natgillin/translations-raw huggingface dataset:
Tilbagevirkende kraft
Retrospective effect
Retsinformation.dk: Bekendtgørelse af dyreværnsloven
Retsinformation.dk: Danish Animal Welfare Act (in Danish only)
Returlægemidler
Returned medicinal products
Returneringer og tilbagetrækninger
Returns and recalls
Revatio (sildenafil) er godkendt i EU til behandling af børn, men bør kun bruges i de anbefalede lave doser, side 4
Revatio (sildenafil) has been approved in the EU for the treatment of children, but should only be used in the recommended low doses (p 4)
Gennemgang og vurdering af de alvorlige indberetninger I vurderingen af de alvorlige indberetninger skønnes, om der kan være en sammenhæng med vaccinen.
Review and assessment of the serious ADR reports When we assess the serious ADR reports, we consider if it is likely that there is a causal link to the vaccine.
Afgørelse om generelt tilskud til Multaq®
Review concluded regarding general reimbursement for Multaq®
Behandling af ansøgninger om godkendelse af medicin
Review of applications for authorisation of medicines
Undersøgelse af medicin, der indeholder zolpidem
Review of medicines containing zolpidem
Gennemgang af andre EU-retsakter om databeskyttelse
Review of other Union legal acts on data protection
Gennemgang af Heparin sagen
Review of the Heparin case
Gennemgang af de ikke alvorlige
Review of the non-serious ADR reports
IgG positiv, PCR positiv for mor
Review of the reports classified as serious
Gennemgang af Vivaglobin® afsluttet, side 5
Review of Vivaglobin® completed (p 5)
at gennemgå nyeste indlægsseddel eller produktresumé og opdatere afdelingernes instrukser i henhold til den gældende produktinformation
review the newest package leaflet or summary of product characteristics and update the department's instructions according to the current product information
Reviderede udgaver skal kun indsendes til vurdering, hvis ændringerne har betydning for igangværende forsøg, eller hvis dette sker i forbindelse med ansøgning af nye forsøg.
Revised versions should only be submitted for assessment if the changes are significant to ongoing trials or if it occurs in connection with an application for new trials.
En omskrivning af fx reklamematerialet vil ikke ændre på det reelle formål med produktet.
Rewriting the advertising material, etc. will not change the intended purpose of the product.
Rhabdomyolyse og anden alvorlig påvirkning af skeletmuskulaturen er især set ved doser over 20 mg. Nyrepåvirkning er ligeledes oftere indberettet som formodet bivirkning ved den højeste dosis på 40 mg. Specialistovervågning anbefales, når doser på 40 mg påbegyndes.
Rhabdomyolysis and other serious effects on skeletal muscle have in particular been seen with doses higher than 20 mg. Renal impairment has been observed as a suspected adverse reaction in particular with the highest dose of 40 mg. Specialist supervision is recommended when the 40 mg dose is initiated.
Riboflavinnatriumphosphat 1,27
Riboflavin sodium phosphate 1.27
Adgang til effektive retsmidler over for en dataansvarlig eller databehandler
Right to an effective judicial remedy against a controller or processor
Adgang til effektive retsmidler over for en tilsynsmyndighed
Right to an effective judicial remedy against a supervisory authority
Ret til erstatning og erstatningsansvar
Right to compensation and liability
Ret til at indgive klage til en tilsynsmyndighed
Right to lodge a complaint with a supervisory authority
Den Europæiske Unions Tidende
Right to rectification
Ordningen, der er omhandlet i stk.
Right to restriction of processing
Højreklik på ”Hent", og vælg ”Gem destination som”, og gem skabelonen på din computer.
Right-click ”Download", and select ”Save destination as”, and save the template on your PC.
undtagelser i særlige situationer, er opfyldt.
rights and freedoms of natural persons.
forordning, herunder beføjelsen til at forbyde behandlingsaktiviteter.
rights, discrimination, identity theft or fraud, financial loss, unauthorised reversal of pseudonymisation, damage
Rimonabant kom på markedet august 2006 og medførte dengang en stor stigning (94,5 %) i antallet af ansøgninger om enkelttilskud til fedmemidler i forhold til i 2005.
Rimonabant was marketed in August 2006 and prompted a massive increase (94.5%) in the number of applications for single reimbursement of weight loss products compared with 2005.
Baggrunden for dette var, at EMEA i oktober 2008 kom med udmeldingen om, at rimonabant ville få suspenderet sin markedsføringstilladelse pga. en øget risiko for psykiatriske bivirkninger – især depression.
Rimonabant was withdrawn when EMA reported, in October 2008, that the marketing authorisation for rimonabant would be suspended due to the risk of psychiatric side effects - including depression.
Baggrunden for dette var, at EMEA i oktober 2008 kom med udmeldingen om, at rimonabant ville få suspenderet sin markedsføringstilladelse pga en øget risiko for psykiatriske bivirkninger - især depression.
Rimonabant was withdrawn when EMEA reported, in October 2008, that the marketing authorisation for rimonabant would be suspended due to the risk of psychiatric side effects - including depression.
Baggrunden for dette var, at EMEA i oktober 2008 kom med udmeldingen om, at rimonabant ville få suspenderet sin markedsføringstilladelse pga en øget risiko for psykiatriske bivirkninger – især depression.
Rimonabant was withdrawn when EMEA reported, in October 2008, that the marketing authorisation for rimonabant would be suspended due to the risk of psychiatric side effects - including depression.
Risedronat og risiko for spiserørskræft (pdf-fil)
Risedronate and the risk of oesophageal cancer (PDF file in Danish)
Risikoanalyse var en væsentlig mangel blandt de inspicerede dentallaboratorier og gav anledning til flere afvigelser.
Risk analysis was a major deficiency among the inspected dental laboratories and this gave rise to several deviations.
Risikofaktorer for udvikling af osteoporotisk fraktur
Risk factors for development of osteoporotic fracture
Risiko for alvorlige allopurinolinducerede kutane bivirkninger - forbindelse til patienter der bærer HLA-B 5801 allel (pdf-fil)
Risk of allopurinol-induced serious cutaneous adverse reactions – association in patients who are carriers of the HLA-B*5801 allele (PDF file in Danish)
Risiko for blodpropper ved brug af hormonal prævention, side 8
Risk of blood clots associated with hormonal contraceptives (p 8)
Risiko for blodpropper ved cancermedicinen ponatinib (Iclusig®)
Risk of blood clots from the use of the cancer medicine ponatinib (Iclusig®)
Risiko for central serøs chorioretinopati ved glukokortikoidbehandling, side 8
Risk of central serous chorioretinopathy in glucocorticoid treatment, page 8
Risiko for depression ved brug af gonadotropin-releasing hormone (GnRH)-agonister, side 4
Risk of depression from gonatropin-releasing hormone (GnRH) agonists, page 4
Risiko for femurfraktur ved behandling med Prolia® (denosumab), side 2
Risk of femoral fracture during treatment with Prolia® (denosumab) (p 2)
Risiko for hypermagnesiæmi ved parenterale ernæringspræparater Numeta G13E og G16E
Risk of hypermagnesaemia from the use of the parenteral nutrition preparations Numeta G13E and G16E
Risiko for migration af etonogestrel-implantater (Implanon/ Implanon NXT/Nexplanon)
Risk of migration of etonogestrel implants (Implanon/ Implanon NXT/Nexplanon)
Risiko for anden hæmatologisk primær malignitet hos patienter i behandling med thalidomid (Thalidomide Celgene®), side 8
Risk of other haematological primary malignancies in patients undergoing treatment with thalidomide (Thalidomide Celgene®) (p 8)
Risiko for overdosering med intravenøs paracetamol (Perfalgan®), side 2
Risk of overdose of intravenous paracetamol (Perfalgan®) (p 2)
Gilenya (fingolimod) – øget monitorering af hjerterytme og blodtryk ved initiering af behandling (forsiden)
Risk of overdose with methotrexate in the treatment of rheumatoid arthritis and psoriasis (front page)
Risiko for alvorlige bivirkninger
Risk of serious side effects
Risiko for tromboemboli eller død efter afbrydelse af AK-behandling hos patienter med atrieflimren (side 4-5)
Risk of thromboembolism or death after discontinuation of anticoagulant therapy in patients with atrial fibrillation (pp 4-5)
Risiko for venøs tromboemboli ved brug af 4. generations p-piller (Yasmin® m.fl.) (side 6)
Risk of venous thromboembolism from the use of 4th generation contraceptive pills (Yasmin® etc.) (p 6)
Risiko for venøse thromboembolier ved brug af Yasmin® – opfølgning
Risk of venous thromboembolism from the use of Yasmin® – follow-up
Risiko for indhold af virus i blodplasma til lægemiddelfremstilling
Risk of virus content in blood plasma for the manufacture of medicinal products
Der er tale om følgende vejledninger:
Risk proportionate approaches in clinical trials
Risikobaseret tilgang i kliniske forsøg
Risk proportionate approaches in clinical trials
Risikotilpasset sagsbehandling af kliniske forsøg med markedsførte lægemidler (type A forsøg)
Risk-adapted assessment of clinical trials of already marketed medicinal products (Type A trials)
Risikobaseret bivirkningsovervågning
Risk-based pharmacovigilance
Risikobaseret planlægning og udførelse af kontrol
Risk-based planning and performance of control
Risikobaseret planlægning og udførelse af kontrol I perioden 2007-2008 gennemførte Lægemiddelstyrelsen tre pilotprojekter om risikostyring.
Risk-based planning and performance of control During 2007-2008, the Danish Medicines Agency successfully completed three pilot projects on the topic of risk management.
Risici ved off-label behandling med NeuroBloc® (botulismetoksin type B), side 5
Risks associated with off-label use of NeuroBloc® (botulinum toxin type B) (p 5)
Risikobaseret sagsbehandling muliggjort
Risk‐adapted assessment now a possibility
Rituximab (MabThera®) og alvorlige hudreaktioner, side 7
Rituximab (MabThera®) and severe skin reactions (p 7)
RMP-skemaer eller skemaer med målrettede spørgsmål skal fremsendes via Eudralink i Word-format til adr@dkma.dk.
RMP forms or forms with specific questions should be submitted via Eudralink in Word format to adr@dkma.dk
RMP-skemaer skal stadig fremsendes via Eudralink til ADR@dkma.dk.
RMP forms should still be submitted via Eudralink to ADR@dkma.dk.
Rosuvastatin og risiko for gynækomasti (pdf-fil)
Rosuvastatin and risk of gynaecomastia (PDF file in Danish)
Rosuvastatin og risiko for gynaecomasti, side 3
Rosuvastatin and the risk of gynaecomastia, page 3
Rotarix og RotaTeq® og risiko for intussusception
Rotarix and RotaTeq® and risk of intussusception
Der skal ikke indsendes rutinemæssige periodiske sikkerhedsopdateringer for følgende lægemidler:
Routine periodic safety update reports are not required for the following medicinal products:
Rudolf Albert Scheller, speciallæge i intern medicin og geriatri
Rudolf Albert Scheller, specialist in internal medicine and geriatrics
Regler om cannabis
Rules about cannabis
European Commission - EU logo for online sale of medicines
Rules about pharmacies' and authorised retailers' online sale of medicines
Regler om apotekers og godkendte detailforhandleres onlinesalg af medicin
Rules about pharmacies' and authorised retailers' online sale of medicines
Regler om tilknytning for virksomheder omfattet af forsøgsordning
Rules about relationships applicable to companies comprised by the pilot programme
Regler om tilknytning for virksomheder
Rules about relationships to companies
Regler og vejledning
Rules and guidelines
Regler og love
Rules and legislation
Love og regler for Sundheds- og Ældreministeriet på retsinformation.dk
Rules and legislation for the Danish Ministry of Health at retsinformation.dk (in Danish)
Love og regler for Sundheds- og Ældreministeriet på retsinformation.dk - november 2011 og tidligere
Rules and legislation for the Danish Ministry of Health at retsinformation.dk - November 2011 and before (in Danish)
Regler for aktive stoffer (API)
Rules applicable to active substances (APIs)
b) regler for ledsagende behandling/medicinering før og/eller under forsøget (inkl. "rescue medicine"),
Rules for concomitant treatment/medication before and/or during the trial (including "rescue medicine")
Regler for produktion, import, salg, udlevering og brug af medicin til dyr
Rules governing manufacturing, importation, distribution, dispensing and use of veterinary medicines
Regler for privates køb af medicin i udlandet
Rules governing private individuals' purchases of medicines abroad
Forretningsorden
Rules of procedure
Regler for tilknytning i forbindelse med deltagelse i paneldebatter
Rules on relationships in connection with participation in panel debates
Regler for tilknytning ved deltagelse i paneldebatter
Rules on relationships in connection with participation in panel debates
REGLER:
RULES:
RUP (Repeat Use Procedure) For ansøgninger om markedsføringstilladelser i andre EU/EØS-lande gennem den gensidige anerkendelsesprocedure (MRP), og hvor Danmark har rollen som referenceland (RMS) er der følgende gebyrer:
RUP (Repeat Use Procedure) Applications for marketing authorisations in other EU/EEA countries through the mutual recognition procedure (MRP) with Denmark as Reference Member State (RMS) are subject to the following fees:
RUP straks efter afsluttet DCP/MRP
RUP immediately after completed DCP/MRP
Pose/brev: Lille pose af vævet papir eller kunststof (som tepose), indeholdende enkeltdosis lægemiddel.
Sachet/bag: Small sachet of woven paper or synthetic material (such as a tea bag), containing a single dose of the medicine.
Vi har desværre eksempler på, at ulovlig medicin bliver lavet under uhygiejniske forhold og indeholder andet end det, der står på etiketten.
Sadly, there are many examples of illegal medicines being manufactured under unhygienic conditions and containing anything but what is on the label.
Garantier og undtagelser i forbindelse med behandling til arkivformål i samfundets interesse, til videnskabelige eller historiske forskningsformål eller til statistiske formål
Safeguards and derogations relating to processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes
udpege den tilsynsmyndighed, der fungerer som fælles kontaktpunkt for disse myndigheders effektive deltagelse i
safeguards may consist of making use of binding corporate rules, standard data protection clauses adopted by the
Overvågning af sikkerheden i forbindelse med ændring fra Gardasil® til Cervarix® som HPV-vaccine i børnevaccinationsprogrammet, side 3
Safety monitoring following switch from Gardasil® to Cervarix® as HPV vaccine in the childhood immunisation programme, page 3
Sikkerheden ved botulinumtoksin (Botox® m.fl.) og fillers til kosmetisk behandling, side 6
Safety of products containing botulinum toxin (Botox® etc.) and fillers for cosmetic treatment, page 6
sikkerhedsprocedurer, fx komitéer.
safety procedures, e.g. committees.
Overvågning af godkendt klinisk forsøg
Safety surveillance of authorised clinical trial
Sikkerhedsopdateringsrapporter
Safety update reports
Safetyvariationer er ikke blevet indsendt indenfor acceptable tidsfrister
Safety variations were not submitted within the acceptable deadlines
Salg af medicin uden for apotek
Sale of medicine outside pharmacies
Forhandling af lægemidler fra
Sale of medicines from pharmacies
Forhandling af lægemidler fra apotek
Sale of medicines from pharmacies
Salg af medicin uden for apotek
Sale of medicines outside pharmacies
Salg af håndkøbslægemidler via internettet
Sale of OTC medicines online
Salg eller udlevering af medicin kræver en markedsføringstilladelse
Sale or dispensing of medicine requires a marketing authorisation
Salg/oplagring af gasser til medicinsk brug beregnet til salg/distribution direkte til forbrugeren/patienten kræver detailtilladelse (jf. § 4 i bekendtgørelse nr. 1318 af 27. november 2007, om gasser til medicinsk brug).
Sale/storage of medical gases intended for sale/distribution directly to the consumer/patient requires an authorisation for retail sale (cf. section 4 of executive order no. 1318 of 27 November 2007 on medical gases).
Salget sker ofte over nettet og på tværs af landegrænser.
Sales often take place over the internet and across geographical borders.
Salgssteder i alt
Sales outlets in total
samme materialer i kontakt med væv eller kropsvæsker
same materials in contact with tissue or body fluids
Samme formodede risiko som for paroxetin
Same risk as suspected for paroxetine
Sara har bred erfaring med politikudvikling, EU-regulering og implementering i dansk lovgivning samt EU- og internationalt samarbejde.
Sara has extensive experience with policy development, EU regulation and implementation into Danish law and with EU and international collaboration.
Sara har tidligere arbejdet i bl.a. Udlændinge- og Integrationsministeriet, Undervisningsministeriet og Miljø- og Fødevareministeriet.
Sara has previously worked in the Ministry of Immigration and Integration, the Ministry of Education and the Ministry of Environment and Food of Denmark.
Sara Westengaard Guldagger tiltrådte som enhedschef for det nye ledelsessekretariat den 1. august 2018.
Sara Westengaard Guldagger joined as Director of Division of the new Directors’ Office on 1 August 2018.
Tilfredsstillende Ikke tilfredsstillende
Satisfactory Unsatisfactor y
Tilfredsstillende/ Mindre tilfredsstillende
Satisfactory/ Less satisfactory
Sativex indeholder cannabisekstrakter og er et godkendt lægemiddel i Danmark.
Sativex contains cannabis extracts and is an authorised medicine in Denmark.
Sativex indeholder cannabisekstrakter og kan udskrives af speciallæger i neurologi til patienter med multipel sklerose.
Sativex contains cannabis extracts and may be prescribed by neurologists to patients with multiple sclerosis.
Sativex har været igennem den officielle godkendelsesproces og er derfor blevet testet i kontrollerede laboratorieforsøg, dyreforsøg og menneskeforsøg.
Sativex has gone through the official authorisation procedure, which means it has been tested in controlled laboratory trials, animal trials and human trials.
Sativex bliver lavet af lægemiddelvirksomheden GW Pharmaceuticals, som også forsker i andre typer lægemidler baseret på cannabis.
Sativex is manufactured by GW Pharmaceuticals, a pharmaceutical company that carries out research with other types of cannabis-based medicines as well.
Det er en mundhulespray baseret på et ekstrakt af cannabis.
Sativex® is an oromucosal spray based on an extract of cannabis.
Gem formularens indhold på egen harddisk
Save the form's contents on your hard drive
Gem formularens indhold på egen harddisk
Save the form’s contents on your hard drive
om databeskyttelse vedtaget af en tilsynsmyndighed eller kontraktbestemmelser godkendt af en tilsynsmyndighed.
scale of special categories of personal data and data relating to criminal convictions and offences, a person with
Skan af prøvepakning (ydre og indre emballage) fra eksportlandet, påført ansøgerens navn, dato for ansøgning samt eksportland.
Scanned images of the specimen package (inner and outer packaging) from the export country, bearing the name of the applicant, date of application and name of export country.
Bilag 1 til bekendtgørelsen om euforiserende stoffer nr. 557 af 31. maj 2011 angiver nummeret på stoffet samt stoffets navn.
Schedule 1 to the executive order no. 557 of 31 May 2011 on euphoriant substances shows the name and number of the individual substances.
Ordning om én sagkyndig person på § 39-tilladelsen
Scheme for one qualified person authorised and listed on the section 39 authorisation.
Ordning om flere sagkyndige personer på § 39-tilladelsen
Scheme for several qualified persons authorised and listed on the section 39 authorisation
Ordning om flere sagkyndige personer på § 39-tilladelsen
Scheme for several qualified persons authorised and listed on the section 39 authorisation.
Schroll Medical ApS (tilladelse sendt 12. april 2018)
Schroll Medical ApS (authorisation sent 12 April 2018)
Scientific advice-procedurer.
Scientific advice procedures.
Videnskabelig rådgivning skal fremme forskning og innovation
Scientific advice to promote research and innovation
Videnskabelig vurdering af fordele og ulemper
Scientific evaluation of the benefit-risk balance
Der er videnskabelig evidens for, at ældre p-pille-typer, som også kaldes 2. generations p-piller, giver lavere risiko for blodpropper end de nyere typer (3. og 4. generations p-piller).
Scientific evidence shows that the older 2nd generation contraceptive pills are associated with a lower risk of blood clots compared to the newer 3rd and 4th generation contraceptive pills.
En videnskabelig betegnelse efterfulgt af et varemærke eller navnet på indehaveren af markedsføringstilladelsen
Scientific name followed by a trademark or the name of the marketing authorisation holder
Videnskabelig betegnelse efterfulgt af et varemærke eller navnet på indehaveren af markedsføringstilladelsen
Scientific name followed by a trademark or the name of the marketing authorisation holder
sletning eller tilintetgørelse
scientific research purpose.
Videnskabelige selskaber og patientforeninger er orienteret.
Scientific societies and patient organisations have been informed.
lovovertrædelser, og sandsynligvis ikke indebærer en risiko for fysiske personers rettigheder og frihedsrettigheder
scope, context and purposes of the processing and the risk to the rights and freedoms of natural persons.
Scope, field of application, definition (formål)
Scope, field of application, definition
Scopoderm®-depotplastre og synsforstyrrelser, side 5
Scopoderm® transdermal patches and visual disturbances, page 5
Du kan se billeder af produkterne og pakningerne længere nede.
Scroll down to see images of the products and packages.
Søgning - giver mulighed for at søge på lægemiddel, virksomt stof og/eller varenummer.
Search - this part enables you to search for a medicinal product, an active substance and/or a product number.
Søg i lister over omfattede virksomheder
Search lists of companies involved
Søgemuligheder (filtre)
Search options (filters)
Søgning i EudraGMDP databasen
Search the EudraGMDP database
Søg i liste over omfattede virksomheder
Search the list of companies involved
Søg i liste over tandlæger med tilknytning til virksomheder
Search the list of dentists who have a relationship with a company
Søg i liste over læger med tilknytning til virksomheder
Search the list of doctors who have a relationship with a company
Søg i liste over sygeplejersker med tilknytning til virksomheder
Search the list of nurses who have a relationship with a company
Søg i liste over personer, der modtager økonomisk støtte
Search the list of persons who receive financial support
Sekundær dataindsamling af bivirkninger fra non-interventionsstudier skal ikke indsendes løbende til Lægemiddelstyrelsen, men kun indgå i den endelige studierapport.
Secondary data collection of adverse reactions from non-interventional studies should not be submitted to the Danish Medicines Agency on an ongoing basis.
Sekundær profylakse af iskæmisk hjertesygdom, TCI/iskæmisk cerebralt insult, perifer arteriel insufficiens samt til diabetespatienter (alle med total-kolesterol over 3,5 mmol/l efter livsstilsændring).
Secondary prevention of ischaemic heart disease, TIA/ischaemic stroke, peripheral arterial insufficiency and diabetic patients (all patient categories with a total cholesterol level above 3.5 mmol/L after lifestyle changes).
For det andet kræver vurderingen af klinisk betydning mere nuancerede overvejelser og inddragelse af relevant lægelig ekspertise.
Secondly, assessment of clinical significance requires considerations that are more varied and the involvement of relevant medical expertise.
For det andet, kan der være forhold som gør, at et cannabismellemprodukt i en periode ikke er tilgængeligt, fx hvis der opstår leveringsproblemer hos fremstilleren.
Secondly, conditions could make a cannabis intermediate product unavailable for a period of time, for example if the manufacturer is faced with supply difficulties.
For det andet kan der selv ved 'rigtige' doser være bivirkninger, der kræver lægelig overvågning og evt. indgriben.
Secondly, even at ‘right' doses, side effects requiring medical supervision and possibly intervention could occur.