natgillin/translations-raw huggingface dataset:
Herudover er det vigtigt, at der er et beredskab af lægemidler, som kan imødekomme borgernes behov for lægemidler i særlige krisesituationer. 
In addition, it is important to have a ready supply of medicines that meet citizens' needs for medicines in special crisis situations.
Hertil kommer, at en lavere udgift til behandlingen efter et præparatskifte kan tænkes at bedre patientens compliance. 
In addition, it is likely that lower treatment expenses resulting from a change of product will improve the patient's compliance.
Hertil kommer, at en lavere udgift til behandlingen efter et præparatskifte kan tænkes at bedre patientens compliance. 
In addition, it is likely that lower treatment expenses resulting from a product switch will improve the patient's compliance.
Derudover er det også muligt at lave filtreringer på indberetninger fra sundhedspersonale og indberetninger fra patienter og pårørende. 
In addition, it is possible to search for reports submitted by healthcare professionals as well as patients and relatives.
Derudover anvendes det til eradikationsbehandling af Helicobacter pylori i kombination med syrehæmmende behandling. 
In addition, it is used for eradication treatment of Helicobacter pylory in combination with antacid treatment.
Desuden bør dosering som ugentlig tydeligt fremgå. 
In addition, it must appear clearly if the specified dose is 'weekly'.
Medicinen skal desuden kunne sælges lovligt til privatpersoner i det land hvor det er købt og skal være til personlig brug til sygdomsforebyggelse eller -behandling af mennesker. 
In addition, it must be legal to sell the medicine to private individuals in the country where it was bought and must be for personal use as part of disease prevention or treatment of humans.
Medicinen skal desuden kunne sælges lovligt til privatpersoner i det land hvor det er købt og skal være til personlig brug til sygdomsforebyggelse eller –behandling af mennesker. 
In addition, it must be legal to sell the medicine to private individuals in the country where it was bought and must be for personal use as part of disease prevention or treatment of humans.
Det vil desuden være hensigtsmæssigt at have fokus på tiltag, der kan afsløre eller indikere, om uvedkommende har haft adgang til eksempelvis transportbeholdere med lægemidler. 
In addition, it would be appropriate to focus on measures that can reveal and signal if unauthorised persons may have had access to e.g. transport containers with medicinal products.
Endvidere er det i pkt. 4.9.1 og 4.9.2 angivet, at investigator skal sikre, at data, der rapporteres til sponsor, er præcise, komplette, læsbare og formålstjenlige og konsistente med kildedata. 
In addition, items 4.9.1 and 4.9.2 indicate that the investigator should ensure the accuracy, completeness, legibility and timeliness of the data reported to the sponsor and that the data reported should be consistent with the source documents.
Desuden ansvarlig for medicinsk udstyr, herunder godkendelse af kliniske forsøg med medicinsk udstyr og markeds overvågning. 
In addition, Jens Piero Quartarolo is responsible for medical devices, including the authorisation of clinical trials involving medical devices and market surveillance.
Derudover omfatter medicinsk udstyr handicaphjælpemidler som kørestole, lifte og krykker samt svangerskabsforebyggende midler som kondomer og spiraler. 
In addition, medical devices cover aids for the disabled, such as wheelchairs, hoists and crutches as well as contraceptives like condoms and intrauterine devices.
Der kommer desuden krav om, at medicinsk udstyr skal have et unikt identifikationsnummer, så produktet kan spores gennem hele forsyningskæden fra fabrikant til patient. 
In addition, medical devices must have a unique identification number to provide for traceability throughout the supply chain to the patient.
Herudover opstår der ofte myter, fx på sociale medier, om den rette behandling eller behandlingsalternativer uden evidens. 
In addition, myths are often spread on e.g. social media about the right treatment or alternative treatment without evidence.
Dertil kommer, at ny EU-lovgivning står overfor at skulle implementeres i Danmark med deraf følgende nye rammebetingelser for godkendelse af kliniske forsøg, der indføres europæiske procedurer for godkendelse, som minder om procedurerne for godkendelse af lægemidler, og der gennemføres en højere grad af gennemsigtighed på området. 
In addition, new EU legislation will soon be implemented in Denmark, which will provide a new regulatory framework for the authorisation of clinical trials; European procedures for authorisation similar to the procedures for the authorisation of medicinal products will be introduced, and greater transparency will be implemented in this area.
Desuden indstilles et enkelt lægemiddel (nimodipin), der ikke har generelt tilskud i dag, til generelt tilskud. 
In addition, one medicinal product (nimodipine), which is not granted general reimbursement today, is recommended for general reimbursement.
Vi skal også tage det forbehold, at der kan opstå andre omstændigheder, såsom ændret navngivningspraksis eller lignende, der kan bevirke, at navnet ikke kan godkendes. 
In addition, other circumstances may also arise, such as changed naming practice, with the result that the name cannot be approved.
Ligeledes er en bred faglig kompetence afgørende i sager om national videnskabelig rådgivning inden for bl. 
In addition, our professional skills are decisive in cases related to national scientific advice within e.g. clinical trials.
Hertil kommer farmaceutisk-tekniske/fysiske prøver relateret til lægemiddelformen. 
In addition, pharmaceutical-technical tests related to the pharmaceutical form.
Desuden vil recepter udstedt af danske læger eller tandlæger kunne indløses på apoteker i andre EU-/EØS lande. 
In addition, prescriptions issued by Danish doctors or dentists can also be dispensed by pharmacies in other EU/EEA countries.
Endvidere undgås også det problem, at AP og RP indenfor samme version af ASMF ikke godkendes samtidig. 
In addition, situations are avoided in which the AP and RP within the same version of the ASMF are not approved at the same time.
Derudover er der blevet behandlet 130 andre sager om mærkning og emballage på baggrund af rutinemæssig kontrol eller klager fra patienter. 
In addition, some 130 other control cases on labelling and packaging material have been performed based on routine control or in response to complaints from patients.
Derudover skal regnskabet indeholde mængden af høstet cannabis i kilogram. 
In addition, the accounts should state the quantity of harvested cannabis in kilograms.
Lægemiddelstyrelsen kan herudover iværksætte ad hoc revurderinger fx ved nye oplysninger om uhensigtsmæssigt forbrug, nye behandlingsanbefalinger, ændrede priser mm. Lægemiddelstyrelsen følger udviklingen i forbrug og priser for lægemidler omfattet af denne afgørelse.” 
In addition, the Agency can initiate ad hoc reassessments, e.g. when we receive new information about inappropriate consumption, new treatment recommendations, changes in price etc. The Agency monitors the development in the consumption and prices of medicinal products comprised by this decision.”
Derudover viste analyserne, at der er behov for afstemning af flere materialespecifikationer pga. procentvise afvigelser i det deklarerede metalindhold større end grænseværdierne, for både ædelt og uædelt metal, angivet i den harmoniserede standard for dentalmaterialer. 
In addition, the analyses showed that there is a need for reconciliation of several material specifications due to percentage deviations in the declared metallic contents that are greater than the threshold values, for both noble metals and base metals, as specified in the harmonised standard for dental materials.
foruden at nævnet løbende har fulgt blodtrykslægemidlerne, og herunder forbrugsændringerne, før og efter tilskudsændringen den 13. juli 2009. 
In addition, the Committee has kept a close watch on blood pressure medicines, including changes in consumption patterns before and after the reimbursement change of 13 July 2009.
Derudover er Sundhedsstyrelsen i dialog med medicinalfirmaet og de øvrige europæiske lægemiddelmyndigheder om muligheden for flere forebyggende initiativer, der kan forhindre fejldoseringer af krampemedicinen Pro-Epanutin. 
In addition, the Danish Health and Medicines Authority is in dialogue with the pharmaceutical company and other European regulatory authorities about more preventive initiatives to avoid dose errors of the anticonvulsant medicine Pro-Epanutin.
Lægemiddelstyrelsen kan herudover iværksætte ad hoc revurderinger fx ved nye oplysninger om uhensigtsmæssigt forbrug, nye behandlingsanbefalinger, ændrede priser mm. Lægemiddelstyrelsen følger udviklingen i forbrug og priser for lægemidler omfattet af denne afgørelse. 
In addition, the Danish Medicines Agency can initiate ad hoc reassessments, e.g. when receiving new information about inappropriate consumption, new treatment recommendations, changes in price etc. The Danish Medicines Agency monitors the development in consumption and prices comprised by this decision.
Lægemiddelstyrelsen kan herudover iværksætte ad hoc revurderinger fx ved væsentlige nye oplysninger om uhensigtsmæssigt forbrug, nye behandlingsanbefalinger, væsentlige prisændringer mm. Lægemiddelstyrelsen følger udviklingen i forbrug og priser for lægemidler omfattet af denne afgørelse. 
In addition, the Danish Medicines Agency can initiate ad hoc reassessments, e.g. when we receive important new information about inappropriate consumption, new treatment recommendations, significant price changes etc. The Agency monitors the development in the consumption and prices of medicinal products comprised by this decision.
Lægemiddelstyrelsen kan herudover iværksætte ad hoc revurderinger fx ved nye oplysninger om uhensigtsmæssigt forbrug, nye behandlingsanbefalinger, ændrede priser mm. Lægemiddelstyrelsen følger udviklingen i forbrug og priser for lægemidler omfattet af denne afgørelse. 
In addition, the Danish Medicines Agency can initiate ad hoc reassessments, e.g. when we receive new information about inappropriate consumption, new treatment recommendations, changes in price etc. The Danish Medicines Agency monitors the development in consumption and prices comprised by this decision.
Desuden har styrelsen fastsat en øvre grænse for pakningsstørrelsen baseret på mængden af indholdsstof, hvor det er sundhedsfarligt at indtage indholdsstoffet i større mængder. 
In addition, the Danish Medicines Agency has fixed an upper threshold for the package size based on the content of active substance that is dangerous for humans when consumed in large doses.
Derudover har Lægemiddelstyrelsen ikke godkendt produktet Beline Capsules. 
In addition, the Danish Medicines Agency has not authorised the product Beline Capsules.
Derudover deltager Lægemiddelstyrelsen også i EU-Kommissionens Ad Hoc gruppe, som udarbejder vejledninger til fortolkning af forordningen, og Clinical Trials Facilitation Group (CTFG), som fokuserer på de operationelle forandringer i medlemsstaterne. 
In addition, the Danish Medicines Agency participates in the European Commission's Ad Hoc group, which prepares guidelines on the interpretation of the regulation, and in the Clinical Trials Facilitation Group (CTFG), which focuses on operational changes in the member states.
Lægemiddelstyrelsen hjemtager desuden løbende udvalgte lægemidler og kontrollerer pakning og etiket samt analyserer lægemidlerne. 
In addition, the Danish Medicines Agency regularly purchases selected medicinal products to check the packaging information and label and to analyse the medicinal products.
Desuden vil Lægemiddelstyrelsen vurdere mulighederne for at udvide spændet i pakningsstørrelse for at sikre patienternes adgang til de billigste lægemidler. 
In addition, the Danish Medicines Agency will assess the opportunities to widen the span in package size to ensure that patients have access to the least expensive medicinal products.
Herudover vil Lægemiddelstyrelsen og Institut for Rationel Farmakoterapi blive orienteret. 
In addition, the Danish National Board of Health and the Institute for Rational Pharmacotherapy will be notified.
Herudover vil Lægemiddelstyrelsen, Institut for Rationel Farmakoterapi og Medicintilskudsnævnet blive orienteret. 
In addition, the Danish National Board of Health, the Institute for Rational Pharmacotherapy and the Reimbursement Committee have been notified.
Derudover har Fødevarestyrelsen for flere vitaminer udstedt generelle dispensationer til større døgndoser end dem der fremgår af kosttilskudsbekendtgørelsen. 
In addition, the Danish Veterinary and Food Administration has issued general exemptions for larger daily doses for several vitamins than those specified in the Executive Order on food supplements.
Hertil kommer, at efterspørgslen efter en medicin normalt afhænger af behandlingen af en bestemt lidelse, og at de forskellige former for medicin er lidet substituerbare. 
In addition, the demand for a medicinal product usually depends on the treatment of a specific disease, and the different forms of medicine are only generic to a small extent.
Derudover skal forhandleren kontrollere, om tilladelsen er ægte - som udgangspunkt ved at kontrollere, om den er registreret i EudraGMDP-databasen . 
In addition, the distributor should check that the authorisation is authentic - generally, by checking that it is registered in the EudraGMDP database .
Derudover skal forhandleren kontrollere, om tilladelsen er ægte - som udgangspunkt ved at kontrollere, om den er registreret i EudraGMDP-databasen. 
In addition, the distributor should check that the authorisation is authentic - generally, by checking that it is registered in the EudraGMDP database.
Derudover skal dokumentationen omfatte en klinisk evaluering. 
In addition, the documentation must comprise a clinical evaluation.
Herudover skal det pågældende format (eCTD, NeeS eller VNeeS) anføres, og godkendelsesproceduren (CP, DCP, MRP eller NP) skal fremgå af CD'en eller DVD'en, hvis den ikke fremgår implicit af procedurenummeret. 
In addition, the format concerned (eCTD, NeeS or VNeeS) must be specified, and the authorisation procedure applied (CP, DCP, MRP or NP) must appear from the CD or DVD, if this is not implicitly indicated by the procedure number.
Desuden er der tilføjet en oversigt over forskellige krav ved fremstilling, indførsel eller distribution af aktive stoffer. 
In addition, the guidelines present an overview of the requirements as to the manufacture, import or distribution of active substances.
Importen skal desuden forhåndsanmeldes til Landbrugsstyrelsen, som skal lave importkontrol af planterne efter de sædvanlige importprocedurer. 
In addition, the import must in advance be notified to the Danish Agricultural Agency, which will subject the plants to import control according to the usual import procedures.
Desuden skal etiketten, som den unikke identifikator er trykt på, påføres af producenten under GMP-forhold. 
In addition, the label on which the unique identifier is printed should be placed by the manufacturer in compliance with GMP.
Risikovurderingen inddrages endvidere i Lægemiddelstyrelsens laboratoriums risikobaserede udvælgelse af API, hjælpestoffer eller præparater til kontrol. 
In addition, the laboratory of the Danish Medicines Agency will use the risk assessment for its risk-based selection of APIs, excipients and products for control.
Derudover skal de sikre, at der findes en god vejledning i , hvordan testen skal bruges. 
In addition, the manufacturer must provide good guidelines on how to use the test.
Derudover er markedsovervågningsprojektet for 2014 også en opfølgning på inspektionen af dentallaboratorier i 2011, der kan tjene som sammenligningsgrundlag, for at belyse status for området. 
In addition, the market surveillance project 2014 is also a follow-up on the inspection of dental laboratories in 2011, which can serve as a basis for comparison to review the status of the area.
Derudover skal overvågningssystemet sikre at alvorlige hændelser og sikkerhedsrelaterede korrigerende handlinger indberettes til myndighederne. 
In addition, the market surveillance system must ensure that serious incidents and field safety corrective actions are reported to the authorities.
Derudover anvendes lægemidlerne til behandling af migræne, tremor og tyreotoksikose. 
In addition, the medicinal products are used for the treatment of migraine, tremor and thyreotoxicosis.
Derudover har Ministeriet for Sundhed og Forebyggelse udpeget Lægemiddelstyrelsen som tilsynsmyndighed for bemyndigede organer på området medicinsk udstyr og vi varetager den faglige vurdering af grundlaget for bemyndigelsen. 
In addition, the Ministry of Health has appointed the Danish Medicines Agency as regulatory authority for notified bodies within medical devices, and we perform the professional evaluation of the basis for the designation.
Derudover er Sundhedsstyrelsen og Institut for Rationel Farmakoterapi orienteret. 
In addition, the National Board of Health and the Institute for Rational Pharmacotherapy have been briefed.
Udover øget dialog kan netværket også arbejde med konkrete arbejdsopgaver ved nedsættelse af arbejdsgrupper. 
In addition, the network will also work on specific tasks in working groups.
I de nye forordninger stilles der desuden krav om, at medicinsk udstyr skal have et unikt identifikationsnummer (UDI), så produktet kan spores gennem hele forsyningskæden fra fabrikant til patient. 
In addition, the new regulations stipulate that medical devices must have a unique device identification (UDI) to facilitate the traceability throughout the supply chain from manufacturer to patient.
Desuden er antallet af ansøgninger om kliniske forsøg næsten tilbage på samme niveau som i 2006, hvor antallet hidtil var højest. 
In addition, the number of clinical trial applications is almost at the same level as in 2006, which was the peak year.
Desuden er originalmedicin beskyttet mod konkurrence fra kopiprodukterne i en begrænset periode. 
In addition, the original medicine is protected against competition from generic products for a limited period.
Der er også altid information om produktet og bivirkninger i pakningsmaterialet. 
In addition, the packaging material always has information on the product and any side effects.
Herudover har prisen på medicin stor betydning for den enkelte borger og for samfundet. 
In addition, the price of medicines is of great importance to the individual citizen and to society.
Derudover indeholder produktet 12,5 mg koffein per kapsel. 
In addition, the product contains 12.5 mg caffeine per capsule.
Hertil kommer, at formålet med revurdering af lægemidlers tilskudsstatus ikke er besparelser, men at sikre, at lægemidlerne opfylder betingelserne for generelt tilskud. 
In addition, the purpose of reassessing the reimbursement status of medicinal products is not to cut costs, but to ensure that the medicinal products meet the criteria for general reimbursement.
Registreringen bør ligeledes indsendes sammen med et uddybende følgebrev eller følgemail, der beskriver baggrunden for ansøgningen. 
In addition, the registration must be submitted with a detailed cover letter or email, describing the reason for the registration.
Sideløbende revurderes tilskudsstatus for de resterende grupper i hovedgruppe A, som tidligere er meldt ud, foruden at nævnet vil færdiggøre sine indstillinger for grupperne C01 og A01. 
In addition, the Reimbursement Committee will finalise its recommendations for groups C01 and A01.
Hertil kommer, at tilskudsstatus for LevemirogLantus december 2007 blev ændret til generelt tilskud. 
In addition, the reimbursement status for Levemir and Lantus was changed to general reimbursement in 2007.
Desuden skal udskiftningen af anbrudsanordningen udføres i overensstemmelse med GMP (Good Manufacturing Practice) for lægemidler, og parallelimportøren, der lovligt åbner en lægemiddelpakning og påsætter en ny anbrudsanordning, skal forinden have verificeret ægtheden af den unikke identifikator og integriteten af anbrudsanordningen på den originale pakning, i overensstemmelse med artikel 47a, stk. 1, litra a), i direktiv 2001/83 / EF. 
In addition, the replacement of the anti-tampering device must be done in compliance with GMP (Good Manufacturing Practice) for medicinal products, and the parallel importer legally opening a pack of medicinal products and placing a new anti-tampering device on it must verify in advance the authenticity of the unique identifier and the integrity of the anti-tampering device on the original pack in compliance with article 47a(1)(a) of Directive 2001/83/EC.
Derudover sikrer indberetningssystemet, at vi kan sammenholde hyppigheden af en hændelsestype på nationalt og europæisk plan med antallet af produkter på markedet. 
In addition, the reporting system helps us compare the frequency of a type of incident, nationally and in Europe, with the number of products in the market.
Derudover skal sponsor og investigator sikre, at de omfattede dokumenter opbevares på en måde, så de straks kan stilles til rådighed for kontrol. 
In addition, the sponsor and investigator must ensure that the documents are stored in a manner that makes them easily available for control.
Standarden indeholder endvidere krav til farlige stoffer, der står beskrevet, at legeringer ikke må indeholde mere end 0,02 % kadmium og beryllium. 
In addition, the standard contains requirements as to hazardous elements; alloys must not contain more than 0.02% cadmium and beryllium.
Derudover publiceres også tabellen ”Procedurestart Nationale variationer”, der viser status for alle procedurestartede nationale type IB og type II variationer. 
In addition, the table ”Procedure Start Date National variation” showing the status of all initiated national type IB and type II variations is still published.
Derudover opfordres EU 
In addition, the Union institutions
Hertil kommer 78 apoteksfilialer, 124 frivillige oprettet filialer, 48 apoteksudsalg, ca. 500 håndkøbsudsalg og ca. 350 medicinudleveringssteder, der alle er tilknyttet et af apotekerne. 
In addition, there are 78 pharmacy branches, 124 branches set up voluntarily, 48 pharmacy outlets, about 500 over-the-counter outlets and about 350 medicine delivery facilities, all of which are affiliated with one of the pharmacies.
Herudover er der omkring 600 håndkøbsudsalg fra apotekerne. 
In addition, there are around 600 OTC outlets that dispense medicine from pharmacies.
Herudover er der omkring 630 håndkøbsudsalg fra apotekerne. 
In addition, there are around 630 OTC outlets dispatching medicine from pharmacies.
Derudover findes adskillige kombinationsprodukter, hvor man har kombineret et diuretikum med en betablokker, en calciumantagonist, en ACE-hæmmer eller en angiotensin-II antagonist. 
In addition, there are several combination products where a diuretic is combined with a beta blocking agent, a calcium channel blocker, an ACE inhibitor or an angiotensin II antagonist.
Derudover mangler der viden om quetiapins langtidsvirkning på børn og unges vækst og udvikling samt om påvirkningen af den kognitive og adfærdsmæssige udvikling. 
In addition, there is limited evidence of how quetiapine impacts the growth and development of children and adolescents in the long term, including how it impacts cognitive and behavioural development.
Desuden sås en stigning i tilbagekaldelser på baggrund af specifikationsafvigelser. 
In addition, there was an increase in withdrawals effected based on deviations from specifications.
Derudover orienterer de om eventuelle forebyggende tiltag, der er indført med henblik på at forhindre lignende hændelser fx tilbagetrækning eller forbedring af produktet. 
In addition, they inform us of any preventive measures taken to avoid similar incidents, e.g. withdrawal or improvement of a product.
Denne sag har desuden givet anledning til større fokus på dentallaboratoriers kontrol med deres leverandører og øget sporbarhed af materialer. 
In addition, this matter has led to increased focus on dental laboratories' control with their suppliers and increased traceability of materials.