FrancophonIA/ELRC3.0 huggingface dataset:
English: In conclusion, the CHMP agreed that whilst the use of a Cu-IUD may be the preferred option for emergency contraception for use with all enzyme inducers, recommending a double dose of LNG EHC represents a pragmatic management option, with no significant known safety issues, to reduce the risk of contraceptive failure for women unable or unwilling to use a Cu-IUD.
Danish: CHMP anerkender, at selv om brugen af kobberindlæg måske er det foretrukne valg for nødprævention, der kan bruges sammen med alle enzym-inducere, er anbefaling af en dobbeltdosis levonorgestrel som hormonel nødprævention en pragmatisk behandlingsmulighed uden væsentlige kendte sikkerhedsproblemer til reduktion af risikoen for præventionssvigt for kvinder, der ikke kan eller ikke vil bruge et kobberindlæg.
English: In view of the above, the Committee considers that the benefit-risk balance of Levonelle 1500mcg and associated names remains favourable subject to the agreed amendments to the product information.
Danish: I lyset af ovenstående mener udvalget, at benefit/risk-forholdet for Levonelle 1500 µg er positivt under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: On this basis a double dose of LNG EHC for EFV users and all other enzyme inducers is recommended.
Danish: På grundlag af dette anbefales en dobbeltdosis levonorgestrel som hormonel nødprævention for brugere af efavirenz og alle andre enzym-inducere.
English: Interestingly, a recent publication of a small PK study4 in obese women vs normal BMI women found that Cmax and AUC(0-2.5h) of total LNG was doubled when a double dose of LNG EHC (3000mcg LNG) was used.
Danish: En nylig publikation4 vedrørende en lille farmakokinetisk undersøgelse af overvægtige kvinder versus normalvægtige kvinder viste interessant nok, at Cmax og AUC(0-2,5t) for total levonorgestrel blev fordoblet, når der blev anvendt en dobbeltdosis levonorgestrel som hormonel nødprævention (3 000 µg levonorgestrel).
English: Although there are few adverse drug reaction (ADR) reports of contraceptive failure during concomitant use of enzyme inducers with LNG EHC, and none with efavirenz specifically, this is likely linked to significant under-reporting for loss of efficacy in general when expected contraceptive failure rates and widespread use of LNG EHC are considered.
Danish: Selv om der kun er få indberetninger om præventionssvigt i bivirkningsrapporterne ved samtidig brug af enzym-inducere og levonorgestrel som hormonel nødprævention, og ingen specifikke indberetninger vedrørende efavirenz, skyldes dette sandsynligvis betydelig underrapportering af tab af effekt generelt, når man tager den forventede forekomst af præventionssvigt og den udbredte brug af levonorgestrel som hormonel nødprævention i betragtning.
English: The SmPCs for regular contraception products containing LNG advise using additional or alternative methods of contraception, depending on the duration of use of the enzyme inducer.
Danish: Produktresuméerne for almindelige levonorgestrel-holdige præventionsmidler anbefaler brug af supplerende eller anden prævention, alt efter hvor lang tid enzym-induceren skal tages.
English: The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for Levonelle 1500mcg and associated names.
Danish: CHMP anbefaler derfor, at betingelserne for markedsføringstilladelserne for Levonelle 1500 µg ændres.
English: Notably both contraceptive efficacy studies mentioned here required or allowed repeat use of LNG during the cycle and these studies examined contraceptive efficacy when LNG was used within 3 or 8 hours after UPSI and not when it used according to the current regimen, that is, within 72 hours of UPSI.
Danish: påkrævet eller tilladt, og de så nærmere på præventionseffekten, når levonorgestrel blev taget inden for 3 eller 8 timer efter ubeskyttet samleje og ikke, når levonorgestrel blev brugt i henhold til det aktuelle regimen, dvs. inden for 72 timer efter ubeskyttet samleje.
English: The study of Carten et al. (2012)1, used a cross-over design, a clinically relevant dose of efavirenz and the size was reasonable for a drug-drug interaction (DDI) study.
Danish: (i) Reduktion i plasmaniveauet ved brug af efavirenz og andre enzym-inducere Carten et al.-undersøgelsen (2012)1 anvendte et overkrydsningsdesign og en klinisk relevant dosis efavirenz, og størrelsen var rimelig for en lægemiddelinteraktionsundersøgelse.
English: The CHMP acknowledged the limited clinical data regarding lack of efficacy of LNG-containing contraceptives with concomitant use of CYP 3A4 enzyme inducers by which to judge the clinical significance of reduced plasma LNG levels during EHC.
Danish: CHMP anerkender, at de kliniske data til påvisning af manglende effekt af levonorgestrel-holdige præventionsmidler ved samtidig brug af CYP3A4-enzym-inducere er begrænsede, når man skal vurdere den kliniske betydning af reduceret levonorgestrel-koncentration i plasma ved brug af levonorgestrel som hormonel nødprævention.
English: In addition as the scientific conclusions of this assessment apply as well to the 750mcg LNG-containing medicinal products indicated in emergency contraception, the MAHs should take note of this recommendation and apply the scientific conclusions to those products accordingly.
Danish: Desuden bør indehaverne af markedsføringstilladelser tage højde for denne anbefaling og anvende de videnskabelige konklusioner vedrørende disse produkter i overensstemmelse hermed, da konklusionerne også finder anvendelse på lægemidler med 750 µg levonorgestrel, der er indiceret til nødprævention.
English: Specific data for interactions of other enzyme-inducers with EHC doses of LNG are not currently available.
Danish: Aktuelt foreligger der ingen specifikke data vedrørende interaktioner mellem andre enzym-inducere og levonorgestrel som hormonel nødprævention.
English: Therefore the CHMP recommended that clear SmPC advice on managing these interactions is needed for all potential EHC providers.
Danish: Derfor anbefaler CHMP, at produktresuméet skal indeholde klar vejledning om håndteringen af disse interaktioner til alle læger, der kan ordinere hormonel nødprævention.
English: Currently the minimally effective dose for LNG EHC is not known.
Danish: Den laveste effektive dosis af levonorgestrel som hormonel nødprævention kendes ikke på nuværende tidspunkt.
English: Specialist clinics are not necessarily aware of the importance of the interactions and women rely on specialist clinical advice.
Danish: Kvinderne er henvist til rådgivning fra speciallægen, der ikke nødvendigvis er klar over betydningen af interaktionerne.
English: Limited data with a 6mg dose of LNG shows higher Cmax than seen with 1.5mg, suggesting that saturation of LNG uptake does not occur at the standard EHC dose.
Danish: Cmax end ved 1,5 mg, hvilket tyder på, at der ikke sker mætning af levonorgestrel-optagelsen ved standarddosen for hormonel nødprævention.
English: There are also limited data on whether lower levels of LNG may be effective for EHC.
Danish: De foreliggende data om, hvorvidt et lavere plasmaniveau af levonorgestrel er effektivt som hormonel nødprævention, er også begrænsede.
English: In this case, additional studies may be needed.
Danish: I dette tilfælde kan der være behov for yderligere studier.
English: It can also be due to increased market competition.
Danish: Det kan også skyldes øget konkurrence på markedet.
English: These fall within the remit of EU Member States.
Danish: Det hører ind under EU-medlemsstaternes beføjelser.
English: * The definitions included in this document and in the glossary are descriptions, not regulatory definitions.
Danish: * Definitionerne i dette dokument og i ordlisten er beskrivelser, ikke lovgivningsmæssige definitioner.
English: Replacement can be done by:
Danish: Udskiftningen kan ske ved:
English: (‘microheterogeneity').
Danish: (“mikroheterogenitet”).
English: In this case, they are monitored particularly closely during the first years after approval.
Danish: I så fald overvåges de særligt nøje i løbet af det første år efter godkendelsen.
English: This has helped to shape current requirements for approval.
Danish: Det har bidraget til de nuværende godkendelseskrav.
English: Generally possible to obtain exactly the same molecule
Danish: Almindeligvis muligt at opnå nøjagtigt samme molekyle
English: EMA and Member States' responsibilities
Danish: EMA og medlemsstaternes ansvar
English: European Commission: What I need to know about biosimilar medicines.
Danish: Europa-Kommissionen: What I need to know about biosimilar medicines.
English: A change to the manufacturing process must always be approved by regulators.
Danish: En ændring af fremstillingsprocessen skal altid godkendes af de regulerende myndigheder.
English: Thus, they are expected to be less costly for healthcare systems in the EU.
Danish: De kan derfor forventes at medføre lavere omkostninger for sundhedssystemerne i EU.
English: Usually produced by chemical synthesis
Danish: Normalt fremstillet ved kemisk syntese
English: Interchangeability, switching and substitution: EMA and Member States' responsibilities
Danish: Indbyrdes udskiftelighed, skift og substitution: EMA og medlemsstaternes ansvar
English: The EU legislation imposes strict requirements for the manufacture of all medicines:
Danish: EUlovgivningen fastsætter strenge krav til fremstilling af alle lægemidler:
English: Efficacy and safety have to be justified in each indication.
Danish: Virkning og sikkerhed skal begrundes i hver indikation.
English: Expected impact
Danish: Forventet påvirkning
English: These include:
Danish: De omfatter:
English: “This medicinal product is subject to additional monitoring”
Danish: “Dette lægemiddel er underlagt supplerende overvågning”
English: Additional monitoring and black triangle
Danish: Supplerende overvågning og sort trekant
English: The nature of immune reactions depends on many factors
Danish: Immunreaktionens karakter afhænger af mange faktorer
English: In general, the amount and type of data will depend on several factors, including:
Danish: Generelt vil mængden og typen af data afhænge af en række faktorer, herunder:
English: Foreword by Prof. Guido Rasi EMA Executive Director
Danish: Forord af professor Guido Rasi, EMA's administrerende direktør
English: European public assessment report
Danish: Europæisk offentlig vurderingsrapport
English: Reason for varying amount/type of data
Danish: Årsag til varierende mængde/type data
English: Does not affect the pharmaceutical quality of the medicine (no impact on product specifications)
Danish: Påvirker ikke lægemidlets farmaceutiske kvalitet (ingen indvirkning på produktspecifikationer)
English: Insulin 5,808 daltons
Danish: Insulin 5 808 dalton
English: The studies to prove pharmaceutical quality should provide detailed data on:
Danish: Studier til at demonstrerer den farmaceutiske kvalitet skal give detaljerede oplysninger om:
English: The immune system has the ability to recognise foreign proteins and react against them.
Danish: Immunsystemet kan genkende fremmede proteiner og reagere imod dem.
English: Same strict standards of quality, safety and efficacy
Danish: Samme strenge standarder for kvalitet, sikkerhed og virkning
English: Determining factor
Danish: Bestemmende faktor
English: This covers the time from release by the manufacturer and progress through the entire distribution chain until the medicine is administered to the patient.
Danish: Det dækker tiden fra frigivelse fra fabrikanten og forløbet gennem hele distributionskæden, indtil lægemidlet administreres til patienten.
English: This means that patients and healthy volunteers will not be subjected to unnecessary clinical trials.
Danish: Det betyder, at patienter og raske frivillige ikke udsættes for unødvendige kliniske forsøg.
English: Periodic safety update report
Danish: Periodisk, opdateret sikkerhedsindberetning
English: Data on biosimilarity: published in the assessment report
Danish: Data om biosimilaritet: Offentliggjort i vurderingsrapporten
English: Growth hormone 22,000 daltons
Danish: Væksthormon 22 000 dalton
English: International nonproprietary name, a unique name that identifies active substances.
Danish: Internationalt fællesnavn, som er et unikt navn, der identificerer virksomme stoffer.
English: May possibly affect safety or efficacy
Danish: Kan muligvis påvirke sikkerhed eller virkning
English: The extent of clinical studies needed for approval depends on several factors, including those outlined in table 6.
Danish: Omfanget af kliniske studier, der er nødvendige til godkendelse, afhænger af adskillige faktorer, herunder dem, der er anført i tabel 6.
English: Analytical studies are the first step in assessing potential for immunogenicity.
Danish: Analytiske studier er det første trin i vurderingen af potentialet for immunogenicitet.
English: PD endpoints are usually based on laboratory tests.
Danish: PD-endepunkter er normalt baseret på laboratorieforsøg.
English: Examples include:
Danish: Som eksempler kan nævnes:
English: Over 50 biosimilars have been approved through EMA for use in the EU as at April 2017.
Danish: Over 50 biosimilære lægemidler var godkendt via EMA til anvendelse i EU pr. april 2017.
English: Several national regulatory authorities also provide information on biosimilars in their local language.
Danish: Flere nationale regulerende myndigheder giver også oplysninger om biosimilære lægemidler på deres eget sprog.
English: If some manufacturing steps take place outside the EU, then non-EU manufacturers, importers and wholesale distributors are obliged to follow the same strict requirements and are also regularly inspected.
Danish: Hvis der er trin i fremstillingen, som foregår uden for EU, er producenter, importører og grossister uden for EU forpligtet til at overholde de samme strenge krav og inspiceres også regelmæssigt.
English: Relevant study population
Danish: Relevant studiepopulation
English: Suspected ADRs are those that have been reported to authorities but which are not necessarily caused by the medicine.
Danish: Formodede bivirkninger er dem, der er indberettet til myndighederne, men som ikke nødvendigvis er forårsaget af lægemidlet.
English: All new medicines are closely monitored after being introduced to the market.
Danish: Alle nye lægemidler overvåges nøje, efter at de er blevet markedsført.
English: Immunogenicity is not a safety concern in itself
Danish: Immunogenicitet afføder ikke i sig selv sikkerhedsmæssige betænkeligheder
English: This is why at the time of approval regulators may impose on the company an obligation to carry out a postauthorisation safety study (PASS).
Danish: Derfor kan de regulerende myndigheder på godkendelsestidspunktet pålægge virksomheden at udføre en sikkerhedsundersøgelse efter tilladelse til markedsføring (PASS).
English: Biological medicines approved after 1 January 2011 are subject to socalled ‘additional monitoring' and are included in a list of medicines under ‘additional monitoring'.
Danish: Biologiske lægemidler, der er godkendt efter den 1. januar 2011, er underlagt “supplerende overvågning” og står på en liste over lægemidler underlagt supplerende overvågning.
English: Large molecular structure
Danish: Stor molekylestruktur
English: Extrapolation of immunogenicity data is not automatic, as it always requires justification.
Danish: Ekstrapolering af data om immunogenicitet sker ikke automatisk, da den altid skal være begrundet.
English: Proteins Growth factors
Danish: Proteiner Vækstfaktorer
English: This guide has been prepared by the European Medicines Agency in collaboration with the European Commission and scientific experts from EU Member States.
Danish: Denne håndbog er udarbejdet af Det Europæiske Lægemiddelagentur i samarbejde med EuropaKommissionen og videnskabelige eksperter fra EU's medlemsstater.
English: If a biological medicine (or biosimilar) is labelled with a black triangle, it does not necessarily mean that there are additional safety concerns with it.
Danish: Hvis et biologisk (eller biosimilært) lægemiddel er mærket med en sort trekant, betyder det ikke nødvendigvis, at der er yderligere sikkerhedsproblemer med det.
English: Acceptance limits for important quality standards which an active substance or a finished medicine must meet.
Danish: Grænseværdier for vigtige kvalitetsstandarder, som et virksomt stof eller et færdigt lægemiddel skal opfylde.
English: National regulatory authorities in the EU regularly inspect manufacturing sites for compliance with GMP requirements.
Danish: De nationale reguleringsmyndigheder i EU inspicerer regelmæssigt produktionsstederne for at kontrollere overholdelsen af GMP-kravene.
English: Healthy volunteers can be selected if they represent the most appropriate population to detect such differences and if the medicines' toxicity is not a cause of concern.
Danish: Raske frivillige kan vælges, hvis de udgør den mest hensigtsmæssige population til at afdække sådanne forskelle, og hvis lægemidlernes toksicitet ikke giver anledning til bekymring.
English: Limited physicochemical studies comparing batches before and after the change
Danish: Begrænsede fysisk-kemiske studier, som sammenligner batches før og efter ændringen
English: Adequate equivalence margins should be chosen for the primary efficacy endpoint.
Danish: Der bør vælges tilstrækkelige ækvivalensmarginer for det primære effektendepunkt.
English: May affect product characteristics or specifications but not expected to affect safety or efficacy
Danish: Kan påvirke produktets karakteristika eller specifikationer, men forventes ikke at påvirke sikkerhed eller virkning
English: This is achieved with a robust manufacturing process to ensure that all batches of the medicine are of proven quality.
Danish: Det opnås med en robust fremstillingsproces for at sikre, at alle batches af lægemidlet er af dokumenteret kvalitet.
English: Amount of non-clinical data determined by the outcome of quality studies
Danish: Mængden af non-kliniske data bestemmes af resultaterne af kvalitetsstudierne
English: Harmful immunogenicity is unlikely after manufacturing changes or after switching
Danish: Skadelig immunogenicitet er ikke sandsynligt efter ændringer af fremstillingen eller efter skift
English: Weise M, Bielsky MC, De Smet K, et al. Biosimilars: what clinicians should know.
Danish: Weise M, Bielsky MC, De Smet K, m.fl. Biosimilars: what clinicians should know.
English: The list of INNs, which is globally recognised and public property, is maintained by WHO.
Danish: Listen over INN-navne, som er internationalt anerkendte og offentlig ejendom, føres af WHO.
English: Good manufacturing practice
Danish: God produktionspraksis
English: Monitoring long-term or long-latency adverse events
Danish: Overvågning af negative hændelser på langt sigt eller med lang latenstid
English: Prepared jointly by the European Medicines Agency and the European Commission
Danish: Udarbejdet af Det Europæiske Lægemiddelagentur og Europa-Kommissionen i fællesskab
English: This guide was last updated on 02/10/2019
Danish: Denne håndbog er senest ajourført den 02/10/2019
English: Of more than 50 biosimilars approved in the EU to date, none has been withdrawn or suspended for reasons of safety or efficacy.
Danish: Ingen af de over 50 biosimilære lægemidler, som er godkendt i EU indtil nu, er blevet tilbagekaldt eller suspenderet på grund af sikkerhed eller virkning.
English: Studies of the biochemical and physiological effects of a medicine in the body, including mechanism of action.
Danish: Studier af de biokemiske og fysiologiske effekter af et lægemiddel i kroppen, herunder virkningsmekanisme.
English: Complexity of the molecule and comparability data available
Danish: Molekylets kompleksitet og tilgængelige sammenlignelighedsdata
English: A robust regulatory framework to protect patients' safety
Danish: En robust lovramme for at styrke patientsikkerheden
English: Where applicable, the assessment report also includes the scientific rationale for extrapolation of data.
Danish: Om nødvendigt indeholder vurderingsrapporten også den videnskabelige begrundelse for ekstrapolering af data.
English: EMA continues to share the extensive experience gained in the EU on biosimilars with other regulators around the world and participates in a number of international forums such as the International Pharmaceutical Regulators Forum.
Danish: EMA deler fortsat sine omfattende erfaringer med biosimilære lægemidler i EU med andre regukatoriske myndigheder rundt om i verden og deltager i en række internationale fora som f.eks. International Pharmaceutical Regulators Forum.
English: Food and Drug Administration (the US medicines regulatory authority)
Danish: Food and Drug Administration (den amerikanske regulerende myndighed for lægemidler)
English: ADAs against a medicine can result in loss of efficacy or in immunological reactions.
Danish: ADA mod et lægemiddel kan resultere i tab af virkning eller immunologiske reaktioner.
English: Safety concerns with the reference medicine or pharmacological class
Danish: Sikkerhedsproblemer med referencelægemidlet eller den farmakologiske klasse
English: The expertise acquired over the last 10 years has enabled EU regulators to integrate experience-based knowledge with the initial sciencedriven concept.
Danish: Den ekspertise, der er opbygget i løbet af de sidste 10 år, har gjort det muligt for EU's lovgivningsmyndigheder at integrere den erfaringsbaserede viden med det oprindelige videnskabeligt baserede koncept.
English: When a new medicine is approved by EMA, the Agency also publishes a summary for the general public explaining why the medicine is approved in the EU.
Danish: Når et nyt lægemiddel godkendes af EMA, offentliggør EMA også et resumé til offentligheden, som forklarer, hvorfor lægemidlet godkendes i EU.
English: This list includes medicines authorised in the EU that are being monitored particularly closely by regulatory authorities, for example because the active substance is new to the market or there are limited data on its long-term use.
Danish: Denne liste omfatter lægemidler, der er godkendt i EU, og som overvåges særligt nøje af de regulerende myndigheder, f.eks. fordi det virksomme stof er nyt på markedet eller der kun er begrænsede data om langsigtet brug.
English: In the EU, prescribing practices and advice to prescribers fall under the responsibility of Member States, which have the necessary legal framework in place and issue regulations, guidelines and advice in their areas of competence.
Danish: I EU hører ordineringspraksis og rådgivning til ordinerende læger ind under medlemsstaternes ansvarsområde, da de har de nødvendige lovrammer og udsteder regler, retningslinjer og rådgivning inden for deres kompetenceområder.
English: When two medicines release the same active substance into the body at the same rate and to the same extent under similar conditions.
Danish: Når to lægemidler frigiver det samme virksomme stof i kroppen med samme hastighed og i samme omfang på lignende betingelser.
English: The review by EMA results in a scientific opinion, which is then sent to the European Commission, which ultimately grants an EU-wide marketing authorisation.
Danish: EMA's gennemgang udmøntes i en videnskabelig udtalelse, der sendes til Europa-Kommissionen, som i sidste ende udsteder en markedsføringstilladelse for hele EU.
English: How healthcare professionals can help improve pharmacovigilance for biological medicines:
Danish: Hvordan sundhedspersoner kan bidrage til at forbedre lægemiddelovervågningen for biologiske lægemidler:
English: These WHO guidelines incorporate many of the scientific principles used by EMA and its scientific committees in EU guidelines, as EU experts have been closely involved in the preparation of the WHO guidelines.
Danish: WHO's retningslinjer indeholder mange af de videnskabelige principper, som anvendes af EMA og dets videnskabelige udvalg i EU's retningslinjer, da EUeksperter har været tæt involveret i udarbejdelsen af WHO's retningslinjer.
English: Clinical trials are needed only if an impact on safety and efficacy is anticipated (scenario 3).
Danish: Kliniske forsøg er kun påkrævet, hvis der forventes en påvirkning af sikkerheden og effektiviteten (scenarie 3).