natgillin/translations-raw huggingface dataset:
Her er der også refereret fra adskillige publikationer, der omhandler interaktionen. 
Several references from various publications are also listed here.
Der blev undersøgt flere prøveeksemplarer fra samme leverandør, som heller ikke levede op til kravene i standarden pga. manglende angivelse af metaller. 
Several samples from the same supplier were analysed and they did not meet the requirements in the standard either, due to lack of declaration of metals.
Flere videnskabelige selskaber har haft indvendinger mod, at tilskudsændringen ikke indføres fremadrettet, således at kun nye patienter omfattes. 
Several scientific societies have objected to the fact that the reimbursement scheme will also affect current patients, as they would prefer it to apply to future patients only.
Flere stoffer (candesartan, losartan, valsartan) har den registrerede indikation hjerteinsufficiens. 
Several substances (candesartan, losartan and valsartan) have the recorded indication heart insufficiency.
Flere slags naturmedicin kan også virke sløvende og dermed påvirke reaktionsevnen. 
Several types of herbal remedies can also cause drowsiness and thus affect your ability to react.
Der er set alvorlige stråleskader, nogle fatale, efter behandling med Zelboraf. 
Severe radiation injuries, some of which fatal, have been reported after treatment with Zelboraf.
Kønshormoner 
Sex hormones
SGLT2 (Sodium glucose co-transporter 2) hæmmere og udvikling af atypisk ketoacidose hos patienter med type 2 diabetes, side 2 
SGLT2 (sodium-glucose co-transporter 2) inhibitors and development of atypical ketoacidosis in patients with type 2 diabetes, page 2
%-del af sager inden for 30 dage 
Share of cases within 30 days per cent
%-del af sager inden for mål 
Share of cases within targer in per cent
%-del af sager indenfor mål 
Share of cases within targer in per cent
%-del af sager inden for mål 
Share of cases within target in per cent
Andel af humane Rap/Co-rap opgaver 
Share of human Rap/Co-rap cases
Andel af humane Rapporteur/Co-rapporteur opgaver 
Share of human Rap/Co-rap cases
Andel af veterinære Rap/Co-rap opgaver 
Share of veterinary Rap/Co-rap cases
Andel af veterinære Rapporteur/Co-rapporteur opgaver 
Share of veterinary Rap/Co-rap cases
Regionernes andel i kr. (ved 50%) 
Share paid by the regions in DKK (if 50%)
Aktiebeholdninger 
Shareholdings
Hun har en baggrund som speciallæge og ph.d. 
She has a background as a medical specialist and holds a Ph.D.
Hun er cand. oecon. og har tidligere blandt andet været regnskabschef i Sundhedsstyrelsen. 
She has an MSc in economics and was formerly chief accountant of the Danish Health Authority.
Hun har erfaringer med ledelse på højt niveau i forandringsprocesser. 
She has experience in managing change processes.
Hun har haft stor betydning for realiseringen af tilsynsplanen og vil komme til at spille en nøglerolle i det kommende arbejde med at løfte Sundhedsstyrelsens tilsyn til internationalt niveau,” siger Else Smith. 
She has had a major impact on the realisation of the action plan and will be playing a key role in the future work of bringing our supervisory function to an international level,” says Else Smith.
Hun er 45 år, kommer fra en ledende stilling på Nordsjællands Hospital og har også ledererfaring fra IBM og Danske Regioner. 
She is 45 years old, comes from a managerial position at Nordsjællands Hospital and also has management experience from IBM and Danish Regions.
Janne er aktuelt formand for Advisory Board i ViBIS (Videnscenter for Brugerinddragelse i Sundhedsvæsenet). 
She is currently chairman of the Advisory Board of the Danish Knowledge Center for User Involvement in Health Care (ViBIS).
Da der ikke foreligger en diagnose, er det ikke muligt at vurdere en evt. sammenhæng med vaccinerne. 
She subsequently develops stomach ache, back pain, dizziness, joint pain, headache, muscle weakness, orthostatic intolerance and several other symptoms.
Hun har været vicedirektør i Sundhedsstyrelsen og har 25 års erfaring fra ministerområdet, heraf 17 år som leder. 
She was previously Deputy Director General of the Danish Health Authority and has 25 years experience from the ministry's areas of responsibility, 17 years as a manager.
Hun har været vicedirektør i Sundhedsstyrelsen og har 25 års erfaring fra ministerområdet, heraf 17 år som leder. 
She was previously Deputy Director General of the Danish Health Authority and has 25 years experience from the ministry’s areas of responsibility, 17 years as a manager.
Hun tiltræder i dag, den 8. oktober, samtidig med at den nye styrelse dannes. 
She will take up the position today, on 8 October, when the new Danish Patient Safety Authority will also be set up.
Holdbarhed 
Shelf life
Holdbarhed, opbevaringsbetingelser 
Shelf life, storage conditions
Denne type forhandlere skal altså ikke føre hele basissortimentet. 
Shops holding such an authorisation do not have to keep the entire basic range of OTCs.
Butikker der forhandler lægemidler på nettet 
Shops selling medicines online
butikker, der kun detailforhandler medicinsk udstyr. 
shops that only sell medical devices by retail.
Kort beskrivelse 
Short description
Lille film om forsøgsordningen med medicinsk cannabis 
Short film about the medicinal cannabis pilot programme
Kort nyt, side 5-6 
Short news (pp 5-6)
Kort nyt: 
Short news:
Mangel på radioaktive lægemidler i 2008/2009 samt i 2010 
Shortage of radiopharmaceuticals in 2008/2009 and into 2010.
Skal en virksomhed meddele Lægemiddelstyrelsen, hvis den kvalitetsansvarlige person ændres? 
Should a company inform the Danish Medicines Agency if a responsible person is replaced by another person?
Skal en dansk virksomhed lade sig registrere i de lande som lægemidlerne formidles i? 
Should a Danish company be registered in the countries in which the brokering activities of medicinal products take place?
Skal der indsendes dansk indlægsseddel ved ansøgning om ændringer i produktinformationen? 
Should a Danish package leaflet be submitted when applying for changes to the product information?
Bemærk, at oplysninger vedrørende samtlige punkter i bekendtgørelsen om ansøgning om tilladelse til klinisk afprøvning af medicinsk udstyr skal fremgå af afprøvningens dokumentation. 
Should a limited number of items in the executive order be considered irrelevant for a specific clinical investigation, the covering letter must contain a list of these items as well as the justification for the omissions.
Skal der indsendes en PSUR i juli for dette generiske produkt? 
Should a PSUR be submitted in July for this generic product?
Skal en leverandør auditeres? 
Should a supplier be audited?
Skal en grossist auditere transportfirmaet? 
Should a wholesale distributor audit the transportation provider?
Dette berører ikke eventuelle erstatningskrav for skade som følge af overtrædelse af andre 
should also apply where any supervisory authority concerned or the Commission requests that such matter
Ved vedvarende transaminasestigning til mere end 3 gange den øvre referenceværdi anbefales dosisreduktion eller seponering af lægemidlet. 
Should an increase in transaminases greater than 3 times the upper limit of normal persist, reduction of dose or withdrawal of the medicine is recommended.
Afslører en sådan analyse blot de mindste ændringer i pakningsmaterialet, bør virksomheden overveje, om dette kan skyldes, at lægemidlet er forfalsket. 
Should any of these tests reveal the slightest changes in the packaging material, the company should consider the possibility that the medicinal product could be falsified.
Der bør træffes enhver rimelig foranstaltning for at sikre, at personoplysninger, som 
should be established by the controller for erasure or for a periodic review.
bestemmelser i EU-retten eller medlemsstaternes nationale ret. 
should be handled in the consistency mechanism.
Skal rengøringsfirmaer og firmaer for skadedyrskontrol auditeres? 
Should cleaning companies and pest control companies be audited?
Det Europæiske Databeskyttelsesråd oprettet ved denne forordning (»Databeskyttelsesrådet«) bør kunne udstede retningslinjer i denne forbindelse. 
should have the right to have the personal data transmitted directly from one controller to another.
Skal jeg lade mig registrere som formidler, hvis jeg i forvejen har en tilladelse til engrosforhandling? 
Should I register as a broker if I have an authorisation for wholesale distribution?
udvikle indbyrdes kompatible formater, der muliggør dataportabilitet. 
should not be a refusal to provide all information to the data subject.
Bør ikke indtages af rygere". 
Should not be ingested by smokers”.
Skal parallelimportører i lighed med andre indehavere af markedsføringstilladelse indsende notifikationer/variationer i forbindelse med implementering af sikkerhedselementer? 
Should parallel importers, just like other marketing authorisation holders, submit notifications/variations in connection with the implementation of the safety features?
Skal en deltagerinformation opdateret som følge af dataforordningen (GDPR) indsendes til Lægemiddelstyrelsen? 
Should participant information that has been updated according to the General Data Protection Regulation (GDPR) be submitted to the Danish Medicines Agency?
Skal der indsendes PSUR for generiske produkter i juli 2012? 
Should PSURs be submitted for generic products in July 2012?
Skal sojalecithin (lecithin) mærkes som sojaolie? 
Should soy lecithin (lecithin) be labelled as soya bean oil?
Er det nødvendigt at vedlægge produktresumé, indlægsseddel og mærkning på dansk sammen med ansøgningen? 
Should the application include summary of product characteristics, package leaflet and labelling in Danish?
Skal det danske Case narrative bevares i sagen, selvom det kan give globale sager mindre kvalitet? 
Should the Danish case narrative appear from the case even though it may reduce the quality of global cases?
Skal Lægemiddelstyrelsen kontaktes inden, hvis Danmark er modtagerland? 
Should the Danish Health and Medicines Authority be contacted earlier if Denmark is concerned member state?
Bør dosis titreres gradvist to uger efter behandlingen? 
Should the dosage be titrated gradually two weeks after the beginning of the treatment?
Skal MAH tilsvarende sende en mail, hvis MAH ønsker at opdatere en sag, der oprindeligt er oprettet af MAH? 
Should the MAH also send an email if the MAH wants to update a case that was originally created by the MAH?
Skal den sagkyndige person angivet under ordning om én sagkyndig person på § 39-tilladelsen fortsat være angivet på virksomhedens § 39-tilladelse, selvom vedkommende ikke skriver under i frigivelsesregisteret? 
Should the qualified person named pursuant to the scheme for one qualified person on the section 39 authorisation still appear on the company's section 39 authorisation, even though that person does not sign the release register?
Skal den sagkyndige person angivet under ordning om én sagkyndig person på § 39-tilladelsen fortsat være angivet på virksomhedens § 39-tilladelse, selvom vedkommende ikke skriver under i frigivelsesregisteret? 
Should the qualified person named pursuant to the scheme for one qualified person on the section 39 authorisation still appear on the company’s section 39 authorisation, even though that person does not sign the release register?
Skal en kontraktfremstillers (/kontrakttagers) sagkyndige person tilføjes kontraktgivers § 39-tilladelse i de tilfælde, hvor kontraktgiver forlader sig på kontraktfremstillerens (/kontrakttagers) frigivelse af et mellemprodukt? 
Should the qualified person of a contract manufacturer (contract acceptor) be added to the contract giver's section 39 authorisation if the contract giver relies on the contract manufacturer's (contract acceptor's) release of an intermediate product?
Skal den sagkyndige person, der frigiver produkter til kliniske studier, angives på § 39-tilladelsen, selvom produktet aldrig frigives til salg? 
Should the qualified person releasing products for clinical trials be named on the section 39 authorisation even if the product is never released for sale?
Hvis Medicintilskudsnævnet anbefaler ændringer i lægemidlernes fremtidige tilskudsstatus til ugunst for virksomheder, der markedsfører lægemidler i disse ATC-grupper, vil der blive partshørt over nævnets indstilling. 
Should the Reimbursement Committee recommend changes to the reimbursement status of these medicines to the disadvantage of companies marketing products in the concerned ATC groups, the Committee's recommendation will be submitted for consultation to the companies.
Hvis Medicintilskudsnævnet indstiller, at tilskudsstatus for disse lægemidler bør ændres, vil vi sende nævnets indstilling i høring hos de berørte virksomheder, de relevante videnskabelige selskaber og de relevante patientforeninger. 
Should the Reimbursement Committee recommend to change the reimbursement status of these medicines, we will submit the Committee's recommendation for consultation to the affected companies, the relevant scientific societies and relevant patient organisations.
Hvis Medicintilskudsnævnet indstiller, at tilskudsstatus for disse lægemidler bør ændres, vil vi sende nævnets indstilling i høring hos de berørte virksomheder, de relevante videnskabelige selskaber og de relevante patientforeninger. 
Should the Reimbursement Committee recommend to change the reimbursement status of these medicines, we will submit the Committee’s recommendation for consultation to the affected companies, the relevant scientific societies and relevant patient organisations.
Skal den kvalitetsansvarlige hele tiden kunne kontaktes? 
Should the responsible person be continuously contactable?
Skal den kvalitetsansvarlige person være uddannet farmaceut? 
Should the responsible person hold a degree in pharmacy?
Når man ansøger et lægemiddel med særnavn, skal det aktive substansnavn så anføres i punktskrift? 
Should the substance name be stated in Braille if you apply for a medicinal product with an invented name?
Skal opdaterede indlægssedler og mærkning indsendes til Lægemiddelstyrelsen for godkendelse? 
Should updated package leaflets and labelling be submitted to the Danish Medicines Agency for approval?
om personoplysningerne var beskyttet med passende tekniske beskyttelsesforanstaltninger, der effektivt begrænser 
should use only processors providing sufficient guarantees, in particular in terms of expert knowledge, reliability
Skal Lægemiddelstyrelsen modtage ikke-alvorlige bivirkninger fra non-interventionsstudier, der er påbegyndt efter juli 2012 i overgangsperioden? 
Should we submit non-serious adverse reactions from non-interventional studies initiated after July 2012 to the Danish Medicines Agency during the transition period?
Skal Lægemiddelstyrelsen modtage indberetninger om formodede alvorlige bivirkninger, der er opstået uden for EU (tredjelande), i overgangsperioden? 
Should we submit suspected serious adverse reactions occurring outside the EU (third countries) to the Danish Medicines Agency during the transition period?
Hvis De har rettelser hertil, skal sådanne rettelser meddeles os inden den på faxen angivne frist. 
Should you have any corrections to this, please notify us before the deadline indicated on the fax.
Sibutramin 
Sibutramine
Sibutramin påvirker signalstoffer i hjernen, hvilket hæmmer appetitten. 
Sibutramine affects neurotransmitters in the brain, which suppresses appetite.
Sibutramin var tidligere godkendt til behandling af fedme, men har en række meget alvorlige bivirkninger, og al godkendt medicin med sibutramin blev trukket tilbage fra markedet i 2010. 
Sibutramine has previously been authorised for the treatment of obesity, but it also causes a number of serious side effects, and all authorised sibutramine-containing medicines were taken off the market in 2010.
Bivirkninger 
Side effects
Bivirkninger og hændelser 
Side effects and incidents
Bivirkninger og overvågning, meld en bivirkning, HPV-vaccination, biosimilære lægemidler, sikkerhedsopdateringer og sikkerhedsinformation, utilsigtede hændelser, find medicin. 
Side effects and monitoring, biosimilar medicinal products, safety updates and direct healthcare professional communication, adverse events, find medicines.
Apoteker og salg af medicin 
Side effects and product information
Bivirkninger og produktinformation 
Side effects and product information
Bivirkninger og sikkerhed ved medicinsk cannabis 
Side effects and safety of medicinal cannabis
Bivirkninger kategoriseres som alvorlige eller ikke-alvorlige. 
Side effects are categorised as serious or non-serious.
Bivirkninger ved medicin til dyr 
Side effects from veterinary medicines
Bivirkninger hos dyr 
Side effects in animals
Signaldetektion og risikohåndtering 
Signal detection and risk management
Signaler om nye mulige bivirkninger bliver sendt videre i EU-netværket til den europæiske bivirkningskomité (PRAC), hvor signalerne vurderes. 
Signals about new possible adverse reactions are forwarded in the EU system to the European Pharmacovigilance Risk Assessment Committee (PRAC), which then assesses the signal.
Signaler om nye mulige bivirkninger bliver sendt videre i EU-netværket til den europæiske bivirkningskomité (PRAC). 
Signals about new possible adverse reactions are forwarded in the EU system to the European Pharmacovigilance Risk Assessment Committee (PRAC).
nye signaler på baggrund af en række forskellige kriterier, og alle signaler på listen bliver kigget igennem. 
signals based on a number of criteria, and all signals on the list are reviewed.
recommendations on signals September samt de danske oversættelser til produktinformationen. 
signals, September as well as the Danish translations for the product information.
Underskrift(er) og virksomhedsstempel: 
Signature(s) and company stamp:
Væsentlige ændringer i mærkning og brugsanvisning 
Significant changes in labelling or instructions for use
Væsentlig påvirkning. 
Significant impairment
Antallet af deltagere, der skal indgå i forskersponserede forsøg er væsentligt højere end antallet af deltagere, der skal indgå i virksomhedssponserede. 
Significantly more trial subjects participate in trials sponsored by researchers than in trials sponsored by companies
Det kan f.eks. være kvalme, opkastning, madlede, smerter i øvre eller højre del af maven, gul hud, gule øjne eller kløe. 
Signs of impaired liver function could be nausea, vomiting, lack of appetite, upper or right belly pain, yellowing skin or eyes, or itching.
Der er sendt skilte ud med 15- og 18-årsgrænserne, som butikkerne kan sætte op til information til kunderne. 
Signs with the age limits 15 and 18 have also been sent out to shops.
tilsvarende design 
similar design
Ligesom i tidligere opgørelser beskriver de fleste af disse indberetninger formodede bivirkninger hos piger, der blev HPV-vaccineret for flere år siden. 
Similar to our previous statements, most of these ADR reports describe suspected adverse reactions in girls who had been given the HPV vaccine several years ago.
Tilsvarende i de tilfælde, hvor et vitamin/mineral leveres i "fortyndet" tilstand (typisk som en trituration eller et granulat), skal der være separat dokumentation for hhv. det rene stof og for fortyndingen. 
Similarly, in the cases where a vitamin/mineral is supplied in “diluted” form (typically as a trituration or a granulate), separate documentation must be available for the pure substance and the dilution, respectively.
Overvågning af bivirkninger er ligeledes et fortsat stærkt prioriteret indsatsområde. 
Similarly, monitoring of adverse reactions continues to be a strong priority.
Ligeledes bedes markedsføringsindehaver ikke stille spørgsmål til, hvorvidt en sag modtaget fra Patienterstatningen er en follow-up eller initial sag, men afvente at den kan downloades fra Eudravigilance-databasen. 
Similarly, the marketing authorisation holder should not ask questions as to whether a case received from the Patient Compensation Association is a follow-up or an initial case, but wait for it to be available for download from the EudraVigilance database.
Det er således heller ikke tilladt at foretage tillægsmærkning på yderpakningen, som gør opmærksom på forskellige udløbsdatoer på de indre pakninger - fx blisterkort. 
Similarly, we do not accept additional labelling on the outer packaging stating differences in the stated expiry dates on the inner packaging - e.g. blisters.
Kort fortalt, så skal der først og fremmest være nogen, der ansøger om at få deres cannabisprodukt godkendt som et lægemiddel. 
Simply put, someone first has to apply to have a cannabis product authorised as a medicine.
Samtidig med udmeldingen om organisationsændringen blev fire direktørstillinger slået op, og tre af stillingerne er nu besat. 
Simultaneously with the announcement of the new organisation, four vacant Director General positions were advertised, and three of the positions have now been filled.
Samtidig med indberetningen til Lægemiddelstyrelsen skal virksomheden informere de berørte apotekere, læger, sygeplejersker og tandlæger om indholdet af indberetningen (hvilke oplysninger, der er indberettet til Lægemiddelstyrelsen om personen). 
Simultaneously with the reporting to the Danish Medicines Agency, the company must inform the relevant proprietary pharmacists, doctors, nurses and dentists of the contents of the report (the information about the person reported to the Danish Medicines Agency).
Samtidig skal de nye regler, og den nye praksis fortsat sikre og understøtte den praktiske håndtering af lægemiddelpakningerne i distributionskæden og i sundhedssektoren”, siger lægemiddelstyrelsens direktør Thomas Senderovitz. 
Simultaneously, the new rules and the new practice will continue to secure and support the practical handling of medicine packages in the supply chain as well as in the health sector,” says Thomas Senderovitz, Director General of the Danish Medicines Agency.
Samtidig bliver bevillingen registreret i CTR - det Centrale Tilskuds Register, så apoteket kan se, at patienten har ret til at få alt sit receptordinerede medicin gratis. 
Simultaneously, the reimbursement is registered in CTR - the Central Reimbursement Register, so that pharmacies can see that the patient is entitled to be given all of his/her prescription medicine for free.
Simvastatin kan forårsage rhabdomyolyse 
Simvastatin can cause rhabdomyolysis
Sinan B. Sarac har en ph.d.-grad med titlen Benefit-Risk Assessment in Drug Development, og han har netop gennemført en Master of Science i Advanced Oncology (2014-2016) fra Universitetet i Ulm i Tyskland. 
Sinan B. Sarac holds a PhD entitled Benefit-Risk Assessment in Drug Development and recently took a Master of Science in Advanced Oncology (2014-2016) from Ulm University in Germany.
Sinan B. Sarac tiltrådte officielt som nyt medlem den 1. juli 2016. 
Sinan B. Sarac was nominated as the new member for Denmark on 1 July 2016.
Læge Sinan B. Sarac, Danmarks nye medlem af det Europæiske Lægemiddelagenturs komité for godkendelse af medicin til mennesker (CHMP) 
Sinan B. Sarac, Medical Doctor, Denmark’s new member of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)
Sinan B. Saracs ekspertiseområde ligger især inden for det onkologiske område. 
Sinan B. Sarac’s field of expertise is medical oncology.
Siden 1. januar 2016 har læger, tandlæger og jordemødre været forpligtede til så vidt muligt at oplyse lægemiddelnavn og batchnummer i bivirkningsindberetninger, der omhandler udvalgte biologiske lægemidler 
Since 1 January 2016, doctors, dentists and midwives have been obliged, as far as possible, to provide the medicine's name and batch number in ADR reports that concern selected biological medicines
Læger med en digital signatur har siden d. 1. oktober 2006 haft mulighed for at sende elektroniske ansøgninger om individuelle medicintilskud via Medicinprofilen (medicin-it.dk). 
Since 1 October 2006, doctors have been able to submit applications for individual reimbursement electronically via the Medicine Profile by means of a digital signature (medicin-it.dk).
Læger med en digital signatur har siden d. 1. oktober 2006 haft mulighed for at sende elektroniske ansøgninger om individuelle medicintilskud via Medicinprofilen . 
Since 1 October 2006, doctors have been able to submit applications for individual reimbursement electronically via the Medicine Profile by means of a digital signature.