natgillin/translations-raw huggingface dataset:
Alvorlige bivirkninger skal indberettes til Lægemiddelstyrelsen senest 15 dage efter, at lægen har fået formodning herom.
Serious adverse reactions must be reported to us no later than 15 days after the doctor became aware of an occurrence.
alvorlig hændelse eller alvorlig bivirkning: en hændelse eller bivirkning, som uanset dosis resulterer i død, er livstruende, medfører hospitalsindlæggelse eller forlængelse af hospitalsophold, resulterer i betydelig eller vedvarende invaliditet eller uarbejdsdygtighed eller fører til en medfødt anomali eller misdannelse.
Serious event or serious adverse reaction: any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.
Alvorlige forsyningsvanskeligheder for lægemidler
Serious medicine supply difficulties
Situationer med alvorlige forsyningsvanskeligheder kan f.eks. opstå når indehaveren af en markedsføringstilladelse har leveringsvanskeligheder, eller når der er problemer med et lægemiddels kvalitet, sikkerhed eller effekt.
Serious medicine supply difficulties can occur if the marketing authorisation holder is having delivery problems or if there are any problems relating to the quality, safety or efficacy of a medicinal product.
Alvorlige forsyningsvanskeligheder defineres som tilfælde, hvor en mangelsituation vil påvirke behandlingen af patienter.
Serious medicine supply difficulties mean a short supply situation, which will affect the treatment of patients.
Alvorlige afvigelser
Serious non-compliance
Alvorlige indberetninger er defineret som, at tilstanden er dødelig, livstruende, kræver hospitalsindlæggelse eller lignende.
Serious reports are defined as a condition that results in death, is life-threatening, requires hospitalisation or the like.
Alvorlig risiko for for teratogenicitet ved brug af mycophenolat mofetil - ny vejledning om svangerskabsforebyggelse hos kvinder og mænd
Serious risk of teratogenicity from the use of mycophenolate mofetil - new important contraception guidelines for men and women
Alvorlig risiko for teratogenicitet ved brug af mycophenolat mofetil - ny vigtig vejledning om svangerskabsforebyggelse hos kvinder og mænd
Serious risk of teratogenicity from the use of mycophenolate mofetil - new important contraception guidelines for men and women
Alvorlig risiko for for teratogenicitet ved brug af mycophenolat mofetil – ny vejledning om svangerskabsforebyggelse hos kvinder og mænd
Serious risk of teratogenicity from the use of mycophenolate mofetil – new important contraception guidelines for men and women
Serologisk testning på blodprøver er påvisning af antistof/antigen, mens NAT testning er detektion af DNA/RNA fra virus vha. nukleinsyre amplifikationsteknologi.
Serological testing of blood samples is the demonstration of antibody/antigen, whereas NAT testing is the detection of DNA/RNA from virus by means of the nucleic acid amplification technique.
Sertidol, ziprazidon, asenapin og palperidon og indberetninger om dødsfald
Sertindole, ziprasidone, asenapine and paliperidone and reports of deaths
Serviceaftale med skadedyrskontrolfirma
Service agreement with pest control company
kategorier af personoplysninger om helbredsforhold for så vidt angår specifikke behov, navnlig hvis behandlingen
services, especially in order to ensure the quality and cost-effectiveness of the procedures used for settling claims
Her er syv vigtige ting, du skal vide:
Seven important things to know:
Syv vævscentre håndterer udelukkende sæd til IUI-behandlinger.
Seven tissue establishments exclusively handle sperm for IUI treatment.
Der er set flere utilsigtede hændelser relateret til ordination og administrering af smerteplastrene.
Several adverse incidents have occurred in relation to prescription and administration of the pain-relief patches.
Flere sager har resulteret i ændringer til mærkning og emballage, som har øget patientsikkerheden.
Several cases have resulted in changes to labelling and packaging material, thereby improving patient safety.
Flere lande kræver en engrosforhandlertilladelse for denne aktivitet.
Several countries require a Wholesale Distribution Authorisation for this activity.
Der foreligger en række EU-guidelines vedr. kliniske forsøg generelt samt specifikke guidelines for nogle terapeutiske grupper.
Several EU guidelines exist on clinical trials in general as well as specific guidelines for certain therapeutic groups.
Der kan findes flere forklaringer på denne udvikling, men en væsentlig faktor for stigningen har været de seneste års skærpede fokus på bivirkningsindberetning generelt.
Several factors may explain this development, but one significant cause of the increased reporting is the past years' enhanced focus on reporting of side effects.
Flere af ovennævnte lægemidler er omtalt eller anbefalet i kliniske vejledninger som fx Lægemiddelstyrelsens referenceprogrammer og DSAM’s kliniske vejledninger for unipolar depression og angstlidelser samt i den Nationale Rekommandationsliste, og nævnet har derfor anbefalet at medtage disse lægemidler i revurderingen.
Several of the above-listed medicines are mentioned or recommended in clinical guidelines such as the Danish National Board of Health's clinical guidelines and the Danish College of General Practitioners' guidelines for unipolar depression and anxiety disorders as well as in the National Recommendation List.
Flere af lægemidlerne i ATC-gruppe N06A er også godkendt til behandling af angstlidelser.
Several of the medicines in ATC group N06A are also authorised for the treatment of anxiety disorders.
Flere af de videnskabelige selskaber understreger, at patienten skal have adgang til den bedst mulige relevante behandling, og Dansk Hypertensionsselskab har foreslået, at det burde være udgiftsneutralt for patienten, om denne behandles med et eller flere lægemiddelstoffer.
Several of the scientific societies emphasise that the patient should have access to the best possible relevant treatment, and the Danish Hypertension Society has proposed that it should be cost-neutral for the patient whether he or she is treated with one or more active substances.
Flere høringsparter kritiserer, at sammenligninger af lægemidler i revurderingsprocessen ikke tager udgangspunkt i lægemidlernes godkendte indikationer, som forudsætter en omfattende og omkostningstung dokumentation.
Several parties to the consultation criticise the fact that comparisons between medicinal products in the reassessment process are not based on the approved indications of the medicinal products, which require comprehensive and expensive documentation.
Der har fra flere høringsparter været fremsat forslag om, at eventuelle ændringer i de hjertekarlægemidlernes tilskudsstatus kun skal gælde fremadrettet - dvs. for nye patienter, der sættes i behandling efter en given dato, men at lægemidlets ”gamle tilskudsstatus” bevares for patienter, der allerede er i behandling.
Several parties to the consultation have proposed that any changes in the reimbursement status of the cardiovascular products should only apply in future - i.e. for new patients for whom treatment is initiated after a given date - but that the ‘old reimbursement status' of the medicinal product should be maintained for patients already undergoing treatment.
Det har fra flere høringsparter været fremført, at angiotensin-II antagonisten Cozaar er på vej af patent.
Several parties to the consultation have stated that the angiotensin II antagonist Cozaar is coming off patent.
Flere høringsparter påpeger, at compliance i forbindelse med præparatskift er et væsentligt problem.
Several parties to the consultation point out that compliance in connection with a change of product constitutes an important problem.
Flere høringsparter anbefaler, at der ikke sker ændringer i etableret behandling.
Several parties to the consultation recommend that no changes be made to the established therapy.
Flere høringsparter anfører, at losartan ikke har samme dokumentation som de øvrige angiotensin-II antagonister, herunder for hjerteinsufficiens, hvor valsartan og candesartan fremhæves.
Several parties to the consultation state that losartan has not been documented to the same extent as the other angiotensin II antagonists, including for heart insufficiency, in respect of which valsartan and candesartan are particularly noteworthy.
Flere høringsparter skriver, at Medicintilskudsnævnet eksplicit bør redegøre for forventede compliancemæssige problemer ved en generel anbefaling om behandlingsskifte og henviser til, at mellem 5 % og 20 % af patienterne får bivirkninger i form af irritationshoste ved anvendelse af ACE-hæmmere.
Several parties to the consultation state that the Reimbursement Committee should explicitly account for the expected compliance problems in case of a general recommendation of change of treatment, and they make reference to the fact that between 5 and 20 per cent of the patients experience adverse reactions in the form of irritated cough when using ACE inhibitors.
Flere høringsparter peger på, at Lægemiddelstyrelsen skal være opmærksom på den praktiske implementering af de kommende ændringer.
Several parties to the consultations point to the fact that the Danish Medicines Agency must pay attention to the practical implementation of future changes.
Flere høringsparter efterlyser en sundhedsøkonomisk analyse af de foreslåede ændringer og efterlyser, at Medicintilskudsnævnet redegør for de forventede meromkostninger for det offentlige og patienterne samt det forventede ressourcetræk på lægerne ved en generel anbefaling om behandlingsskift.
Several parties to the consultations request a health economic analysis of the proposed changes and request that the Reimbursement Committee account for the expected additional costs for the public sector and patients as well as for the expected resource demand for doctors in case of a general recommendation of change of treatment.
Flere patienter med formodede bivirkninger efter HPV-vaccinen er blevet henvist for nærmere udredning på Synkopecenteret.
Several patients experiencing suspected adverse reactions to the HPV vaccine have been referred to the Syncope Centre for further screening.
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?