FrancophonIA/ELRC3.0 huggingface dataset:
English: 2.2 Scientific advice and protocol assistance Interest in obtaining scientific advice and protocol assistance remained high
Danish: 2.2 Videnskabelig rådgivning og protokolbistand Stor interesse for videnskabelig rådgivning og protokolbistand
English: All inspections were managed within the legislative deadlines.
Danish: Alle inspektioner blev foretaget inden for den foreskrevne tidsfrist.
English: Review of mifepristone-containing medicines, following safety and efficacy concerns regarding the use of the approved 600mg dose of mifepristone, as compared to the use of a 200mg dose, in the medical termination of developing intra-uterine pregnancy in sequential use with prostaglandin analogue.
Danish: • Gennemgang af lægemidler indeholdende mifepriston som følge af sikkerheds- og effektivitetsbetænkeligheder vedrørende brug af den godkendte dosis på 600 mg mifepriston, sammenholdt med en dosis på 200 mg i forbindelse med medicinsk afbrydelse af intrauterin graviditet med påfølgende anvendelse af prostaglandinanaloger.
English: 2 MEDICINES FOR HUMAN USE
Danish: 2 HUMANMEDICINSKE LÆGEMIDLER
English: Thirteen Community herbal monographs for traditional and well-established herbal medicines were finalised (aniseed, anise oil, bitter-fennel fruit, bitter-fennel-fruit oil, cascara, melissa leaf, passion flower, peppermint oil, primula root, primula flower, rhubarb, sweet-fennel fruit and thyme herb).
Danish: Tretten fællesskabsplantemonografier for traditionelle og veletablerede plantelægemidler blev afsluttet (anisfrø, anisolie, bitter fennikelfrugt, bitter fennikelfrugtolie, vrietorn, melisseblad, passionsblomst, pebermynteolie, primularod, primulablomst, rabarber, sød fennikelfrugt og timian).
English: According to revised EU legislation, Member States can initiate referrals regarding herbal medicines.
Danish: Ifølge den reviderede EU-lovgivning kan medlemsstaterne indlede indbringelsesprocedurer for plantelægemidler, men siden december 2007 er der ikke modtaget henvisninger vedrørende plantelægemidler.
English: The PDCO held its first meeting on 4-5 July 2007.
Danish: Det Pædiatriske Udvalg mødtes den 4.-5. juli 2007 til det første af i alt syv møder.
English: The CHMP concluded that the risks outweigh the benefits and recommended the withdrawal of the marketing authorisation for all veralipride-containing medicines (Article 31 procedure).
Danish: CHMP konkluderede, at risiciene opvejede fordelene, og anbefalede en tilbagetrækning af markedsføringstilladelsen for alle lægemidler indeholdende veraliprid (proceduren i henhold til artikel 31).
English: All variation applications were evaluated within the regulatory time limits.
Danish: Alle ansøgninger om ændringer blev vurderet inden for de foreskrevne sagsbehandlingsfrister.
English: All referrals were processed within the legal timeframe.
Danish: Alle henvisninger blev behandlet inden for den foreskrevne tidsfrist.
English: Medicines for treatment of cancer the most-represented therapeutic area
Danish: Lægemidler til kræftbehandling var det mest repræsenterede behandlingsområde
English: The Agency's Committee on Herbal Medicinal Products (HMPC) released for consultation 16 draft Community herbal monographs for traditional and well-established herbal medicines (birch leaf, butcher's broom, calendula flower, elder flower, eleutherococcus root, European goldenrod, hop strobiles, horsetail herb, melilot, mullein flower, nettle herb, oat fruit, oat herb, peppermint leaf, purple coneflower herb and willow bark).
Danish: Agenturets Udvalg for Plantelægemidler (HMPC) fremlagde 16 udkast til fællesskabsplantemonografier for traditionelle og veletablerede plantelægemidler til høring (birkeblade, musetorn, morgenfrue, hyldeblomst, tornaralierod, europæisk gyldenris, humle, padderokke, stenkløver, kongelysblomst, nælde, havreblomst, pebermynteblad, purpur solhat og pilebark).
English: The CHMP recommended new contra-indications for 20 centrally authorised medicines, and in some instances for the entire classes of centrally authorised medicines (class labelling), including: Viracept (nelfinavir mesilate): co-administration with omeprazole;
Danish: CHMP anbefalede, at der fastsættes nye kontraindikationer for 20 centralt godkendte lægemidler og i visse tilfælde for hele klasser af centralt godkendte lægemidler (klassificering), herunder:
English: No such restrictions were recommended for the remaining indication, the treatment of community-acquired pneumonia;
Danish: Sådanne begrænsninger blev ikke anbefalet for den sidste indikation, nemlig behandling af lungebetændelse opstået efter kontakt med pleje- eller hospitalssektoren (samfundserhvervet pneumoni).
English: Action plan for European Surveillance Strategy
Danish: Handlingsplan for den europæiske overvågningsstrategi (ESS) for veterinærlægemidler
English: The EMEA experienced yet another year of increases in all of its areas of activity.
Danish: Også i 2007 var der stigende aktivitet inden for alle EMEA's arbejdsområder.
English: Four entries to the list were released for public consultation (aniseed, calendula flower, eleutherococcus root and purple coneflower herb).
Danish: Fire forslag til fortegnelsen blev fremlagt til offentlig høring (anisfrø, morgenfrueblomst, tornaralierod og purpur solhat).
English: Forty-four orphan-designated medicines authorised for use in the EU
Danish: Godkendelse af 44 lægemidler til sjældne sygdomme til brug i EU
English: Marked increase in expedited reporting of suspected adverse reactions observed
Danish: Markant stigning i den fremskyndede indberetning af formodede bivirkninger
English: Medicines to treat cancer still dominate
Danish: Lægemidler til kræft stadig det vigtigste behandlingsområde
English: Definition and implementation of EU Telematics controlled terms continued.
Danish: EU Telematics Controlled Arbejdet med at definere og implementere EU Telematics
English: Activities relating to orphan designation and scientific advice on the rise
Danish: Stigning i aktiviteter relateret til udpegelse af lægemidler til sjældne sygdomme og videnskabelig rådgivning
English: Acomplia (rimonabant): ongoing major depressive illness and/or ongoing antidepressive treatment; Agenerase, Aptivus, Crixivan, Invirase, Kaletra, Norvir, Prezista, Reyataz, Telzir, Viracept (protease inhibitors): concomitant use with oral midazolam (while further directions concerning co administration with parenteral midazolam are provided in the SPC) (class labelling); Pegintron (peginterferon alpha 2b), Viraferonpeg (peginterferon alpha 2b) and Rebetol (ribavirin):
Danish: • Agenerase, Aptivus, Crixivan, Invirase, Kaletra, Norvir, Prezista, Reyataz, Telzir og Viracept (proteaseinhibitorer): Indgives sammen med oral midazolam (yderligere retningslinjer vedrørende samtidig indgivelse med paranteral midazolam findes i produktresuméet) (klassificering).
English: The EMEA participated in the planning process at the level of the Heads of Medicines Agencies.
Danish: EMEA og cheferne for de nationale lægemiddelmyndigheder deltog i denne proces.
English: The CHMP concluded that the benefits of these medicines do not outweigh their risks and therefore recommended that the marketing authorisations for clobutinol-containing medicines be withdrawn throughout the EU (Article 107(2) procedure).
Danish: CHMP konkluderede, at fordelene ikke opvejede risiciene ved disse lægemidler, og anbefalede derfor en tilbagetrækning af markedsføringstilladelserne for lægemidler indeholdende clobutinol i hele EU (proceduren i henhold til artikel 107, stk. 2).
English: The CHMP concluded the risks of these medicines outweigh their benefits and recommended the suspension of the marketing authorisations (Article 107(2) procedure).
Danish: CHMP konkluderede, at risiciene opvejede fordelene ved disse lægemidler, og anbefalede at suspendere markedsføringstilladelsen (proceduren i henhold til artikel 107, stk. 2).
English: EudraVigilance (In production)
Danish: EudraVigilance (i produktion)
English: Type-II (clinical) variations
Danish: Type-II (clinical) variatio ns
English: Opinions on maximum residue limits
Danish: Udtalelser om maksimalgrænseværdier for restkoncentrationer
English: A total of 6 referral procedures relating to veterinary medicines were initiated, of which 1 related to safety concerns for existing medicines.
Danish: Der blev indledt i alt 6 sager vedrørende veterinærlægemidler.
English: Review of lumiracoxib-containing medicines, intended for the treatment of osteoarthritis, further to notification by the UK, which was considering the suspension of the marketing authorisation due to possible increased risk of hepatotoxic adverse events at the 100mg dose.
Danish: • Gennemgang af lægemidler indeholdende lumiracoxib til behandling af osteoarthritis efter anmeldelse fra Det Forenede Kongerige, som overvejede at suspendere markedsføringstilladelsen på grund af mulig øget risiko for hepatotoksiske bivirkninger ved dosis på 100 mg. CHMP anbefalede en tilbagetrækning af markedsføringstilladelserne for alle lægemidler indeholdende lumiracoxib på grund af risikoen for alvorlige bivirkninger, der berører leveren (proceduren i henhold til artikel 107, stk. 2).
English: A total of 125 applications were received for the designation of orphan medicines - the fourth consecutive year in which more than one hundred such applications have been submitted.
Danish: For fjerde år i træk modtog EMEA over hundrede ansøgninger om udpegelse af lægemidler til sjældne sygdomme, og der blev i 2007 i alt indgivet 125 ansøgninger.
English: New guidance available
Danish: Nye retningslinjer
English: Alimentary tract
Danish: A limentary tract
English: Cancer again the main therapeutic area represented
Danish: Kræft er stadig det vigtigste behandlingsområde
English: EudraGMP (In production)
Danish: EudraGMP (i produktion)
English: EU Telematics Controlled Terms (In pilot production)
Danish: Terms (i pilotproduktion)
English: EudraPharm (In production)
Danish: EudraPharm (i produktion)
English: However, in pregnancies up to 49 days, comparative studies between 200mg and 600mg mifepristone in combination with 400μg misoprostol delivered orally cannot exclude a slightly higher risk of continuing pregnancies with the 200mg dose.
Danish: 400 µg misoprostol indgivet vaginalt dog ikke udelukke en let forhøjet risiko for fortsat graviditet ved en dosis på 200mg.
English: initiation of treatment of hepatitis C in patients with hepatitis C and HIV co-infection who have cirrhosis and a Child-Pugh score of 6 or higher.
Danish: • Pegintron (peginterferon alpha 2b), Viraferonpeg (peginterferon alpha 2b) og Rebetol (ribavirin): Påbegyndelse af behandling af hepatitis C hos patienter, der er co-inficeret med hepatitis C og hiv, som har cirrose og en Child-Pugh-score på 6 eller derover.
English: EudraCT (In production)
Danish: EudraCT (i produktion)
English: General contribution
Danish: Hovedaktiviteter
English: Immunotherapy and oncology
Danish: Immuno therapy and o nco lo gy
English: EudraNet (In production)
Danish: EudraNet (i produktion)
English: The CHMP recommended the deletion of contra-indications for 12 centrally authorised medicines, and in some instances for the entire class of centrally authorised medicines (class labelling), including: pioglitazone- (Actos, Glustin, Competact, Tandemact) and rosiglitazone- (Avandia, Avandamet,
Danish: CHMP anbefalede at slette kontraindikationerne for 12 centralt godkendte lægemidler og i visse tilfælde for hele klasser af centralt godkendte lægemidler (klassificering), herunder følgende:
English: Avaglim) containing medicines: deletion of the contra-indication for their combined use with insulins (class labelling);
Danish: • Lægemidler, der indeholder pioglitazon (Actos, Glustin, Competact og Tandemact) og rosiglitazon (Avandia, Avandamet og Avaglim): Ophævelse af kontraindikation for brug heraf i kombination med insulin (klassificering).
English: However, the CHMP considered that few points merit further clarification.
Danish: CHMP fandt dog, at nogle få punkter krævede nærmere afklaring.
English: The conditions affecting the marketing authorisations are set out in Annex IV.
Danish: Betingelserne for markedsføringstilladelserne fremgår af bilag IV.
English: Auto-injectors were invented in the 1960s following military research in the United States of America (USA).
Danish: Autoinjektorer blev opfundet i 1960'erne efter militær forskning i USA.
English: The first adrenaline auto-injectors (AAI) were developed and introduced into the medical market approximately 25 years ago in the USA.
Danish: De første adrenalinautoinjektorer (AAI) blev udviklet og bragt på lægemiddelmarkedet for ca. 25 år siden i USA.
English: The matter was then referred to the Committee for Medicinal Products for Human Use (CHMP) for a review under Article 31 of Directive 2001/83/EC.
Danish: Sagen blev derefter henvist til Udvalget for Lægemidler til Mennesker (CHMP) med henblik på gennemgang i henhold til artikel 31 i direktiv 2001/83 /EF.
English: Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Danish: Bilag II Videnskabelige konklusioner og begrundelse for ændring af betingelserne for markedsføringstilladelserne
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for adrenaline auto-injectors.
Danish: • CHMP fulgte proceduren i overensstemmelse med artikel 31 i direktiv 2001/83/EF for adrenalin-autoinjektorer,
English: The fact that 15% of mothers were unable to ‘fire' the auto-injector successfully supports that patients' training tools need to be improved and that training needs to be repeated at regular intervals.
Danish: Det forhold, at 15 % af mødrene var ude af stand til at "affyre" autoinjektoren, taler for, at der behøves bedre værktøjer til oplæring af patienter, og at oplæringen bør gentages regelmæssigt.
English: The CHMP acknowledged that patient/carer compliance with the use of the auto-injectors is also very important as evidenced by the study by Brown J et al (2015)7.
Danish: CHMP vedgik, at compliance hos patienten/omsorgsgiveren ved anvendelse af autoinjektorer også er meget vigtig, som det fremgår af undersøgelsen ved Brown J et al (2015)7.
English: The barrier of the fascia lata - the fibrous tissue surrounding the muscle - also needs to be considered.
Danish: Også barrieren bestående i fascia lata - bindevævshinden omkring lårmusklen - må tages i betragtning.
English: Grounds for the CHMP opinion Whereas
Danish: Begrundelse for CHMP's udtalelse Ud fra følgende betragtninger:
English: The main clinical data available focus on demonstrating the skin-to-muscle depth (STMD) in adults and children and the CHMP noted that there is inconsistency across the studies with some finding no correlation between STMD and Body Mass Index (BMI) or weight (Song (2005)3, Stecher (2009)4) and others finding a correlation (Bhalla (2013)5, Bewick (2013)6).
Danish: De vigtigste foreliggende kliniske data tager sigte mod at påvise afstand fra hud til muskel (STMD) hos voksne og børn, men CHMP konstaterede uoverensstemmelse mellem undersøgelserne, hvoraf nogle ikke finder korrelation mellem STMD og legemsmasseindeks (BMI) eller vægt (Song (2005)3, Stecher (2009)4), mens andre finder en sådan korrelation (Bhalla (2013)5, Bewick (2013)6).
English: The CHMP noted the lack of clinical evidence from randomised, controlled trials, due to the logistical and ethical problems involved with conducting such trials in emergency situations, particularly with a placebo control.
Danish: CHMP bemærkede, at der savnedes klinisk evidens fra randomiserede, kontrollerede undersøgelser på grund af logistiske og etiske problemer ved at gennemføre sådanne undersøgelser i akutsituationer, navnlig med placebokontrol.
English: They were originally used for the administration in the field of atropine, the antidote to nerve agents in biological weapons.
Danish: Oprindelig blev de anvendt i felten til at administrere atropin som antidot til nervegifte i biologiske våben.
English: Therefore, in accordance with Articles 31 and 32 of Directive 2001/83/EC, the CHMP recommends the variation to the terms of the marketing authorisation for all medicinal products referred to in Annex I and for which the amendments of the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III.
Danish: anbefalede CHMP i overensstemmelse med artikel 31 og 32 i direktiv 2000/83/EF ændring af markedsføringstilladelsen for alle lægemidler omhandlet i bilag I, for hvilke ændringerne af de relevante afsnit af produktresuméet, og indlægssedlen fremgår af bilag III.
English: Results from PK studies (Simons, 19981, 20012) support the guidelines recommendation (e.g. UK Resuscitation Guideline) that an intramuscular injection is the preferred route of administration in the treatment of anaphylaxis as a rapid response is important in ensuring a non-fatal outcome.
Danish: Farmakokinetiske undersøgelser (Simons, 19981, 20012) støtter anbefalingerne i retningslinjer som f.eks. UK Resuscitation Guideline om, at intramuskulær injektion er den foretrukne administrationsvej ved behandling af anafylaksi, da hurtig respons er vigtig for at sikre ikke-fatalt udfald.
English: The CHMP considered also the results of consultations with healthcare professionals, experts and the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: CHMP henholdt sig desuden til resultaterne af drøftelserne med sundhedspersoner, eksperter og Udvalget For Risikovurdering inden for Lægemiddelvurdering (PRAC).
English: If IM delivery is insufficient with one injection, administration of a second injection is recommended.
Danish: Hvis der er utilstrækkelig intramuskulær afgivelse med en enkelt injektion, anbefales det at give endnu en injektion.
English: The PRAC considered that there were no identified data sources that would permit a formal epidemiological approach for assessing actual usage or device failure of adrenaline auto-injectors in the EU.
Danish: PRAC tog i betragtning, at der ikke var udpeget datakilder, der muliggør en formel epidemiologisk vurdering af den faktiske anvendelse eller svigt af adrenalin-autoinjektorer i EU.
English: Until these uncertainties can be resolved, there is a need for more definitive evidence in humans of the speed and extent of delivery of adrenaline into the circulation following use of different adrenaline auto-injectors, from which it may be possible to infer site of delivery.
Danish: Indtil disse punkter kan afklares, behøves der mere definitiv evidens hos mennesker vedrørende hastigheden og omfanget af adrenalinafgivelsen til blodbanen efter anvendelse af forskellige adrenalin-autoinjektorer, hvorved man ville kunne udlede afgivelsesstedet.
English: The experts consulted unanimously agreed that a PK study in humans would be useful in order to gain information on the optimum parameters of administration; the group also noted the possibility to collect PD data in this same study.
Danish: De rådspurgte eksperter var samstemmende af den opfattelse, at en farmakokinetisk undersøgelse hos mennesker ville være nyttig til at skaffe oplysninger om de optimale administrationsparametre; gruppen nævnte desuden muligheden for at indsamle farmakodynamiske data i samme undersøgelse.
English: The safety of adrenaline is also well-established, and it has demonstrated a particularly strong safety profile with intramuscular (IM) administration.
Danish: Sikkerheden af adrenalin er også veletableret, og sikkerhedsprofilen har vist sig særlig stærk ved intramuskulær administration.
English: Adrenaline auto-injectors are indicated in the emergency treatment of severe allergic reactions (anaphylaxis) to e.g. insect stings or bites, foods, drugs and other allergens as well as idiopathic or exercise-induced anaphylaxis.
Danish: Adrenalin-autoinjektorer er indiceret til akut behandling af svære allergiske reaktioner (anafylaksi) over for f.eks. insektstik eller -bid, fødevarer, lægemidler og andre allergener samt ved idiopatisk eller motionsfremkaldt anafylaksi.
English: However, there is insufficient evidence to ensure, even under optimal circumstances, IM delivery of adrenaline to all patients with the currently available auto-injectors authorised in the EU and, even if the medicine is delivered IM, that exposure from a single injection will be sufficient.
Danish: Der er imidlertid ikke tilstrækkelig evidens for, at der selv under optimale omstændigheder sikres intramuskulær afgivelse af adrenalin til alle patienter med de aktuelt tilgængelige i EU godkendte autoinjektorer, heller ikke, at en enkelt injektion medfører tilstrækkelig eksponering, selv hvis lægemidlet afgives intramuskulært.
English: The educational materials include but are not limited to a training device, instructional audio-visual material and a checklist for prescribers aiming to facilitate the discussion between the prescriber and the patient and to provide sufficient information on the optimal way of use, administration and storage of the product.
Danish: Informationsmaterialet omfatter bl.a. en øvelsesanordning, audiovisuelt instruktionsmateriale og en tjekliste for ordinerende læger for at fremme drøftelsen mellem den ordinerende læge og patienten og give den fornødne information om produktets optimale anvendelse, administration og opbevaring.
English: The CHMP agreed that proper training of both patients/carers and healthcare professionals and comprehensive educational materials are of paramount importance.
Danish: CHMP fandt det altafgørende med tilstrækkelig oplæring af både patienter/omsorgsgivere og sundhedspersoner samt fyldestgørende oplysningsmateriale.
English: The use of adrenaline to treat anaphylaxis is established as the recommended first-line treatment.
Danish: Anvendelsen af adrenalin til behandling af anafylaksi er anerkendt som den anbefalede førstevalgsbehandling.
English: The needle length is another factor and the UK Resuscitation Council Guidelines do suggest a 25mm needle is optimal for intramuscular injection; however the CHMP noted that these guidelines are written for use in the hospital setting where healthcare professionals will generally inject the adrenaline using a manual needle and syringe, not an auto-injector.
Danish: Nålens længde er en af disse faktorer, og UK Resuscitation Council Guidelines angiver da også, at en 25 mm nål er optimal til intramuskulær injektion; CHMP bemærkede imidlertid, at disse retningslinjer tager sigte på hospitalsomgivelser, hvor adrenalinet sædvanligvis injiceres af personalet med en manuel nål og sprøjte, ikke en autoinjektor.
English: • The CHMP concluded that there was a need for further risk minimisation measures such as educational materials to be submitted and agreed via risk management plans.
Danish: • CHMP konkluderede, der var behov for yderligere risikominimeringsforanstaltninger såsom oplysningsmateriale, som forelægges og godkendes gennem risikohåndteringsplaner.
English: The CHMP noted that generally there is a large degree of consistency between the product information for the different auto-injectors in particular as regards main messages such as to seek emergency medical assistance immediately after a single administration, the use with caution in certain patient populations and that adrenaline should be administered intramuscularly in order to maximise the possibility of a positive outcome in the treatment of anaphylaxis.
Danish: CHMP bemærkede, at der generelt er høj grad af overensstemmelse mellem produktinformationerne for de forskellige autoinjektorer, navnlig i hovedbudskaberne såsom om at søge akut lægehjælp straks efter en enkelt administration, forsigtighed ved anvendelse hos visse patientgrupper, og at adrenalin bør administreres intramuskulært for at maksimere muligheden for positivt udfald ved behandling af anafylaksi.
English: The preferred route of administration in an emergency situation has been established as IM, although intravenous administration may be indicated in severe cases.
Danish: Den foretrukne administrationsvej ved akuttilstande er fastslået at være intramuskulær, dog kan intravenøs administration være indiceret i svære tilfælde.