natgillin/translations-raw huggingface dataset:
Andre blødninger (inklusive næseblod, postprocedural blødning og hæmaturi) 
Other bleeding (including epistaxis, post-procedural haemorrhage and haematuria)
Hver tablet indeholder 20 mg ruxolitinib (som fosfat). 
Each tablet contains 20 mg ruxolitinib (as phosphate).
Hver tablet indeholder 5 mg ruxolitinib (som fosfat). 
Each tablet contains 5 mg ruxolitinib (as phosphate).
Hver tablet indeholder 15 mg ruxolitinib (som fosfat). 
Each tablet contains 15 mg ruxolitinib (as phosphate).
Hver tablet indeholder 10 mg ruxolitinib (som fosfat). 
Each tablet contains 10 mg ruxolitinib (as phosphate).
Jakavi 5 mg tabletter er hvide eller næsten hvide, runde tabletter præget med ”NVR” på den ene side og ”L5” på den anden side. 
What Jakavi looks like and contents of the pack Jakavi 5 mg tablets are white to almost white round tablets with “NVR” debossed on one side and “L5” debossed on the other side.
Bivirkninger 
Withdrawal effects
De var milde eller moderate og var ikke vedvarende. 
They were mild or moderate in severity and did not last.
Det betyder, at det svarer til et "referencelægemiddel", som indeholder det samme aktive stof. 
This means that it is similar to a ‘reference medicine' containing the same active substance.
Undersøgelser har ikke desto mindre vist, at patienterne har gavn af lægemidlet uden at have væsentlige bivirkninger. 
Nevertheless, studies have shown that the medicine benefits patients and has no significant side effects.
For små børn og børn, der ikke kan sluge kapsler, kan indholdet af kapslerne blandes i en natriumbikarbonatopløsning 8,4 %, så man opnår en væske. 
For small children and children who cannot swallow capsules, the contents of the capsules can be mixed with sodium bicarbonate solution 8.4% to make a liquid.
Da der imidlertid er tale om en sjælden sygdom, er de tilgængelige data om brugen af lægemidlet stadig begrænsede. 
However, due to the rarity of the disease, there are still limited data available on the use of the medicine.
Hos de fleste patienter sås også en lindring af sygdommens symptomer: Alle rapporterede om mindre forekomst af diarré, 89 % af patienterne opnåede bedre mentale evner, 60 % opnåede større mobilitet, og i henhold til to forskellige scorer havde 85 % og 77 % af patienterne fået det bedre psykisk. 
Most patients also had improvements in symptoms of the disease: all reported an improvement in diarrhoea, 89% of patients showed an improvement in their mental ability, 60% of patients showed improvement in mobility, and 85% and 77% of patients showed psychiatric improvement based on two different scores.
Den daglige dosis fastsættes og justeres under behandlingen for hver enkelt patient, alt efter dennes alder, leverfunktion og galdesyreniveau i blod og urin. 
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.
Blandt 23 patienter, hvis data om galdesyreniveau i blodet var tilgængelige, sås en reduktion hos alle (gennemsnitlig reduktion på 56-69 µmol/l). 
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).
Chenodeoxycholic acid Leadiant fås som kapsler (250 mg), der tages 3 gange dagligt på nogenlunde samme tidspunkt hver dag. 
Chenodeoxycholic acid Leadiant is available as capsules (250 mg) which are taken 3 times a day at approximately the same time every day.
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. 
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.
Blandt 14 patienter, hvis data om galdesyreniveau i urinen var tilgængelige, sås en reduktion hos 79 % (11 ud af 14) i de seneste test. 
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.
Derved nedsættes produktionen af unormale stoffer, og galdens normale aktivitet i fordøjelsessystemet fremmes, så sygdommens symptomer lindres. 
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.
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. 
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.
Dette er en "primær galdesyre", som er en hovedbestanddel i galden (den væske, der produceres af leveren og medvirker ved fordøjelsen af fedtstoffer). 
This is a ‘primary bile acid', which is a main component of bile (a fluid produced by the liver that helps to digest fats).
Når der ingen galdesyre er, producerer kroppen i stedet anormale galdesyrer og andre stoffer, som ophober sig i kroppen og forvolder skade. 
When primary bile acids are lacking, the body produces abnormal bile acids and other substances instead which accumulate throughout the body, causing damage.
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. 
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.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Chenodeoxycholic acid Leadiant den 10. april 2017. 
The European Commission granted a marketing authorisation valid throughout the European Union for Chenodeoxycholic acid sigma-tau on 10 April 2017.
Den fuldstændige EPAR for Chenodeoxycholic acid Leadiant findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
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.
Det skyldes, at det ikke har været muligt at indhente fyldestgørende oplysninger om Chenodeoxycholic acid Leadiant, fordi sygdommen er sjælden. 
This is because it has not been possible to obtain complete information about Chenodeoxycholic acid Leadiant due to the rarity of the disease.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Chenodeoxycholic acid Leadiant. 
This is a summary of the European public assessment report (EPAR) for Chenodeoxycholic acid Leadiant.
Chenodeoxycholsyre har været anvendt til behandling af cerebrotendinøs xantomatose i ca. 40 år, selvom det ikke var godkendt til denne anvendelse. 
Chenodeoxycholic acid has been used to treat cerebrotendinous xanthomatosis for about 40 years, although it was not licensed for this use.
Lægemidlets navn blev ændret til Chenodeoxycholic acid Leadiant den 12. maj 2017. 
The name of the product was changed to Chenodeoxycholic acid Leadiant on 12 May 2017.
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. 
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.
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. 
For more information about treatment with Chenodeoxycholic acid Leadiant, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Chenodeoxycholic acid Leadiant er godkendt under "særlige omstændigheder". 
Chenodeoxycholic acid Leadiant has been authorised under ‘exceptional circumstances'.
Xenbilox adskiller sig imidlertid fra Chenodeoxycholic acid Leadiant ved at være godkendt til en anden anvendelse (opløsning af galdesten). 
However, Xenbilox differs from Chenodeoxycholic acid Leadiant in that it is authorised for a different use (to dissolve cholesterol gallstones).
Den fuldstændige liste over begrænsninger fremgår af indlægssedlen. 
For the list of restrictions, see the package leaflet.
Tidligere kendt som Chenodeoxycholic acid sigma-tau. 
Previously known as Chenodeoxycholic acid sigma-tau.
Disse patienter kan ikke producere nok af den primære galdesyre (chenodeoxycholsyre) på grund af genetiske afvigelser og mangler derfor leverenzymet sterol-27-hydroxylase. 
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.
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. 
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.
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. 
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.
Chenodeoxycholsyren i dette lægemiddel erstatter patientens manglende chenodeoxycholsyre. 
The chenodeoxycholic acid contained in this medicine replaces the patient's missing chenodeoxycholic acid.
Chenodeoxycholic acid Leadiant anvendes til behandling af voksne og børn fra 1-månedsalderen og derover med cerebrotendinøs xanthomatose. 
Chenodeoxycholic acid Leadiant is used to treat adults and children from one month of age with cerebrotendinous xanthomatosis.
Chenodeoxycholic acid Leadiant er et "hybridt lægemiddel". 
Chenodeoxycholic acid Leadiant is a ‘hybrid medicine'.
Hvis du ønsker praktisk vejledning om anvendelsen af Chenodeoxycholic acid Leadiant, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Chenodeoxycholic acid Leadiant, patients should read the package leaflet or contact their doctor or pharmacist.
Chenodeoxycholic acid Leadiant er et lægemiddel, der indeholder det aktive stof chenodeoxycholsyre. 
Chenodeoxycholic acid Leadiant is a medicine that contains the active substance chenodeoxycholic acid.
Hvad er Chenodeoxycholic acid Leadiant, og hvad anvendes det til? 
What is Chenodeoxycholic acid Leadiant and what is it used for?
Referencelægemidlet for Chenodeoxycholic acid Leadiant er Xenbilox. 
The reference medicine for Chenodeoxycholic acid Leadiant is Xenbilox.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Chenodeoxycholic acid Leadiant? 
What measures are being taken to ensure the safe and effective use of Chenodeoxycholic acid Leadiant?
Chenodeoxycholic acid Leadianter en af de vigtigste primære galdesyrer, der produceres af leveren. 
Chenodeoxycholic acid is one of the main primary bile acids produced by the liver.
Andre oplysninger om Chenodeoxycholic acid Leadiant 
Other information about Chenodeoxycholic acid Leadiant
Hvilke oplysninger afventes der stadig for Chenodeoxycholic acid Leadiant? 
What information is still awaited for Chenodeoxycholic acid Leadiant?
Det er ikke en praktisk vejledning i, hvordan Chenodeoxycholic acid Leadiant bør anvendes. 
It is not intended to provide practical advice on how to use Chenodeoxycholic acid Leadiant.
Hvorfor blev Chenodeoxycholic acid Leadiant godkendt? 
Why is Chenodeoxycholic acid Leadiant approved?
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. 
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.
Hvilke risici er der forbundet med Chenodeoxycholic acid Leadiant? 
What are the risks associated with Chenodeoxycholic acid Leadiant?
Hvordan anvendes Chenodeoxycholic acid Leadiant? 
How is Chenodeoxycholic acid Leadiant used?
Chenodeoxycholic acid Leadiant chenodeoxycholsyre 
chenodeoxycholic acid
Hvordan virker Chenodeoxycholic acid Leadiant? 
How does Chenodeoxycholic acid Leadiant work?
Hvilke fordele viser undersøgelserne, at der er ved Chenodeoxycholic acid Leadiant? 
What benefits of Chenodeoxycholic acid Leadiant have been shown in studies?
21. februar 2011 
21 February 2011
Dette fører til en forbedring af patientens symptomer. 
This leads to improvement in the patient's symptoms.
Resultatet af en procedure under Artikel 29 i Direktiv 2001/83/EF (som ændret) 
Outcome of a procedure under Article 29 of Directive 2001/83/EC as amended
Europa-kommissionen traf en afgørelse om denne indbringelse den 21. februar 2011. 
The European Commission issued a decision on this referral on 21 February 2011.
Hvad er CHMP's konklusion? 
What are the conclusions of the CHMP?
Disse medlemsstater kunne imidlertid ikke nå til enighed, og Den Tjekkiske Republik henviste sagen til CHMP til voldgift den 26 marts 2010. 
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.
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. 
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.
Hvad er Galantamin Stada? 
What is Galantamine Stada?
Alfred E. Tiefenbacher GmbH & Co KG indgav en ansøgning for Galantamin Stada til den østrigske lægemiddelkontrolmyndighed med henblik på en decentral procedure. 
Alfred E. Tiefenbacher GmbH & Co KG submitted Galantamine Stada to the Austrian medicines regulatory agency for a decentralised procedure.
Hvorfor blev Galantamin Stada vurderet igen? 
Why was Galantamine Stada reviewed?
Det Europæiske Lægemiddelagentur har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem EU-medlemsstater vedrørende godkendelsen af lægemidlet Galantamin Stada. 
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.
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. 
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.
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. 
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.
CHMP konkluderede derfor, at fordelene ved Galantamin Stada ikke opvejer risiciene, og at der derfor ikke bør udstedes markedsføringstilladelse i de berørte medlemsstater. 
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.
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. 
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.
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. 
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.
Galantamin Stada er et lægemiddel, der indeholder det aktive stof galantamin. 
Galantamine Stada is a medicine that contains the active substance galantamine.
Galantamin Stada er et generisk lægemiddel, der er baseret på 'referencelægemidlet' Reminyl. 
Galantamine Stada is a generic medicine based on a ‘reference medicine', Reminyl.
Når dette enzym blokeres, kan koncentrationen af acetylcholin øges i de dele af hjernen, der har relation til de intellektuelle funktioner. 
By blocking this enzyme, galantamine allows levels of acetylcholine to be increased in the parts of the brain associated with intellectual function.
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). 
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.
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). 
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).
EU)-nummer 
EU Number
Sikkerhedsinformationsmeddelelsen skal indeholde følgende: 
The Safety Information Communication should contain the following:
De forventede virkninger af overdosis (f.eks. knoglemarvssuppression). 
The anticipated effects of overdose (e.g. bone marrow suppression).
Risikoen for medicineringsfejl på grund af den højere koncentration end fortyndingskoncentrationen af originalmidlet, med potentielt livstruende konsekvenser. 
The risk of medication error due to the higher concentration than the dilution concentration of the originator, with potentially life-threatening consequences.
Medlemsstaterne skal sikre, at alle de betingelser eller begrænsninger med hensyn til sikker og effektiv anvendelse af lægemidlet, som er beskrevet nedenfor, indføres: 
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:
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 
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.
Reference til hætteglassets krave som en visuel påmindelse om denne forskel, og den instruktion, at den ikke på noget tidspunkt må fjernes. 
Reference to the vial collar as visual reminder of this difference and the instruction that it must
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. 
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.
En opfordring til at rapportere faktiske medicineringsfejl og eventuelle sikkerhedshændelser, som kunne være en følge af en medicineringsfejl. 
An encouragement of reporting of actual medication errors and any safety events that might be
BILAG 
Annex
• Information om kriser og infektioner 
• Information on crisis or infections
BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET, DER SKAL IMPLEMENTERES AF MEDLEMSLANDENE 
Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States
• Vigtige tegn og symptomer på alvorlige bivirkninger 
• Key signs and symptoms of serious adverse reactions
Behandlingsvejledningen for læger skal indeholde følgende nøgleelementer: 
The treatment guide for physicians should contain the following key elements:
Medlemslandene skal sikre, at alle betingelser eller begrænsninger vedrørende sikker og effektiv anvendelse af det lægemiddel, der beskrives i det følgende, implementeres: 
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:
Indehaveren af markedsføringstilladelsen skal inden lanceringen sikre, at alle læger, der forventes at ordinere Siklos, får udleveret en informationspakke, der indeholder følgende: 
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:
• Behandlingsvejledning for læger 
• Treatment guide for physicians
• Behovet for regelmæssige blodtællinger og dosisjustering 
• Need for periodic blood counts and dose adjustment
• Hvornår der er behov for øjeblikkelig lægehjælp 
• When to seek urgent attention from the health care provider
• Behovet for regelmæssige blodtællinger 
• Need for periodic blood counts
• Patientinformationspakke. 
• Patient information pack
• Information til forældre om kontrol af behandlede børns vækst 
• Information on growth follow-up of treated children for their parents
• Kontrol af behandlede børns vækst 
• Growth follow-up of treated children
• Administration af uønskede lægemiddelbivirkninger 
• Management of adverse drug reactions
Før lægemidlet lanceres i de enkelte medlemslande, skal indehaveren af markedsføringstilladelsen blive enig med den relevante nationale myndighed om format og indhold af uddannelsesmaterialet. 
The MAH must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States
• Indlægssedlen 
• Package leaflet