FrancophonIA/ELRC3.0 huggingface dataset:
English: The daily dose is chosen and adjusted during treatment for each patient depending on the patient's age, liver function and levels of bile acids in their blood and urine.
Danish: Den daglige dosis fastsættes og justeres under behandlingen for hver enkelt patient, alt efter dennes alder, leverfunktion og galdesyreniveau i blod og urin.
English: Among 23 patients for whom data on blood levels of bile acids were available, all had reductions in their levels (average reduction of 56-69 µmol/l).
Danish: Blandt 23 patienter, hvis data om galdesyreniveau i blodet var tilgængelige, sås en reduktion hos alle (gennemsnitlig reduktion på 56-69 µmol/l).
English: Chenodeoxycholic acid Leadiant is available as capsules (250 mg) which are taken 3 times a day at approximately the same time every day.
Danish: Chenodeoxycholic acid Leadiant fås som kapsler (250 mg), der tages 3 gange dagligt på nogenlunde samme tidspunkt hver dag.
English: Since Chenodeoxycholic acid Leadiant has been approved under exceptional circumstances, the company that markets this medicine will set up a registry to monitor the benefits and safety of the medicine.
Danish: Da Chenodeoxycholic acid Leadiant er godkendt under særlige omstændigheder, vil den virksomhed, der markedsfører lægemidlet, oprette et register til overvågning af lægemidlets fordele og sikkerhed.
English: Among 14 patients for whom data on urine levels of bile acids were available, 79% (11 out of 14) had reduced levels at their most recent test.
Danish: Blandt 14 patienter, hvis data om galdesyreniveau i urinen var tilgængelige, sås en reduktion hos 79 % (11 ud af 14) i de seneste test.
English: This helps to reduce the production of abnormal substances and contributes to the normal activity of bile in the digestive system, thereby relieving the symptoms of the disease.
Danish: Derved nedsættes produktionen af unormale stoffer, og galdens normale aktivitet i fordøjelsessystemet fremmes, så sygdommens symptomer lindres.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Chenodeoxycholic acid Leadiant's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Chenodeoxycholic acid Leadiant opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: This is a ‘primary bile acid', which is a main component of bile (a fluid produced by the liver that helps to digest fats).
Danish: Dette er en "primær galdesyre", som er en hovedbestanddel i galden (den væske, der produceres af leveren og medvirker ved fordøjelsen af fedtstoffer).
English: When primary bile acids are lacking, the body produces abnormal bile acids and other substances instead which accumulate throughout the body, causing damage.
Danish: Når der ingen galdesyre er, producerer kroppen i stedet anormale galdesyrer og andre stoffer, som ophober sig i kroppen og forvolder skade.
English: Because the number of patients with this condition is low, the disease is considered ‘rare', and Chenodeoxycholic acid Leadiant was designated an ‘orphan medicine' (a medicine used in rare diseases) on 16 December 2014.
Danish: Da antallet af patienter med denne sygdom er lavt, betragtes sygdommen som "sjælden", og Chenodeoxycholic acid Leadiant blev udpeget som "lægemiddel til sjældne sygdomme" den 16. december 2014.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Chenodeoxycholic acid sigma-tau on 10 April 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Chenodeoxycholic acid Leadiant den 10. april 2017.
English: The full EPAR for Chenodeoxycholic acid Leadiant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Chenodeoxycholic acid Leadiant findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is because it has not been possible to obtain complete information about Chenodeoxycholic acid Leadiant due to the rarity of the disease.
Danish: Det skyldes, at det ikke har været muligt at indhente fyldestgørende oplysninger om Chenodeoxycholic acid Leadiant, fordi sygdommen er sjælden.
English: This is a summary of the European public assessment report (EPAR) for Chenodeoxycholic acid Leadiant.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Chenodeoxycholic acid Leadiant.
English: Chenodeoxycholic acid has been used to treat cerebrotendinous xanthomatosis for about 40 years, although it was not licensed for this use.
Danish: Chenodeoxycholsyre har været anvendt til behandling af cerebrotendinøs xantomatose i ca. 40 år, selvom det ikke var godkendt til denne anvendelse.
English: The name of the product was changed to Chenodeoxycholic acid Leadiant on 12 May 2017.
Danish: Lægemidlets navn blev ændret til Chenodeoxycholic acid Leadiant den 12. maj 2017.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Chenodeoxycholic acid Leadiant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Chenodeoxycholic acid Leadiant findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: For more information about treatment with Chenodeoxycholic acid Leadiant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Chenodeoxycholic acid Leadiant, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Chenodeoxycholic acid Leadiant has been authorised under ‘exceptional circumstances'.
Danish: Chenodeoxycholic acid Leadiant er godkendt under "særlige omstændigheder".
English: However, Xenbilox differs from Chenodeoxycholic acid Leadiant in that it is authorised for a different use (to dissolve cholesterol gallstones).
Danish: Xenbilox adskiller sig imidlertid fra Chenodeoxycholic acid Leadiant ved at være godkendt til en anden anvendelse (opløsning af galdesten).
English: For the list of restrictions, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
English: Previously known as Chenodeoxycholic acid sigma-tau.
Danish: Tidligere kendt som Chenodeoxycholic acid sigma-tau.
English: These patients cannot produce enough of the primary bile acid chenodeoxycholic acid due to genetic abnormalities that result in a lack of the liver enzyme sterol 27 hydroxylase.
Danish: Disse patienter kan ikke producere nok af den primære galdesyre (chenodeoxycholsyre) på grund af genetiske afvigelser og mangler derfor leverenzymet sterol-27-hydroxylase.
English: Chenodeoxycholic acid Leadiant has been investigated in a study which looked at the records of 35 patients with cerebrotendinous xanthomatosis who received chenodeoxycholic acid for around 9 years.
Danish: Chenodeoxycholic acid Leadiant er blevet vurderet i en undersøgelse, hvor man så på journalerne fra 35 patienter med cerebrotendinøs xantomatose, der fik chenodeoxycholsyre i ca. 9 år.
English: Chenodeoxycholic acid Leadiant can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cerebrotendinous xanthomatosis or other diseases of primary bile acid production.
Danish: Chenodeoxycholic acid Leadiant udleveres kun efter recept, og behandlingen bør indledes og overvåges af en læge med erfaring i behandling af cerebrotendinøs xantomatose eller andre sygdomme med nedsat produktion af primære galdesyrer.
English: The chenodeoxycholic acid contained in this medicine replaces the patient's missing chenodeoxycholic acid.
Danish: Chenodeoxycholsyren i dette lægemiddel erstatter patientens manglende chenodeoxycholsyre.
English: Chenodeoxycholic acid Leadiant is used to treat adults and children from one month of age with cerebrotendinous xanthomatosis.
Danish: Chenodeoxycholic acid Leadiant anvendes til behandling af voksne og børn fra 1-månedsalderen og derover med cerebrotendinøs xanthomatose.
English: Chenodeoxycholic acid Leadiant is a ‘hybrid medicine'.
Danish: Chenodeoxycholic acid Leadiant er et "hybridt lægemiddel".
English: For practical information about using Chenodeoxycholic acid Leadiant, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Chenodeoxycholic acid Leadiant, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Chenodeoxycholic acid Leadiant is a medicine that contains the active substance chenodeoxycholic acid.
Danish: Chenodeoxycholic acid Leadiant er et lægemiddel, der indeholder det aktive stof chenodeoxycholsyre.
English: What is Chenodeoxycholic acid Leadiant and what is it used for?
Danish: Hvad er Chenodeoxycholic acid Leadiant, og hvad anvendes det til?
English: The reference medicine for Chenodeoxycholic acid Leadiant is Xenbilox.
Danish: Referencelægemidlet for Chenodeoxycholic acid Leadiant er Xenbilox.
English: What measures are being taken to ensure the safe and effective use of Chenodeoxycholic acid Leadiant?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Chenodeoxycholic acid Leadiant?
English: Chenodeoxycholic acid is one of the main primary bile acids produced by the liver.
Danish: Chenodeoxycholic acid Leadianter en af de vigtigste primære galdesyrer, der produceres af leveren.
English: Other information about Chenodeoxycholic acid Leadiant
Danish: Andre oplysninger om Chenodeoxycholic acid Leadiant
English: What information is still awaited for Chenodeoxycholic acid Leadiant?
Danish: Hvilke oplysninger afventes der stadig for Chenodeoxycholic acid Leadiant?
English: It is not intended to provide practical advice on how to use Chenodeoxycholic acid Leadiant.
Danish: Det er ikke en praktisk vejledning i, hvordan Chenodeoxycholic acid Leadiant bør anvendes.
English: Why is Chenodeoxycholic acid Leadiant approved?
Danish: Hvorfor blev Chenodeoxycholic acid Leadiant godkendt?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Chenodeoxycholic acid Leadiant have been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Chenodeoxycholic acid Leadiant.
English: What are the risks associated with Chenodeoxycholic acid Leadiant?
Danish: Hvilke risici er der forbundet med Chenodeoxycholic acid Leadiant?
English: How is Chenodeoxycholic acid Leadiant used?
Danish: Hvordan anvendes Chenodeoxycholic acid Leadiant?
English: chenodeoxycholic acid
Danish: Chenodeoxycholic acid Leadiant chenodeoxycholsyre
English: How does Chenodeoxycholic acid Leadiant work?
Danish: Hvordan virker Chenodeoxycholic acid Leadiant?
English: What benefits of Chenodeoxycholic acid Leadiant have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Chenodeoxycholic acid Leadiant?
English: 21 February 2011
Danish: 21. februar 2011
English: This leads to improvement in the patient's symptoms.
Danish: Dette fører til en forbedring af patientens symptomer.
English: Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Danish: Resultatet af en procedure under Artikel 29 i Direktiv 2001/83/EF (som ændret)
English: The European Commission issued a decision on this referral on 21 February 2011.
Danish: Europa-kommissionen traf en afgørelse om denne indbringelse den 21. februar 2011.
English: What are the conclusions of the CHMP?
Danish: Hvad er CHMP's konklusion?
English: However, the Member States were not able to reach an agreement and the Czech Republic referred the matter to the CHMP for arbitration on 26 March 2010.
Danish: Disse medlemsstater kunne imidlertid ikke nå til enighed, og Den Tjekkiske Republik henviste sagen til CHMP til voldgift den 26 marts 2010.
English: Following the CHMP opinion on 23 September 2010, the Agency was informed on 15 October 2010 that the company withdrew the applications for marketing authorisation in all concerned Member States.
Danish: Efter udtalelsen fra CHMP den 23. september 2010 modtog agenturet den 15. oktober 2010 oplysninger om, at virksomheden trak sin ansøgning om markedsføringstilladelse tilbage i alle de berørte medlemsstater.
English: What is Galantamine Stada?
Danish: Hvad er Galantamin Stada?
English: Alfred E. Tiefenbacher GmbH & Co KG submitted Galantamine Stada to the Austrian medicines regulatory agency for a decentralised procedure.
Danish: Alfred E. Tiefenbacher GmbH & Co KG indgav en ansøgning for Galantamin Stada til den østrigske lægemiddelkontrolmyndighed med henblik på en decentral procedure.
English: Why was Galantamine Stada reviewed?
Danish: Hvorfor blev Galantamin Stada vurderet igen?
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Galantamine Stada.
Danish: Det Europæiske Lægemiddelagentur har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem EU-medlemsstater vedrørende godkendelsen af lægemidlet Galantamin Stada.
English: It is used to treat symptoms of mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Danish: Det anvendes til at behandle symptomer på mild til moderat alvorlig Alzheimers demens, en progressiv hjernelidelse, som gradvist påvirker hukommelsen, de intellektuelle evner og opførslen.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that bioequivalence to the reference medicinal product has not been shown.
Danish: På grundlag af vurderingen af de aktuelt foreliggende data og den faglige drøftelse i udvalget var CHMP af den opfattelse, at der ikke var påvist bioækvivalens med referencelægemidlet.
English: The CHMP therefore concluded that the benefits of Galantamine Stada do not outweigh its risks and recommended that the marketing authorisation should not be granted in the concerned Member States.
Danish: CHMP konkluderede derfor, at fordelene ved Galantamin Stada ikke opvejer risiciene, og at der derfor ikke bør udstedes markedsføringstilladelse i de berørte medlemsstater.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Galantamine Stada do not outweigh its risks, and the marketing authorisation cannot be granted in Austria or in other Member States of the EU: Czech Republic, Denmark, Finland, Ireland, Portugal, Slovakia and Spain.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Galantamin Stada ikke opvejer risiciene og at der ikke kan gives markedsføringstilladelse i Østrig eller i andre EU-medlemsstater: Den Tjekkiske Republik, Danmark, Finland, Irland, Portugal, Slovakiet og Spanien.
English: The grounds for the referral were that bioequivalence studies, to show that Galantamine Stada produces the same levels of active substance in the body as Reminil, had not been conclusive.
Danish: Begrundelsen for indbringelsen var, at de bioækvivalensundersøgelser, der skulle vise at Galantamin Stada danner de samme niveauer af det aktive stof i kroppen som Reminyl, ikke var entydige.
English: Galantamine Stada is a medicine that contains the active substance galantamine.
Danish: Galantamin Stada er et lægemiddel, der indeholder det aktive stof galantamin.
English: Galantamine Stada is a generic medicine based on a ‘reference medicine', Reminyl.
Danish: Galantamin Stada er et generisk lægemiddel, der er baseret på 'referencelægemidlet' Reminyl.
English: By blocking this enzyme, galantamine allows levels of acetylcholine to be increased in the parts of the brain associated with intellectual function.
Danish: Når dette enzym blokeres, kan koncentrationen af acetylcholin øges i de dele af hjernen, der har relation til de intellektuelle funktioner.
English: In patients with Alzheimer's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).Galantamine works by blocking acetylcholinesterase, an enzyme that breaks down acetylcholine.
Danish: Hos patienter med Alzheimers sygdom dør visse nerveceller i hjernen, hvilket medfører lave koncentrationer af neurotransmitteren acetylcholin (et stof, der sætter nervecellerne i stand til at kommunikere med hinanden).
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Austria) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance the Czech Republic, Denmark, Estonia, Finland, Ireland, Portugal, Slovakia and Spain).
Danish: henblik på udstedelse af en markedsføringstilladelse, som gælder både nationalt og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Den Tjekkiske Republik, Danmark, Estland, Finland, Irland, Portugal, Slovakiet og Spanien).
English: EU Number
Danish: EU)-nummer
English: The Safety Information Communication should contain the following:
Danish: Sikkerhedsinformationsmeddelelsen skal indeholde følgende:
English: The anticipated effects of overdose (e.g. bone marrow suppression).
Danish: De forventede virkninger af overdosis (f.eks. knoglemarvssuppression).
English: The risk of medication error due to the higher concentration than the dilution concentration of the originator, with potentially life-threatening consequences.
Danish: Risikoen for medicineringsfejl på grund af den højere koncentration end fortyndingskoncentrationen af originalmidlet, med potentielt livstruende konsekvenser.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemsstaterne skal sikre, at alle de betingelser eller begrænsninger med hensyn til sikker og effektiv anvendelse af lægemidlet, som er beskrevet nedenfor, indføres:
English: Prior to launch of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of a Safety Information Communication with the national competent authority, including the need and the timing of any follow-up Safety Communication Information, as well as the distribution list of such information.
Danish: Inden produktet markedsføres i medlemsstaten, skal indehaveren af markedsføringstilladelsen aftale sikkerhedsinformationsmeddelelsens indhold og format med den nationale kompetente myndighed, herunder behov og tidspunkt for eventuelle efterfølgende sikkerhedsinformationsmeddelelser samt
English: Reference to the vial collar as visual reminder of this difference and the instruction that it must
Danish: Reference til hætteglassets krave som en visuel påmindelse om denne forskel, og den instruktion, at den ikke på noget tidspunkt må fjernes.
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch, all Healthcare Professionals who are expected to use and/or prescribe Topotecan Eagle are provided with a Safety Information Communication.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at alle fagfolk inden for sundhedssektoren, som forventes at anvende og/eller ordinere Topotecan Eagle, har modtaget sikkerhedsinformationsmeddelelsen på markedsføringstidspunktet.
English: An encouragement of reporting of actual medication errors and any safety events that might be
Danish: En opfordring til at rapportere faktiske medicineringsfejl og eventuelle sikkerhedshændelser, som kunne være en følge af en medicineringsfejl.
English: Annex
Danish: BILAG
English: • Information on crisis or infections
Danish: • Information om kriser og infektioner
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, DER SKAL IMPLEMENTERES AF MEDLEMSLANDENE
English: • Key signs and symptoms of serious adverse reactions
Danish: • Vigtige tegn og symptomer på alvorlige bivirkninger
English: The treatment guide for physicians should contain the following key elements:
Danish: Behandlingsvejledningen for læger skal indeholde følgende nøgleelementer:
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemslandene skal sikre, at alle betingelser eller begrænsninger vedrørende sikker og effektiv anvendelse af det lægemiddel, der beskrives i det følgende, implementeres:
English: The Marketing Authorisation Holder (MAH) shall ensure that, prior to launch, all physicians who are expected to prescribe Siklos are provided with a physician information pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen skal inden lanceringen sikre, at alle læger, der forventes at ordinere Siklos, får udleveret en informationspakke, der indeholder følgende:
English: • Treatment guide for physicians
Danish: • Behandlingsvejledning for læger
English: • Need for periodic blood counts and dose adjustment
Danish: • Behovet for regelmæssige blodtællinger og dosisjustering
English: • When to seek urgent attention from the health care provider
Danish: • Hvornår der er behov for øjeblikkelig lægehjælp
English: • Need for periodic blood counts
Danish: • Behovet for regelmæssige blodtællinger
English: • Patient information pack
Danish: • Patientinformationspakke.
English: • Information on growth follow-up of treated children for their parents
Danish: • Information til forældre om kontrol af behandlede børns vækst
English: • Growth follow-up of treated children
Danish: • Kontrol af behandlede børns vækst
English: • Management of adverse drug reactions
Danish: • Administration af uønskede lægemiddelbivirkninger
English: The MAH must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States
Danish: Før lægemidlet lanceres i de enkelte medlemslande, skal indehaveren af markedsføringstilladelsen blive enig med den relevante nationale myndighed om format og indhold af uddannelsesmaterialet.
English: • Package leaflet
Danish: • Indlægssedlen
English: • Risk of medication error due to the availability of two different strengths The patient information pack should contain the following key elements:
Danish: Patientinformationspakken skal indeholde følgende nøgleelementer:
English: This summary was last updated in 02-2016.
Danish: Dette sammendrag blev sidst ajourført i 06-2015.
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST-segment-elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Danish: Dette efterfølges så af en standarddosis på 75 mg én gang dagligt i mindst fire uger (ved myokardieinfarkt med ST-segmentelevation) eller i op til 12 måneder (ved ustabil angina eller non-Q-tak-myokardieinfarkt).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Clopidogrel Teva Pharma.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Clopidogrel HCS skal anvendes.