natgillin/translations-raw huggingface dataset:
Indberetning om manglende overholdelse af GMP eller GDP hos virksomheder, som følge af inspektioner udført af europæiske lægemiddelmyndigheder 
reports of companies’ non-compliance with GMP or GDP, uncovered from company inspections carried out by European medicines agencies.
Manglende overholdelse af GMP eller GDP hos virksomheder, som følge af inspektioner udført af Lægemiddelstyrelsen eller andre europæiske lægemiddelmyndigheder 
Reports of companies’ non-compliance with GMP or GDP, uncovered from company inspections carried out by the Danish Medicines Agency or another European medicines agency.
Indberetninger om hjertemisdannelser hos børn af mødre behandlet med citalopram og sertralin under graviditeten 
Reports of heart malformations in children of mothers treated with citalopram and sertraline during pregnancy
Indberetning om produktfejl fra virksomheder og myndigheder (> 90 % af indberetningerne) 
reports of product defects from companies and authorities (> 90 % of the reports)
Indberetninger om selvmord i forbindelse med opstart af behandling med antidepressiva, side 4 
Reports of suicide correlated to initiation of antidepressants (p 4)
Indberetninger om formodede bivirkninger er en væsentligt informationskilde for at identificere mulige sikkerhedsmæssige problemer ved medicin. 
Reports of suspected adverse reactions are an important source of information and can be used to identify possible safety issues with medicines.
Indberetninger er kun formodede bivirkninger 
Reports of suspected adverse reactions only
Indberetninger om formodede bivirkninger relateret til influenzavaccine, side 8 
Reports of suspected adverse reactions related to influenza vaccine, page 8
Indberetninger om formodede bivirkninger ved influenzavaccine 
Reports of suspected adverse reactions related to influenza vaccines
ninger om formodede bivirkninger vedrørende HPV-vaccinen ikke i denne gennemgang. 
Reports of suspected adverse reactions to the HPV vaccine are therefore not included in this article.
Indberetning af formodede bivirkninger - fra indehavere af markedsføringstilladelser til lægemidler til mennesker 
Reports of suspected adverse reactions – from marketing authorisation holders of medicinal products for human use
Indberetninger om etanercept 
Reports on etanercept
Indberetning af produktfejl fra virksomheder og myndigheder (> 90 % af indberetningerne) 
Reports on product defects from companies and authorities (> 90 % of the reports)
Fordeling af indberetninger der resulterede i tilbagekaldelser i 2006-2008 
Reports resulting in withdrawals broken down by reporting source in 2006-2008
Fordeling af indberetninger der resulterede i tilbagekaldelser i 2007‐2010 
Reports resulting in withdrawals broken down by reporting source in 2007‐2010
Fordeling af indberetninger der resulterede i tilbagekaldelser i 2005-2006 
Reports resulting in withdrawals broken down by source in 2005-2006
Repræsentation af registrerede 
Representation of data subjects
REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR OPINION OF THE ETHICS COMMITTEES IN THE COMMUNITY 
REQUEST FOR AUTHORISATION OF A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND FOR THE OPINION OF THE ETHICS COMMITTEES IN THE COMMUNITY
Anmodning om start af MRP eller RUP 
Request for start-up of MRP or RUP
Request to CMD for a recommendation on the classification of an unforeseen variation under Article 5 (pdf-fil) 
Request to CMD for a recommendation on the classification of an unforeseen variation under Article 5 (PDF file)
Anmodede tilsynsmyndigheder må ikke opkræve gebyr for foranstaltninger, der træffes af dem på grundlag af en anmodning om gensidig bistand. 
Requested supervisory authorities shall not charge a fee for any action taken by them pursuant to a request for mutual assistance.
Udvekslede oplysninger må kun anvendes til det formål, som er angivet i anmodningen. 
Requests for assistance shall contain all the necessary information, including the purpose of and reasons for the request.
Anmeldelser vedrørende afregistrering skal ske via DKMAnet senest to uger før ikrafttrædelsen. 
Requests for deregistration must be submitted via DKMAnet no later than two weeks before the deregistration is to become effective.
Afmelding skal ske inden årets udgang, hvis betaling af årsafgift for det efterfølgende år skal undgås. 
Requests for termination of an authorisation must be submitted before yearend to avoid payment of the annual fee for the next year.
Anmodningen skal foretages ved at udfylde blanketten: Request for RMS in a decentralised procedure, medicinal products for human use (doc - 0,11 MB) . 
Requests should be made by filling in the form: Request for RMS in a decentralised procedure, medicinal products for human use (doc - 0,11 MB) .
Anmodningen skal foretages ved at udfylde blanketten: Request for RMS in a decentralised procedure, medicinal products for human use (doc - 0,11 MB) . 
Requests should be made by filling in the form: Request for RMS in a decentralised procedure, medicinal products for human use (doc - 0,11 MB).
Anmodninger, der ikke opfylder kriterierne ovenfor, vil blive afvist. 
Requests that do not meet the above criteria will be rejected.
bør den registrerede informeres, når personoplysningerne første gang videregives til modtageren. 
requests to be made electronically, especially where personal data are processed by electronic means.
bivirkninger, der kræver særlig opmærksomhed fremadrettet. 
require special attention in our activities ahead.
Nødvendig dokumentation 
Required documentation
Krav til modtagekontrol af virksomhedstilladelse 
Requirement to check company authorisation on receipt of medicinal products
Krav til "Blå boks" og indlægssedler - HUMANE lægemidler 
Requirements for "Blue box" and Package Leaflets - HUMAN medicinal products
Krav til "Blå boks" og indlægssedler - VETERINÆRE lægemidler 
Requirements for "Blue box" and package leaflets - VETERINARY medicinal products
Krav og forventninger til den fagkyndige person i en cannabisvirksomhed (pdf) 
Requirements for and expectations to the competent person in a cannabis company (PDF), in Danish only
Krav til medlemmerne 
Requirements for commission members
KRAV TIL MÆRKNING OG BRUGSANVISNING 
REQUIREMENTS FOR LABELLING AND INSTRUCTIONS FOR USE
Krav til mærkning og brugsanvisning 
Requirements for labelling and instructions for use
Krav til fremstilling og engrosforhandling 
Requirements for manufacturing and wholesale
Krav til alle indehavere af markedsføringtilladelser af lægemidler, der indeholder lægemiddelstoffer i form af mesilater, (di)isetionater, tosilater eller besilater 
Requirements for marketing authorisation holders for medicinal products containing active substances in the form of mesilates, (di)isetionates, tosilates or besilates
Hvilke krav skal medicinsk cannabis til forsøgsordningen overholde? 
Requirements for medicinal cannabis for the pilot programme
Krav til medlemmerne 
Requirements for members
Krav til indholdet af en bivirkningsindberetning fremgår af gennemførelsesforordningens artikel 28. 
Requirements for the contents of an adverse reaction report are laid down in Article 28 of the Implementing Regulation.
Krav til dokumentation ved ansøgning om holdbarhed 
Requirements for the documentation when applying for a storage period
Krav til de nødvendige oplysninger står beskrevet i: 
Requirements for the necessary information are described in:
Krav til resultater af bioækvivalensundersøgelser - acceptgrænser 
Requirements for the results of bioequivalence studies – acceptance limits
Der er gennemført krav om indberetning af forbrugstal vedrørende Misoprostol, der er fremstillet på apotek ligesom den årlige opfølgning på forbruget af Angusta er under forberedelse til afrapportering primo 2015. 
Requirements have been implemented as to the reporting of the consumption of Misoprostol manufactured by a pharmacy, and the annual follow-up on the consumption of Angusta is being prepared for reporting in early 2015.
Krav til medlemmerne 
Requirements of committee members
Krav til rammerne for apotekers og sygehusapotekers fremstilling af cannabisslutprodukter 
Requirements when pharmacies and hospital pharmacies prepare cannabis products
udveksling af personoplysninger i Unionen hverken indskrænkes eller forbydes af grunde, der vedrører beskyttelse 
requires that the free movement of personal data within the Union is not restricted or prohibited for reasons
forskning (deltagelse i klinisk afprøvning og test af medicinsk udstyr). 
research (participation in clinical investigations and tests of medical devices ).
forskning (deltagelse i kliniske forsøg, test og afprøvning af medicinsk udstyr samt non-interventionsforsøg). 
research (participation in clinical trials, tests and investigations of medical devices as well as non-intervention trials).
forskning (deltagelse i kliniske forsøg, test og afprøvninger af medicinsk udstyr samt non-interventionsforsøg). 
research (participation in clinical trials, tests and investigations of medical devices as well as non-intervention trials).
Forskning i biologisk materiale 
Research on biological material
Der ønskes gennemført forskningsprojekter, der kan give øget viden om brug og effekt af medicinsk cannabis. 
Research projects are requested to be carried out in order to increase our knowledge about the use and effect of medicinal cannabis.
forskning såsom deltagelse i kliniske forsøg og non-interventionsforsøg. 
research such as participation in clinical trials and non-interventional trials.
General disorders and administration site conditions 
Respiratory, thoracic and mediastinal disorders
Lidelser i luftveje, brystkasse og mellemgulv 
Respiratory, thoracic and mediastinal disorders
Ansvarsområder 
Responsibilities
Fortegnelser over behandlingsaktiviteter 
Responsibility of the controller
Ansvar for indkøb af lægemidler til landets hospitaler. 
Responsible for the procurement of medicinal products for Danish hospitals.
Begrænsning af indikationer for trimetazidin (Vastarel®), side 5 
Restricted indications for trimetazidine (Vastarel®) (p 5)
Generelt klausuleret tilskud med følgende klausul: 
Restricted reimbursement restricted to:
Indskærpelser for brugen af bromocriptin (Parlodel®) til laktationshæmning, side 3 
Restrictions on the use of bromocriptine (Parlodel®) to inhibit lactation, page 3
Begrænsning i brugen af codein til smertelindring hos børn 
Restrictions on the use of codeine for pain relief in children
Resultat af risikoanalyse og risikovurdering, herunder potentielle risici og forudsigelige alvorlige hændelser, der kan forårsages af udstyret. 
Result of risk analysis and risk assessment, including potential risks and anticipated serious adverse device effects.
Resultat (Viser 1 - 1 af 1) 
Results (Shows 1 - 1 out of 1)
resultere i betydelig eller vedvarende invaliditet eller uarbejdsdygtighed eller 
results in persistent or significant disability or incapacity, or
Resultater fra nye kliniske afprøvninger eller ny fortolkning af eksisterende data, som påvirker vurderingen 
Results of new clinical investigations or new interpretations of existing data, which affect the assessment
Undersøgelsens resultater 
Results of the study
Genoplivningsudstyr 
Resuscitation equipment
forhandling af lægemidler til behandling af gener ved rygeafvænning (§ 39 i lægemiddelloven) 
retail distribution of anti-smoking products (section 39 of the Danish Medicines Act)
salg af lægemidler til produktionsdyr uden for apotek (§ 39 i lægemiddelloven) 
retail distribution of medicinal products for production animals sold outside pharmacies (section 39 of the Danish Medicines Act)
forhandling af håndkøbslægemidler og/eller V-mærkede lægemidler uden for apotek (§ 39 i lægemiddelloven) 
retail distribution of over-the-counter and/or V-marked medicinal products sold outside pharmacies (section 39 of the Danish Medicines Act)
Detailhandlere (ekskl. håndkøbsudsalg) 
Retail distributors (excluding OTC outlets)
Detailudsalg forekommer eksempelvis i supermarkeder, materialister, tankstationer, kiosker, og dyrehandlere. 
Retail outlets are found in for example supermarkets, chemists, petrol stations, kiosks and pet shops.
Detailforhandling af lægemidler til produktionsdyr 
Retail sale of medicinal products for production animals
Detailforhandling af lægemidler 
Retail sale of medicines
Detailforhandling af ikke-apoteksforbeholdte lægemidler 
Retail sale of medicines not exclusively reserved for pharmacies
Detailforhandling af ikke-apoteksforbeholdte lægemidler uden for apotek kræver en detailforhandlertilladelse. 
Retail sale of medicines that are not exclusively reserved for pharmacies requires a retail authorisation.
Detailforhandling af håndkøbslægemidler * 
Retail sale of OTC medicines*
Detailforhandling af rygeafvænningsmidler 
Retail sale of smoking cessation products
Detailforhandlere og apoteker skal opbevare dokumentation for modtagelse og genudlevering af returnerede gasser, der er lægemidler. 
Retailers and pharmacies must keep documentation on receipt and redispensing of medical gases.
Detailforretninger skal føre et basissortiment af medicin, men på baggrund af den usædvanligt varme og langvarige sommer har Lægemiddelstyrelsen besluttet ikke at håndhæve det krav frem til den 1. september 2018. 
Retailers are required to stock a basic selection of medicines, but due to the unusually long and hot summer, the Danish Medicines Agency has decided not to enforce the requirement until 1 September 2018.
Detailforhandlere gennemgår i stedet forud for deres godkendelse et e-læringsmodul om reglerne på området. 
Retailers complete an e-learning module about the rules in this field before they are granted authorisation.
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