausen 500 mg film-coated tablets Mycophenolate mofetil
Danish: LÆGEMIDLETS NAVN Myclausen 500 mg filmovertrukne tabletter Mycophenolatmofetil
English: - This medicine has been prescribed for you only.
Danish: - Lægen har ordineret Myclausen til dig personligt.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 500 mg mycophenolate mofetil.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 500 mg mycophenolatmofetil.
English: • The daily dose is 8 capsules (2 g of the medicine) taken as 2 separate doses.
Danish: • Den daglige dosis er 8 kapsler (2 g af medicinen) indtaget som 2 separate doser.
English: In some of these cases switching mycophenolate mofetil to another immunosuppressant resulted in improvement in respiratory symptoms.
Danish: I nogle af disse tilfælde sås forbedringer i de respiratoriske symptomer, når Mycophenolatmofetil blev erstattet af alternative immunsuppressiva.
English: How to take Myclausen
Danish: Sådan skal du tage Myclausen
English: How to store Myclausen
Danish: Indtagelse af Myclausen
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 250 mg mycophenolate mofetil.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 250 mg mycophenolatmofetil.
English: However, keep taking Myclausen until you see him or her.
Danish: Fortsæt dog behandlingen, indtil du ser lægen.
English: Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myclausen capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in Myclausen capsules.
Danish: Undgå inhalation og undgå at hud og slimhinder kommer i direkte kontakt med pulveret i Myclausen kapslerne.
English: Take care not to let any powder from inside a broken capsule get into your eyes or mouth • If this happens, rinse with plenty of water.
Danish: Undgå pulver fra itugåede kapsler kommer i kontakt med dine øjne eller mund.
English: No data are available for paediatric cardiac transplant patients.
Danish: Pædiatrisk population Der er ingen tilgængelige data vedrørende hjertetransplantationer hos pædiatriske patienter.
English: • The daily dose is 4 tablets (2 g of the medicine) taken as 2 separate doses.
Danish: • Den daglige dosis er 4 tabletter (2 g af medicinen) indtaget som 2 separate doser.
English: Men should not donate semen during therapy or for 90 days following discontinuation of mycophenolate.
Danish: Mænd må ikke være sæddonorer under behandlingen og i mindst 90 dage efter seponering af mycophenolat.
English: The recommended oral dose in hepatic transplant patients is 1.5 g administered twice daily (3 g daily dose).
Danish: Den anbefalede orale Myclausen dosis til levertransplanterede patienter er 1,5 g to gange daglig (daglig dosis: 3 g).
English: Lymphoproliferative disease or lymphoma developed in 0.6 % of patients receiving mycophenolate mofetil (2 g or 3 g daily) in combination with other immunosuppressants in controlled clinical trials of renal (2 g data), cardiac and hepatic transplant patients followed for at least 1 year.
Danish: I kontrollerede kliniske studier hos nyre- (2 g data), hjerte- og levertransplanterede patienter, som kontrolleredes i mindst 1 år, udvikledes lymfoproliferativ sygdom eller lymfomer hos 0,6 % af de patienter som fik mycophenolatmofetil (2 eller 3 g daglig) sammen med andre immunsuppressive stoffer.
English: Contraception in women taking Myclausen If you are a woman who could become pregnant you must use an effective methods of contraception with Myclausen.
Danish: Hvis du er kvinde og kan blive gravid, skal du bruge en effektiv præventionsmetode, mens du tager Myclausen, herunder:
English: There have been isolated reports of interstitial lung disease and pulmonary fibrosis in patients treated with mycophenolate mofetil in combination with other immunosuppressants, some of which have been fatal.
Danish: Der er rapporteret om enkelte tilfælde af interstitiel lungesygdom og lungefibrose hos patienter, som fik mycophenolatmofetil i kombination med andre immunosuppressiva.
English: In some of these cases switching mycophenolate mofetil to an alternative immunosuppressant resulted in serum IgG levels returning to normal.
Danish: I nogle af disse tilfælde blev serum-IgG normaliseret, når Mycophenolatmofetil blev erstattet af alternative immunsuppressiva.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 500 mg mycophenolate mofetil. For the full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver filmovertrukket tablet indeholder 500 mg mycophenolatmofetil.
English: · The Package Leaflet · Guide for patients
Danish: Informationsmaterialet for patienter skal indeholde: · Indlægsseddel · En vejledning for patienter
English: • The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses.
Danish: • Den daglige dosis er 6 tabletter (3 g af medicinen) indtaget som 2 separate doser.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/647/001
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Myclausen, skal du henvende dig til den lokale repræsentant:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/647/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/10/647/002
English: 5 How to store Myclausen 6 Contents of the pack and other information
Danish: 6 Pakningsstørrelser og yderligere oplysninger
English: • The daily dose is 12 capsules (3 g of the medicine) taken as 2 separate doses.
Danish: • Den daglige dosis er 12 kapsler (3 g af medicinen) indtaget som 2 separate doser.
English: Capsule content: pre-gelatinised starch (maize), croscarmellose sodium, povidone (K-30), magnesium stearate
Danish: Prægelatineret stivelse (majs), croscarmellosesodium, povidon (K-30), magnesiumstearat Kapselskallen:
English: Digestive system and mouth problems such as:
Danish: Lidelser i mave-tarm-kanalen og i munden såsom:
English: The patient information pack should contain:
Danish: Oversigt over indlægssedlen:
English: No data are available for cardiac transplant patients with severe hepatic parenchymal disease.
Danish: Der findes ingen tilgængelige data for hjertetransplanterede patienter med svær leverparenkymsygdom.
English: In teratology studies in rats and rabbits, foetal resorptions and malformations occurred in rats at 6 mg/kg/day (including anophthalmia, agnathia, and hydrocephaly) and in rabbits at 90 mg/kg/day (including cardiovascular and renal anomalies, such as ectopia cordis and ectopic kidneys, and diaphragmatic and umbilical hernia), in the absence of maternal toxicity.
Danish: anophthalmi, agnathi og hydrocephalus) og hos kaniner ved 90 mg/kg/dag (inkl.
English: • swelling of the gums and mouth ulcers
Danish: • hævede gummer og sår i mundhulen
English: Common Arthralgia
Danish: Mavetarmkanalen
English: Full patient information about the teratogenic risk and the pregnancy prevention measures should be given by the physician to women of childbearing potential and, as appropriate, to male patients.
Danish: Lægen skal give fertile kvinder og mænd udførlig information om de teratogene risici og forholdsregler til at forebygge graviditet.
English: Decrease in MPA Cmax and AUC (0-12h) by 30 % and 25 %, respectively, were observed when mycophenolate mofetil was concomitantly administered with sevelamer without any clinical consequences (i.e. graft rejection).
Danish: AUC0-12 timer med henholdsvis 30 % og 25 %, dog uden at dette havde kliniske konsekvenser (f.eks.
English: The mean bioavailability of oral mycophenolate mofetil, based on MPA AUC, is 94 % relative to IV mycophenolate mofetil. Food had no effect on the extent of absorption (MPA AUC) of mycophenolate mofetil when administered at doses of 1.5 g BID to renal transplant patients.
Danish: Oral mycophenolatmofetils gennemsnitlige biotilgængelighed, baseret på MPA-AUC, er 94 % i forhold til i.v.
English: Ciclosporin A
Danish: Ciclosporin
English: If you take more Myclausen than you should
Danish: Hvis du har taget for mange Myclausen
English: Vomiting, abdominal pain, diarrhoea, nausea
Danish: Bivirkninger Almindelig Pleural effusion, dyspnø, hoste
English: Myclausen is contraindicated during pregnancy unless there is no suitable alternative treatment to prevent transplant rejection.
Danish: Myclausen er kontraindiceret under graviditet, medmindre der ikke findes en hensigtsmæssig alternativ behandling, og for at udelukke en uønsket anvendelse under graviditet må behandling ikke initieres, uden at en negativ graviditetstest foreligger.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 250 mg mycophenolate mofetil. For the full list of excipients, see section 6.1.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 250 mg mycophenolatmofetil.
English: If you are not sure, talk to your doctor or pharmacist before taking Myclausen.
Danish: Spørg lægen eller på apoteket, før du tager Myclausen, hvis der er noget, du er i tvivl om.
English: Myclausen should be used together with other medicines:
Danish: Myclausen skal bruges sammen med anden medicin: • ciclosporin og kortikosteroider.
English: What Myclausen looks like and contents of the pack
Danish: Pakningsstørrelser og yderligere oplysninger Myclausen indeholder
English: Congenital disorders
Danish: Medfødte misdannelser
English: Common Convulsion, hypertonia, tremor, somnolence,
Danish: Meget almindelig Almindelig Kramper, hypertoni, tremor, somnolens, muskelsvaghed, svimmelhed, hovedpine, paræstesier, smagsforstyrrelser
English: Skin problems such as • acne, cold sores, shingles, skin growth, hair loss, rash, itching.
Danish: • akne, forkølelsessår, helvedesild (herpes zoster), øget hudvækst, hårtab, udslæt, kløe.
English: By interfering with enterohepatic circulation of the medicinal product, bile acid sequestrants such as cholestyramine, reduce MPA AUC (see section 4.9).
Danish: Galdesyrekompleksdannere såsom colestyramin, reducerer MPAs AUC ved at inteferere med det enterohepatiske kredsløb af lægemidlet (se pkt.
English: Common Oedema, pyrexia, chills, pain, malaise, asthenia
Danish: Meget almindelig Almindelig Ødemer, feber, kulderystelser, smerter, utilpashed, asteni
English: Myclausen capsules at a dose of 750 mg twice daily (1.5 g daily dose).
Danish: Patienter med en legemsoverflade på 1,25 til 1,5 m² kan ordineres Myclausen kapsler i en dosis på 750 mg to gange dalig (daglig dosis: 1,5 g).
English: Possible side effects
Danish: Generelle bivirkninger
English: Tablet coating
Danish: Nedsat nyrefunktion
English: The overall safety profile is considered acceptable.
Danish: Den samlede sikkerhedsprofil vurderes at være acceptabel.
English: This is a summary of the European public assessment report (EPAR) for Lokelma.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Lokelma.
English: The full EPAR for Lokelma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Lokelma findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The powder is stirred into water to make a mixture to be drunk straight away.
Danish: Pulveret omrøres i vand til en blanding, der skal drikkes med det samme.
English: The recommended starting dose of Lokelma is 10 g three times a day.
Danish: Den anbefalede startdosis af Lokelma er 10 g tre gange dagligt.
English: Other information about Lokelma
Danish: Andre oplysninger om Lokelma
English: It is not intended to provide practical advice on how to use Lokelma.
Danish: Det er ikke en praktisk vejledning i, hvordan Lokelma bør anvendes.
English: What measures are being taken to ensure the safe and effective use of Lokelma?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Lokelma?
English: What is Lokelma and what is it used for?
Danish: Hvad er Lokelma, og hvad anvendes det til?
English: The European Medicines Agency decided that Lokelma's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Lokelma opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Why is Lokelma approved?
Danish: Hvorfor blev Lokelma godkendt?
English: What are the risks associated with Lokelma?
Danish: Hvilke risici er der forbundet med Lokelma?
English: Lokelma is available as powder sachets (5 g and 10 g).
Danish: Lokelma fås som pulver i breve (5 g og 10 g).
English: is then eliminated in the stools.
Danish: udskilles i afføringen.
English: The Agency considered that Lokelma is effective at controlling blood potassium levels, especially during initial (acute) treatment.
Danish: Agenturet vurderede, at Lokelma er effektivt til at kontrollere kaliumniveauet i blodet, navnlig ved initial (akut) behandling.
English: For more information about treatment with Lokelma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Lokelma, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: When taken by mouth, Lokelma attaches to potassium from food and body fluids in the gut, forming a compound that
Danish: Når Lokelma tages gennem munden, binder det til kalium fra føde og kropsvæsker i tarmen og danner en forbindelse, der
English: Once the blood levels of potassium return within the normal range (usually within 1-2 days), patients should take the lowest effective dose of Lokelma to prevent the return of hyperkalaemia, starting with 5 g once a day and not exceeding 10 g once a day.
Danish: Når kaliumniveauet i blodet er normaliseret (typisk inden for 1-2 dage), bør patienterne tage den laveste virksomme dosis Lokelma til forebyggelse af fornyet hyperkaliæmi, startende med 5 g én gang dagligt og højst 10 g én gang dagligt.
English: The most common side effects with Lokelma (which may affect up to 1 in 10 people) are oedema (fluid build-up with swelling in the ankles and feet) and hypokalaemia (low levels of potassium in the blood).
Danish: De hyppigste bivirkninger ved Lokelma (der kan forekomme hos op til 1 ud af 10 patienter) er ødem (væskeophobning med hævede ankler og fødder) og hypokaliæmi (lavt kaliumniveau i blodet).
English: Another main study involved 258 patients who had normal potassium levels after Lokelma treatment.
Danish: En anden hovedundersøgelse omfattede 258 patienter, der opnåede normalt kaliumniveau efter behandling med Lokelma.
English: It contains the active substance sodium zirconium cyclosilicate.
Danish: Det indeholder det aktive stof natriumzirkoniumcyklosilikat.
English: Lokelma is a medicine used to treat hyperkalaemia (high levels of potassium in the blood) in adults.
Danish: Lokelma er et lægemiddel, der anvendes til behandling af hyperkaliæmi (forhøjet kaliumniveau i blodet) hos voksne.
English: In a main study of 754 patients with hyperkalaemia, 86% of patients taking Lokelma 10 g had normal potassium levels after 2 days compared with 48% of those taking placebo (a dummy treatment).
Danish: I en hovedundersøgelse af 754 patienter med hyperkaliæmi havde 86 % af de patienter, der fik Lokelma 10 g, normalt kaliumniveau efter 2 dage, sammenholdt med 48 % af de patienter, der fik placebo (ikke-aktivt stof).
English: In addition, when patients who had normal potassium levels after Lokelma treatment were given further treatment with either Lokelma or placebo, potassium levels stayed normal for longer with Lokelma than with placebo.
Danish: Når patienter, der havde opnået normalt kaliumniveau efter behandling med Lokelma, fik yderligere behandling med enten Lokelma eller placebo, forblev kaliumniveauet desuden normalt i længere tid ved indtagelse af Lokelma end ved indtagelse af placebo.
English: For practical information about using Lokelma, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Lokelma, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: In this 4-week study, patients receiving further treatment with Lokelma had lower potassium levels from the second week of treatment than patients taking placebo.
Danish: I denne 4-ugers undersøgelse havde de patienter, der fik yderligere behandling med Lokelma, et lavere kaliumniveau i anden behandlingsuge end patienter, der fik placebo.
English: For the full list of all side effects and restrictions with Lokelma, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Lokelma fremgår af indlægssedlen.
English: This action removes potassium from the body overall, thus helping to lower the potassium levels in the blood.
Danish: Ved denne proces fjernes kalium fra kroppen, hvorved kaliumniveauet i blodet mindskes.
English: Lokelma is effective at lowering blood potassium levels and keeping levels of potassium within the normal range.
Danish: Lokelma er effektivt til at sænke kaliumniveauet i blodet og holde det inden for normalområdet.
English: The active substance in Lokelma, sodium zirconium cyclosilicate, is a potassium binder.
Danish: Det aktive stof i Lokelma, natriumzirkoniumcyklosilikat, er et kaliumbindende stof.
English: Lokelma sodium zirconium cyclosilicate
Danish: Lokelma natriumzirkoniumcyklosilikat
English: How is Lokelma used?
Danish: Hvordan anvendes Lokelma?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lokelma have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Lokelma.
English: What benefits of Lokelma have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Lokelma?
English: How does Lokelma work?
Danish: Hvordan virker Lokelma?
English: Symptoms include:
Danish: Symptomerne omfatter:
English: • hallucinations (seeing or hearing things that are not there).
Danish: • hallucinationer (ser eller hører ting, der ikke findes).
English: If at any time you have these thoughts,
Danish: Hvis du på noget tidspunkt oplever sådanne tanker:
English: Thoughts of harming yourself or suicide
Danish: Tanker om at skade dig selv eller begå selvmord
English: Suicide risk
Danish: Selvmordsrisiko
English: The duration of the maintenance phase was 8 or 12 weeks.
Danish: Vedligeholdelsesfasen varede 8 eller 12 uger.
English: Weight increased Increased appetite
Danish: Vægtøgning Øget appetit
English: • difficulty in reading, writing or saying what you mean, or difficulty in understanding words
Danish: • besvær med at læse, skrive eller sige, hvad du mener, eller problemer med at forstå ord
English: Treatment will be stopped if any problems are found unless no other suitable treatments are available.
Danish: Behandlingen stoppes, hvis der opstår problemer, medmindre der ikke findes en anden passende behandling.
English: The safety and efficacy are not yet known in this age group.
Danish: Sikkerheden og virkningen er endnu ikke kendt i denne aldersgruppe.
English: It may take a few weeks to find the right dose of Trobalt for you.
Danish: Det kan tage nogle få uger at finde frem til den rigtige dosis af Trobalt til dig.
English: Patients could not be seizure-free for ≥21 days.
Danish: Patienterne måtte ikke være anfaldsfri i ≥ 21 dage.
English: Elderly (65 years of age and above)
Danish: Ældre (65 år og derover)
English: Study (n=population in double-blind phase; n=population in maintenance phase)
Danish: Studie (n = population i dobbeltblindet fase, n = population i vedligeholdelsesfase)
English: Retigabine mg/day mg/day mg/day
Danish: Retigabin mg/dag mg/dag mg/dag
English: At first, these changes might not affect your sight but, over time, it may get worse.
Danish: Først er dit syn måske ikke påvirket af disse ændringer, men over tid kan dit syn forværres.
English: If you suddenly stop taking Trobalt, your seizures may come back or get worse.
Danish: Hvis du pludselig holder op med at tage Trobalt, kan dine anfald vende tilbage eller blive værre.
English: Tell your doctor if any of these apply to you, or if you notice any unusual changes in your heart beat (such as beating too fast or too slow).
Danish: Fortæl det til lægen, hvis noget af ovenstående gælder for dig, eller hvis du bemærker usædvanlige ændringer i dine hjerteslag (f.eks. at hjertet slår for hurtigt eller for langsomt).
English: Look out for serious symptoms
Danish: Hold øje med alvorlige symptomer
English: See 'Look out for serious symptoms' in section 4.
Danish: Se 'Hold øje med alvorlige symptomer' under punkt 4.
English: The doctor may decide to give you a reduced dose.
Danish: Lægen kan beslutte at give dig en mindre dosis.
English: If continued, the patient should be monitored more closely.
Danish: Hvis behandlingen fortsættes, skal patienten monitoreres tættere.
English: Extremadura 3, 09400 Aranda De Duero, Burgos, Spain.
Danish: Extremadura 3, 09400 Aranda De Duero, Burgos, Spanien.
English: The cumulative incidences of an event at 1 year, 2 years, 3 years, 4 years and 5 years of exposure are approximately 1%, 1.8%, 4.4%, 10.2% and 16.7% respectively.
Danish: Den kumulative frekvens for en sådan bivirkning efter 1 år, 2 år, 3 år, 4 år og 5 års eksponering er henholdsvis ca. 1 %, 1,8 %, 4,4 %, 10,2 % og 16,7 %.
English: Interaction with digoxin
Danish: Interaktion med digoxin
English: The relevance of these models to human epilepsy, however, is not known.
Danish: Relevansen af disse modeller for epilepsi hos mennesker kendes imidlertid ikke.
English: Talc (E553b)
Danish: Talcum (E553b)