FrancophonIA/ELRC3.0 huggingface dataset:
English: EMA/837288/2016 Rev.1 EMEA/H/A-30/1429
Danish: EMA/837288/2016 EMEA/H/A-30/1429
English: It is also available under other trade names: Clexane, Clexane T, Clexane Forte, Klexane, Qualiop, Enoxaparin Sanofi and Enoxaparine Sanofi.
Danish: Det markedsføres også under andre handelsnavne: Clexane, Clexane T, Clexane Forte, Klexane, Qualiop, Enoxaparin Sanofi og Enoxaparine Sanofi.
English: What is Lovenox?
Danish: Hvad er Lovenox?
English: The regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and of the risk of bleeding.
Danish: Dosisregimet bør vælges af lægen efter en individuel vurdering, herunder vurdering af den tromboemboliske risiko og blødningsrisikoen.
English: On 15 December 2016, the European Medicines Agency completed a review of Lovenox and associated names.
Danish: Den 15. december 2016 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af Lovenox og relaterede navne.
English: The CHMP agreed that the strength of the active substance enoxaparin will now be expressed both in international units (IU) and in milligram (mg) throughout the product information.
Danish: CHMP var enig i, at det aktive stof, enoxaparin, nu vil blive angivet både i internationale enheder (IE) og i mg i al produktinformation.
English: The CHMP agreed that Lovenox can be used for the following uses:
Danish: CHMP vedtog, at Lovenox kan anvendes til:
English: The Committee also harmonised other sections of the SmPC including sections 4.4 (special warning and precautions), 4.5 (interaction with other medicinal products and other forms of interaction), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use of machines) and 4.8 (undesirable effects).
Danish: Udvalget harmoniserede derudover andre afsnit i produktresuméet, herunder 4.4 (særlige advarsler og forsigtighedsregler vedrørende brugen), 4.5 (interaktion med andre lægemidler og andre former for interaktion), 4.6 (frugtbarhed, graviditet og amning), 4.7 (virkning på evnen til at føre motorkøretøj og betjene maskiner) og 4.8 (bivirkninger).
English: • to treat certain types of myocardial infarction (heart attack);
Danish: • at behandle visse typer af hjerteanfald (myokardieinfarkt)
English: Lovenox is authorised in the EU via national procedures.
Danish: Lovenox blev godkendt i EU via nationale procedurer.
English: Why was Lovenox reviewed?
Danish: Hvorfor blev Lovenox vurderet igen?
English: Questions and answers on Lovenox and associated names (enoxaparin, solution for injection)
Danish: Spørgsmål og svar vedrørende Lovenox og relaterede navne (enoxaparin til injektion)
English: For the treatment of deep vein thrombosis and pulmonary embolism, the CHMP also clarified that the dose regimen of 150 IU/kg (1.5 mg/kg) given once daily should only be used only in uncomplicated patients who have a low risk of a further venous thromboembolism.
Danish: Med hensyn til behandling af dyb venetrombose og lungeemboli og forebyggelse af tilbagefald præciserede CHMP også, at dosisregimet på 150 IE /kg (1,5 mg/kg) en gang dagligt kun bør anvendes til patienter, som har en lav risiko for at udvikle en yderligere venøs tromboemboli.
English: On 12 November 2015, France referred the matter to the CHMP in order to harmonise the marketing authorisations for Lovenox in the EU.
Danish: Den 12. november 2015 henviste Europa-Kommissionen sagen til CHMP med henblik på harmonisering af markedsføringstilladelserne for Lovenox i EU.
English: • to prevent clots forming when blood is circulated through a haemodialysis machine to remove toxic substances.
Danish: • at forebygge, at der dannes blodpropper, når blodet løber gennem en dialysemaskine for at få fjernet giftige stoffer.
English: Lovenox contains the active substance enoxaparin.
Danish: Det indeholder det aktive stof enoxaparin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Lovenox in the European Union (EU).
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for harmonisering af produktinformationen for Lovenoxi i Den Europæiske Union (EU).
English: Lovenox is available in all EU countries.
Danish: Lovenox er godkendt i alle EU's medlemsstater.
English: This section was also updated to reflect that outside its approved use in haemodialysis Lovenox is not recommended in patients with end stage kidney disease.
Danish: Indholdet i dette afsnit blev desuden opdateret for at afspejle, at Lovenox er godkendt til anvendelse ved hæmodialyse, men frarådes til anvendelse hos patienter med terminal nyresygdom.
English: Lovenox is an anticoagulant medicine (a medicine to prevent blood clots) used in adults to prevent and treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg), as well as unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart) and certain types of myocardial infarction (heart attack);
Danish: Lovenox er et antikoagulerende lægemiddel (lægemiddel til forebyggelse af blodpropper), som anvendes hos voksne til forebyggelse og behandling af lidelser, der er forbundet med blodpropper, f.eks. dyb venetrombose (hvor blodproppen opstår i en dyb blodåre, typisk i benet) og ustabil angina (en alvorlig type brystsmerter, der skyldes problemer med blodtilførslen til hjertet) samt visse typer af myokardieinfarkt (hjerteanfald)
English: It is available as vials, ampoules, prefilled syringes and pens and is given by injection under the skin or into a vein.
Danish: Det fås som hætteglas, fyldte sprøjter og penne og gives om en injektion under huden eller i en vene.
English: A contraindication that existed in some EU member states for use in patients with severe kidney impairment was removed.
Danish: En kontraindikation i nogle medlemsstater hos patienter med svært nedsat nyrefunktion blev slettet fra produktinformationen.
English: • to treat conditions associated with blood clots such as deep vein thrombosis (where the clot develops in a deep vein, usually in the leg) or pulmonary embolism (clot in a blood vessel supplying the lung);
Danish: • at behandle lidelser, der er forbundet med blodpropper, f.eks. dyb venetrombose (hvor blodproppen opstår i en dyb blodåre, typisk i benet) eller lungeemboli (blodprop i et blodkar,
English: • to prevent venous thromboembolism (blood clots that form inside the veins, obstructing blood flow), especially in patients who are having surgery or who are at greater risk of clots because they have reduced mobility due to illness;
Danish: (venøs tromboembolisme), navnlig hos patienter, der skal opereres, eller som har en større risiko for blodpropper, fordi deres mobilitet er nedsat på grund af sygdom
English: • to treat unstable angina (a severe type of chest pain caused by problems with the blood flow to the heart);
Danish: • at behandle en alvorlig type brystsmerter, der skyldes problemer med blodtilstrømningen til hjertet (ustabil angina pectoris)
English: Lovenox was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Danish: Koordinationsgruppen vedrørende gensidig anerkendelse og decentral procedure - lægemidler til mennesker (CMDh) fandt, at det er nødvendigt at harmonisere Lovenox.
English: This document presents the conclusions on aprotinin.
Danish: Dette dokument fremlægger konklusionerne for aprotinin.
English: All risks should be captured in the risk management plan.
Danish: Alle risici skal medtages i risikostyringsplanen.
English: Divergent positions are appended to the Opinion.
Danish: Divergerende positioner tilføjes udtalelsen.
English: In addition, results from observational studies are conflicting.
Danish: Derudover er resultaterne af observationsundersøgelser modstridende.
English: In this regard, a study on the profile of aprotinin use is needed, particularly in light of the importance of adequate anticoagulation.
Danish: I denne henseende er der er behov for en undersøgelse om aprotinins anvendelsesprofil, navnlig i lys af vigtigheden af tilstrækkelig antikoagulation.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC, for aprotinin, aminocaproic acid and tranexamic acid (see Annex I).
Danish: • Udvalget overvejede proceduren under artikel 31 i direktiv 2001/83/EF for aprotinin, aminocapronsyre og tranexamsyre (se bilag I).
English: The quality review of documents templates were taken into account during this review.
Danish: Den seneste kvalitetsvurdering af dokumentskabelonerne blev taget i betragtning under dette gennemsyn.
English: All risks of aprotinin known to date were considered.
Danish: Alle de hidtil kendte risici ved aprotinin blev gennemgået.
English: The conditions with regard to the safe and effective use of the medicinal product to be implemented by the member states are set out in annex IV of the opinion.
Danish: Betingelserne vedrørende sikker og effektiv anvendelse af lægemidlet, der skal implementeres af medlemslandene, fremgår af bilag IV til udtalelsen.
English: Anaphylactic reactions are another well-known adverse effect that primarily occurs after repeated treatment.
Danish: Anafylaktiske reaktioner er en anden velkendt bivirkning, der primært forekommer efter gentagen behandling.
English: In case of repeated treatment, physicians should be aware of the risk, and manage their patients adequately.
Danish: I tilfælde af gentagen behandling bør læger være opmærksomme på denne risiko og behandle den aktuelle patient tilstrækkeligt.
English: In the initial review in 2007 concerns had also been raised by the findings of three observational studies.
Danish: Under den indledende gennemgang i 2007 blev der også påpeget problemer ved resultaterne af tre observationsundersøgelser.
English: The CHMP noted the uncertainties and advised that the interpretation of all available data from observational studies is limited.
Danish: CHMP tog usikkerheden til efterretning og informerede om, at fortolkningen af alle foreliggende data fra observationsundersøgelser er begrænset.
English: Sufficient evidence of efficacy in this patient population is available.
Danish: Virkningen hos denne patientpopulation er tilstrækkeligt dokumenteret.
English: In addition, aprotinin should be used only in adult patients (data in children are not available) who are at ‘high-risk' of major blood loss.
Danish: Desuden bør aprotinin kun anvendes hos voksne patienter (der foreligger ikke data for børn) med “høj risiko“ for større blodtab.
English: There are no indications that the efficacy would vary by age or that the safety pattern of aprotinin would be different in elderly patients as compared to the overall study populations.
Danish: Der er ingen tegn på, at virkningen varierer med alderen, eller at sikkerhedsmønsteret af aprotinin er anderledes hos ældre patienter end hos den undersøgte population som helhed.
English: The registry, which will be mandatory for use of the product, will monitor the pattern of use in participating countries and record utilisation information.
Danish: Registreret vil være obligatorisk ved anvendelse af produktet og skal overvåge anvendelsesmønstret i de deltagende lande og registrere oplysninger om anvendelsen.
English: The number of patients who receive aprotinin, indication for administration, patient characteristics and risk factors and conditions of use including data on heparinisation of patients treated with aprotinin are some of the information to be collected.
Danish: Antallet af patienter, som får aprotinin, indikationen for administration, patientkarakteristika og -risikofaktorer samt anvendelsesbetingelser, herunder data om heparinisering af aprotininbehandlede patienter, er blandt de oplysninger, der skal indsamles.
English: Re-surgery due to bleeding carries high risk for increased morbidity which also was emphasised by the group of external experts consulted by the CHMP.
Danish: Reoperation på grund af blødning indebærer høj risiko for øget dødelighed, hvilket også blev understreget af den eksterne ekspertgruppe, der blev konsulteret af CHMP.
English: Overall summary of the scientific evaluation of referral on antifibrinolytics Aprotinin containing medicinal products (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af indbringelse af antifibrinolytika Lægemidler, der indeholder aprotinin (se bilag I)
English: The MAHs will submit a revised protocol for the registry to national competent authorities.
Danish: Indehaverne af markedsføringstilladelserne skal indsende en revideret protokol for registeret til de nationale kompetente myndigheder.
English: • The Committee considered that the product information should be updated to ensure that the information to healthcare professionals and patients is up-to-date.
Danish: • Udvalget bemærkede, at produktoplysningerne skal opdateres for at sikre, at informationen til sundhedspersonale og patienter er opdateret.
English: The product has been used outside its indication, with several trials where risks were observed conducted in a wider patient population.
Danish: Produktet er blevet anvendt uden for sin indikation, og der er fundet risici i adskillige undersøgelser, som omfattede en bredere patientpopulation.
English: Recommendations on adequate monitoring of the anticoagulative effect of heparin administered in the CABG procedure should be reflected in the product information.
Danish: Anbefalinger om tilstrækkelig overvågning af den antikoagulerende virkning af heparin, der administreres under CABG, bør oplyses i produktoplysningerne.
English: The CHMP considered that all of these risks, along with the uncertainties on the findings from clinical trials and observational studies on mortality, should be appropriately reflected through warnings and recommendations in the product information and captured in the risk management plan.
Danish: CHMP fandt, at alle disse risici sammen med alle usikkerhederne ved resultaterne fra kliniske undersøgelser og observationsundersøgelser af dødeligheden bør oplyses korrekt i advarsler og anbefalinger i produktoplysningerne og medtages i risikostyringsplanen.
English: Aprotinin should only be used after careful consideration of the benefits and risks, and the consideration that alternative treatments are available (see section 4.4 and 5.1).
Danish: Aprotinin bør kun anvendes efter nøje overvejelse af fordele og risici, og om der er mulighed for andre behandlinger (se pkt.
English: The CHMP considered that overall the data provided illustrate the risks associated with inadequate monitoring of the anticoagulative effect of heparin administered in the CABG procedure.
Danish: CHMP fandt, at de indsendte data samlet set illustrerer de risici, der er associeret med utilstrækkelig overvågning af den antikoagulerende virkning af heparin, som administreres under CABG.
English: Therefore the CHMP concluded that the balance of risks and benefits for aprotinin is positive under normal conditions of use subject to the revision of the indication as follows:
Danish: Derfor konkluderede CHMP, at benefit/risk-forholdet for aprotinin er positivt under normale betingelser for anvendelse, under forudsætning af en revision af indikationerne som følger:
English: The final results of BART study have since become available, together with important new analysis of the study data.
Danish: De endelige resultater af BART-undersøgelsen er siden blevet forelagt samme med en vigtig ny analyse af undersøgelsesdataene.
English: No firm conclusion on cardiovascular risks can be made on the BART study due to several serious methodological issues identified.
Danish: Der kan ikke drages en fast konklusion vedrørende kardiovaskulære risici på grundlag af BART-undersøgelsen på grund af adskillige, alvorlige identificerede metodefejl.
English: A comprehensive review was undertaken and the CHMP concluded that the final BART study results were seriously compromised by several newly identified major methodological deficiencies, which were considered crucial to the validity and interpretation of the results.
Danish: Der blev foretaget en omfattende gennemgang, og CHMP konkluderede, at de endelige resultater af BART-undersøgelsen var stærkt behæftet med adskillige nyidentificerede store metodefejl, der blev anset for at være afgørende for gyldigheden og fortolkningen af resultaterne.
English: The new data available to date however showed that the indication, and other sections of the product information, merited change, to take due account of known risks and the uncertainties associated with such risks.
Danish: De nye data, der er blevet tilgængelige indtil nu, viser imidlertid, at der er behov for at ændre indikationen og andre dele af produktoplysningerne for at tage behørigt hensyn til de kendte risici og de dermed forbundne usikkerheder.
English: Other notable safety concerns include the identified risk for transient renal impairment, which is a well characterised unfavourable effect of treatment with aprotinin.
Danish: Andre vigtige sikkerhedsproblemer omfatter den identificerede risiko ved midlertidigt nedsat nyrefunktion, som er en velkarakteriseret uønsket virkning ved behandling med aprotinin.
English: This is important to take into consideration when treating patients with known pre-existing impairment and in patients concomitantly treated with drugs that may affect renal function.
Danish: Dette er vigtigt at tage i betragtning ved behandling af patienter med kendt, eksisterende nedsat nyrefunktion og hos patienter i samtidig behandling med lægemidler, der kan påvirke nyrefunktionen.
English: • The Committee considered all data provided by the MAHs in writing and at the oral explanation, including data available from literature reviews and the outcome of a scientific advisory group.
Danish: • Udvalget tog hensyn til alle data, der er forelagt af indehaverne af markedsføringstilladelserne skriftligt og ved den mundtlige fremlæggelse, herunder data fra litteraturgennemgange og fra en videnskabelig rådgivende gruppe.
English: The marketing authorisations for aprotinin were suspended following the preliminary results of the BART study in 2007, and concerns raised over some observational studies.
Danish: Markedsføringstilladelserne for aprotinin blev suspenderet efter de foreløbige resultater af BARTundersøgelsen i 2007, og der blev påpeget problemer ved visse observationsundersøgelser.
English: These new data have now made it possible to identify the major flaws of the BART study, not identifiable before.
Danish: Disse nye data har nu gjort det muligt at identificere vigtige fejl ved BART-undersøgelsen, som ikke kunne identificeres tidligere.
English: In addition, a registry must be conducted by MAHs of aprotinin containing medicinal products in order to gather more information on the profile of aprotinin use.
Danish: Derudover skal der oprettes et register over indehavere af markedsføringstilladelser til lægemidler, der indeholder aprotinin, for at samle mere information om anvendelse af aprotinin.
English: Several data sources informed the opinion of the Committee, including available data from clinical studies, published literature, spontaneous reports and other data submitted by marketing authorisation holders (MAHs) of medicinal products containing aprotinin, EACA or TXA.
Danish: Udvalgets udtalelse er baseret på en række datakilder, herunder foreliggende data fra kliniske undersøgelser, offentliggjort litteratur, spontane indberetninger og andre data, der er indsendt af indehaverne af markedsføringstilladelserne for lægemidler indeholdende aprotinin, EACA og TXA.
English: Based on the final results and new evidence from re-analysis of data pointing out the deficiencies of the study that emerged after finalisation of the BART study, the CHMP is of the opinion that these data are not reliable and cannot be considered with regards to the cardiovascular risks of aprotinin.
Danish: På grundlag af de endelige resultater og ny evidens fra reanalyse af dataene, der klarlagde fejlene ved undersøgelsen efter fuldførelse af BART-undersøgelsen, fandt CHMP, at disse data ikke er pålidelige og ikke kan tages i betragtning vedrørende de kardiovaskulære risici ved aprotinin.
English: The observational studies have provided conflicting results related to mortality as discussed above.
Danish: Som omhandlet ovenfor har observationsundersøgelserne givet modstridende resultater vedrørende mortalitet.
English: The deficiencies included the unexplained exclusion of patients from analysis, underlying differences in baseline characteristics between the study groups which were not homogenous in spite of randomisation, and the apparent reduced level of heparinisation in the aprotinin arm which would increase the risk of thrombogenic events in this group.
Danish: Fejlene omfattede en uforklaret udelukkelse af patienter fra analysen, underliggende forskelle i baselinekarakteristika mellem undersøgelsens grupper, som trods randomisering ikke var homogene, og det tilsyneladende nedsatte niveau af heparinisering i aprotininarmen, som må forventes at give øget risiko for trombogene hændelser i denne gruppe.
English: The scientific conclusions and the grounds for the lifting of the suspension and amendment of the marketing authorisation are set out in annex II of the opinion.
Danish: De videnskabelige konklusioner og begrundelserne for ophævelse af suspenderingen og ændring af markedsføringstilladelsen fremgår af bilag II til udtalelsen.
English: • The Committee concluded that evidence from randomised clinical trials and observational studies support the use of aprotinin in reducing the incidence of massive bleeding, the need for transfusion of blood products and the need for re-surgery for bleeding.
Danish: • Udvalget konkluderede, at evidens fra randomiserede, kliniske undersøgelser og observationsundersøgelser støtter anvendelsen af aprotinin til reduktion af forekomsten af massiv blødning, behovet for transfusion af blodprodukter og behovet for reoperation på grund af blødning.
English: • The CHMP concluded that the BART data and the signal on increased mortality associated with aprotinin compared to EACA and TXA were not considered reliable, based on the totality of evidence now available since the review of aprotinin undertaken in 2007, including more recent observational studies, the new analyses of the BART study data and the identified major study flaws, and taking the advice of the SAG into account.
Danish: • CHMP konkluderede, at data fra BART-undersøgelsen og tegn på øget dødelighed associeret med aprotinin sammenlignet med EACA og TXA ikke kunne anses som pålidelige på grundlag af al evidens, der er fremkommet siden gennemgangen af aprotinin i 2007, herunder nyere observationsundersøgelser, de nye analyser af dataene fra BART-undersøgelsen og de identificerede vigtige fejl ved undersøgelsen, og rådgivning fra SAG taget i betragtning.
English: Special attention is also to be given to patients with renal impairment and to the possible occurrence anaphylactic reactions.
Danish: Der skal også udvises særlig opmærksomhed ved patienter med nedsat nyrefunktion og for den mulige forekomst af anafylaktiske reaktioner.
English: A direct healthcare professional communication (DHPC) was agreed to provide prescribers with information on the review and an update on the safety information for aprotinin.
Danish: Det blev besluttet at udsende en DHPC-meddelelse (direkte meddelelse til fagfolk i sundhedssektoren) til receptudstedere med information om denne gennemgang og en opdatering af sikkerhedsinformationen for aprotinin.
English: As a result, the Committee agreed on the lifting of the suspension for aprotinin with the balance of risks and benefits considered positive in the following revised indication for aprotinin:
Danish: Som følge heraf indvilgede udvalget i ophævelse af suspenderingen af aprotinin med et benefit/riskforhold, der blev anset som positivt, i følgende reviderede indikation for aprotinin: