FrancophonIA/ELRC3.0 huggingface dataset:
English: The octocog alfa in these products has the same structure as natural factor VIII (‘full-length').
Danish: Octocog alfa i disse produkter har samme struktur som naturlig faktor VIII (“fuld længde”).
English: Benefits continue to outweigh risks in previously untreated patients
Danish: Fordelene opvejer fortsat risiciene hos tidligere ubehandlede patienter
English: In this study, the incidence of inhibitor development ranged from 28.2% to 37.7% for all products.
Danish: I undersøgelsen var forekomsten af inhibitordannelse mellem 28,2 % og 37,7 % for alle produkter.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the Agency's final opinion.
Danish: Anbefalingerne fra PRAC blev overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse.
English: The CHMP considered the PRAC recommendations and agreed by consensus that they should be implemented.
Danish: CHMP gennemgik PRAC's anbefalinger og vedtog enstemmigt, at de burde gennemføres.
English: The review of Kogenate Bayer and Helixate NexGen was initiated on 5 March 2013 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Danish: Gennemgangen af Kogenate Bayer og Helixate NexGen blev indledt den 5. marts 2013 på anmodning af Europa-Kommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004.
English: Alternative products containing various forms of factor VIII are available and may be used similarly.
Danish: Der findes andre produkter med forskellige former for faktor VIII, som kan anvendes på tilsvarende måde.
English: CHMP confirms PRAC recommendations on Kogenate Bayer/Helixate NexGen
Danish: CHMP bekræfter PRAC's anbefalinger for Kogenate Bayer/Helixate NexGen
English: • However, when all the evidence was assessed, including that from this study, there was not enough to support a genuine difference between the products.
Danish: • Ved en samlet vurdering af alle resultater, herunder denne undersøgelse, blev oplysningerne dog fundet utilstrækkelige til, at der kunne antages at være en egentlig forskel mellem produkterne.
English: They contain a form of factor VIII, octocog alfa, produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced which makes them able to produce the clotting factor.
Danish: De indeholder en form for faktor VIII, octocog alfa, der fremstilles ved “rekombinant DNA-teknologi”: Den produceres af celler, der har fået indsat et gen (DNA), som gør dem i stand til at producere koagulationsfaktoren.
English: In patients given Kogenate Bayer/Helixate NexGen, the incidence of inhibitor development was 64/183 (37.7%) when followed for up to 75 exposure days, of whom 40 had a high-titre inhibitor (25.2%).
Danish: Af de patienter, der fik Kogenate Bayer/Helixate NexGen, dannede 64 ud af 183 inhibitor (37,7 %) ved opfølgning i indtil 75 eksponeringsdage; heraf havde 40 inhibitor med høj titer (25,2 %).
English: However the product information has been updated to reflect the study results and ensure that healthcare professionals treating patients with haemophilia A are aware of them.
Danish: Produktinformationen er dog blevet ajourført, så den afspejler undersøgelsesresultaterne og sikrer, at de kendes af de sundhedspersoner, der behandler patienter med hæmofili A.
English: The frequency of inhibitor development in previously untreated patients has been amended in line with the current evidence to ‘very common'.
Danish: Hyppigheden af inhibitordannelse hos tidligere ubehandlede patienter er blevet rettet til “meget almindelig” i overensstemmelse med den nuværende evidens.
English: Kogenate Bayer and Helixate NexGen are identical medicines that were authorised throughout the European Union (EU) on 4 August 2000.
Danish: Kogenate Bayer og Helixate NexGen er to ens lægemidler, som blev godkendt i hele Den Europæiske Union (EU) den 4. august 2000.
English: • Quality data presented by the marketing authorisation holder also indicated that the biophysical and biochemical characteristics of Kogenate Bayer and Helixate Nexgen have not significantly changed since the initial marketing authorisation.
Danish: • De data om kvalitet, der var forelagt af indehaveren af markedsføringstilladelsen, viste endvidere, at de biofysiske og biokemiske egenskaber af Kogenate Bayer og Helixate Nexgen ikke har ændret sig nævneværdigt siden den oprindelige markedsføringstilladelse.
English: • Kogenate Bayer and Helixate NexGen can continue to be prescribed and used as appropriate in the management of haemophilia A. Existing risk minimisation measures are considered adequate and should be continued.
Danish: • Kogenate Bayer og Helixate NexGen kan fortsat ordineres og anvendes korrekt til behandling af hæmofili A. De eksisterende risikominimeringsforanstaltninger anses for tilstrækkelige og bør bibeholdes.
English: These antibodies (factor VIII inhibitors) reduce the effectiveness of the medicine and make bleeding more likely.
Danish: Disse antistoffer (faktor VIII-inhibitorer) nedsætter lægemidlets virkning og øger sandsynligheden for blødning.
English: • In addition, the product information for Kogenate Bayer and Helixate NexGen has been updated to reflect the results of the RODIN/PedNet study.
Danish: • Derudover er produktinformationen for Kogenate Bayer og Helixate NexGen blevet ajourført, så den afspejler resultaterne af RODIN/PedNet-undersøgelsen.
English: The benefits of treatment with Kogenate Bayer or Helixate NexGen continue to outweigh their risks in previously untreated patients.
Danish: Fordelene ved behandling med Kogenate Bayer eller Helixate NexGen opvejer fortsat risiciene hos tidligere ubehandlede patienter.
English: These may be extracted from human blood (‘plasma-derived'), produced as full-length recombinant products with varying degrees of exposure to other blood-derived proteins (first, second, or third generation), or may contain a shortened, but still active, recombinant form of the factor VIII molecule.
Danish: Der er dels tale om produkter udvundet af blod fra mennesker (“plasmaderiverede”), dels fremstillet som rekombinante produkter i fuld længde med forskellige grader af eksponering for andre blodderiverede proteiner (første-, anden- eller tredjegenerationsprodukter), dels indeholdende en afkortet, men stadig aktiv rekombinant form af faktor VIII-molekylet.
English: • Concerns about a potentially increased risk of factor VIII inhibitor development with full-length second generation factor VIII products were originally raised by the RODIN/PedNet study.
Danish: • Betænkelighederne ved en potentielt øget risiko for udvikling af faktor VIII-inhibitor med andengenerations faktor VIII-produkter af fuld længde var oprindeligt foranlediget af RODIN/PedNet-undersøgelsen.
English: The CHMP opinion was then sent to the European Commission, which endorsed it and issued an EU-wide legally binding decision on 20 February 2014.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som godkendte den og vedtog en afgørelse, der er retligt bindende i hele EU, den 20. februar 2014.
English: Kogenate Bayer and Helixate NexGen are known as second generation factor VIII products.
Danish: Kogenate Bayer og Helixate NexGen betegnes som andengenerations faktor VIII-produkter.
English: On 20 December 2013 the European Medicines Agency's Committee on Human Medicinal Products (CHMP) endorsed previous recommendations which concluded that the benefits of Kogenate Bayer and Helixate NexGen, so-called second generation factor VIII products, continue to outweigh their risks in previously untreated patients with the bleeding disorder haemophilia A, but that the product information for these medicines should be amended.
Danish: Den 20. december 2013 vedtog Det Europæiske Lægemiddelagenturs Udvalg for Lægemidler til Mennesker (CHMP) de tidligere anbefalinger om, at fordelene ved Kogenate Bayer Helixate NexGen, der er såkaldte andengenerations faktor VIII-produkter, fortsat opvejer risiciene hos tidligere ubehandlede patienter med blødningsforstyrrelsen hæmofili A, men at produktinformationen for disse lægemidler bør ændres.
English: The Agency's recommendations are based on the results of the RODIN/PedNet study, preliminary findings from the European Haemophilia Safety Surveillance System (EUHASS) and all available data submitted from clinical trials, observational studies, published literature and quality data for Kogenate Bayer and Helixate NexGen with regards to its potential risk of inhibitor development in previously untreated patients (PUPs).
Danish: Agenturets anbefalinger er baseret på resultaterne af RODIN/PedNet-undersøgelsen, de indledende resultater fra det europæiske register til sikkerhedsovervågning ved hæmofili (EUHASS) og alle foreliggende data fra kliniske observationsundersøgelser, den publicerede litteratur og data vedrørende kvalitet for Kogenate Bayer og Helixate NexGen hvad angår den potentielle risiko for inhibitordannelse hos tidligere ubehandlede patienter.
English: About a third of all the children in the RODIN study developed factor VIII inhibitors against their medicine, which reduces the benefit and makes bleeding more likely.
Danish: Ca. en tredjedel af alle børnene i RODIN-undersøgelsen dannede faktor VIII-inhibitorer mod deres lægemiddel, hvilket medfører forringet behandlingsfordel og øget blødningstendens.
English: An increase in inhibitor formation was not seen with other recombinant or plasma-derived factor VIII products.
Danish: Der sås ikke stigning i inhibitordannelse med andre rekombinante eller plasmaderiverede faktor VIII-produkter.
English: • Different forms of factor VIII are available as medicines to replace the missing clotting factor.
Danish: • Der findes lægemidler med forskellige former af faktor VIII, som kan erstatte den manglende koagulationsfaktor.
English: The CHMP opinion was forwarded to the European Commission, which endorsed it and issued a final legally binding decision, valid across the EU, on 20 February 2014.
Danish: CHMP's udtalelse blev overgivet til Europa-Kommissionen, som godkendte den og den 20. februar 2014 vedtog en endelig beslutning med gyldighed i hele EU.
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Danish: Tlf. +44 (0)20 7418 8427
English: • Haemophilia A is an inherited bleeding disorder in which there is a lack of factor VIII, which is needed for blood to clot normally.
Danish: • Hæmofili A er en arvelig blødningsforstyrrelse, der skyldes mangel på faktor VIII, som er nødvendig for at blodet kan størkne normalt.
English: • However, when all the available data were considered, they were consistent with the general clinical experience that most inhibitors develop within the first 20 days of exposure and that factor VIII products did not differ from each other in terms of inhibitor development in PUPs.
Danish: • PRAC fandt imidlertid, at når alle de foreliggende data toges i betragtning, var de i overensstemmelse med den almindelige kliniske erfaring, nemlig at de fleste inhibitorer dannes i løbet af de første 20 eksponeringsdage, og at faktor VIII-produkter ikke afviger indbyrdes med hensyn til inhibitordannelse hos tidligere ubehandlede patienter.
English: • Despite concerns raised by the RODIN/PedNet study, overall the current evidence does not confirm that there is an increased risk of inhibitor development against full-length second generation factor VIII products such as Kogenate Bayer and Helixate NexGen.
Danish: • Trods de betænkeligheder, som RODIN/PedNet-undersøgelsen gav anledning til, kan den foreliggende evidens overordnet ikke bekræfte en større risiko for inhibitordannelse mod andengenerations faktor VIII-produkter i fuld længde såsom Kogenate Bayer og Helixate NexGen.
English: They are used to replace the factor VIII that is lacking in patients with haemophilia A, an inherited bleeding disorder.
Danish: Det anvendes som erstatning for den manglende faktor VIII hos patienter med hæmofili A, der er en arvelig blødningsforstyrrelse.
English: This is a known risk for all factor VIII products but the authors of the study concluded that children given so-called second generation fulllength recombinant factor VIII products such as Kogenate Bayer or Helixate NexGen were more likely to develop antibodies than those given a third generation recombinant product.
Danish: Dette er en kendt risiko ved alle faktor VIII-produkter, men undersøgelsens forfattere konkluderede, at de børn, der fik de såkaldte andengenerations rekombinante faktor VIII-produkter med fuld længde, såsom Kogenate Bayer eller Helixate NexGen, var mere tilbøjelige til at danne antistoffer end de, der fik et tredjegenerations rekombinant produkt.
English: The review by the PRAC was triggered by results from a study (the RODIN/PedNet study1) in previously untreated children with haemophilia A who were given different factor VIII products, as well as preliminary data from the European Haemophilia Safety and Surveillance System (EUHASS).
Danish: PRAC's gennemgang var foranlediget af resultaterne af en undersøgelse (RODIN/PedNetundersøgelsen1) hos tidligere ubehandlede børn med hæmofili A, der fik forskellige faktor VIIIprodukter, samt foreløbige data fra det europæiske register til sikkerhedsovervågning ved hæmofili (EUHASS).
English: The recommendations, issued by the Agency's Pharmacovigilance Risk Assessment Committee (PRAC), resulted from a review of the medicines which did not confirm a higher risk of developing a type of antibody (factor VIII inhibitors) against these medicines when compared with other factor VIII products.
Danish: Disse anbefalinger blev fremsat af agenturets Udvalg for Risikovurdering inden for Lægemiddelvurdering (PRAC), efter at en gennemgang ikke kunne bekræfte, at der var højere risiko for dannelse af antistoffer af typen faktor VIII-inhibitorer mod disse lægemidler end mod andre faktor VIII-produkter.
English: Post-hoc analysis of the study showed that PUPs with severe haemophilia A given Kogenate Bayer were more likely to develop inhibitors than those given another recombinant antihaemophilic factor VIII (adjusted hazard ratio, 1.60; 95%-CI: 1.08
Danish: Post hoc-analyse af undersøgelsen viste, at de tidligere ubehandlede patienter med svær hæmofili A, der fik Kogenate Bayer, var mere tilbøjelige til inhibitordannelse end de, der fik en anden rekombinant antihæmofilifaktor VIII (justeret risikoforhold 1,60; 95 % SI: 1.08 -2.37).
English: Although existing measures to minimise all the risks from using the products were considered adequate for both Kogenate Bayer and Helixate NexGen and should be continued, the PRAC recommended that the product information should be updated to reflect results from the RODIN study.
Danish: De eksisterende foranstaltninger til risikominimering ved anvendelse af Kogenate Bayer og Helixate NexGen blev anset for tilstrækkelige og burde opretholdes, men PRAC anbefalede, at produktinformationen blev ajourført, så den afspejler resultaterne af RODIN-undersøgelsen.
English: Untreated, the deficiency of factor VIII causes bleeding problems, including bleeding into joints, muscles, and internal organs that can lead to severe damage.
Danish: Uden behandling medfører faktor VIII-mangel blødningsproblemer, herunder blødning i led, muskler og indre organer, som kan medføre svære skader.
English: A study in previously untreated patients with haemophilia A, which compared several of these, seemed to show that patients who were given Kogenate Bayer or Helixate NexGen (full-length second generation products) were more likely to develop antibodies than those given another factor VIII (a third generation product).
Danish: En række af disse lægemidler blev sammenlignet i en undersøgelse, der omfattede tidligere ubehandlede patienter med hæmofili A og syntes at vise, at de patienter, der fik Kogenate Bayer eller Helixate NexGen (andengenerations produkter i fuld længde), var mere tilbøjelige til at danne antistoffer end de, der fik et andet faktor VIII-produkt (et tredjegenerations produkt).
English: This was an observational study which examined inhibitor development in previously untreated patients (PUPs) with severe haemophilia A who were given recombinant or plasma-derived factor VIII products.
Danish: Denne observationsundersøgelse vedrørte inhibitordannelse hos tidligere ubehandlede patienter med svær hæmofili A, som fik rekombinante eller plasmaderiverede faktor VIII-produkter.
English: After reviewing current available data on the development of inhibitors in previously untreated patients, the PRAC decided that these data did not support a conclusion that Kogenate Bayer or Helixate NexGen were associated with an increased risk of developing factor VIII inhibitors compared with other products.
Danish: Efter gennemgang af de foreliggende data om inhibitordannelse hos tidligere ubehandlede patienter afgjorde PRAC, at der ikke var grundlag for at konkludere, at der er større risiko for udvikling af faktor VIII-inhibitorer med Kogenate Bayer eller Helixate NexGen end med andre produkter.
English: Untreated, the deficiency of factor VIII in these patients causes bleeding problems, including bleeding into joints, muscles, and internal organs that can lead to severe damage.
Danish: Ubehandlet medfører faktor VIII-mangel blødningsproblemer, herunder blødning i led, muskler og indre organer, som kan medføre svære skader.
English: Factor VIII is lacking in patients with haemophilia A and is given to them to allow their blood to clot normally.
Danish: Patienter med hæmofili A mangler faktor VIII, som derfor må tilføres, for at blodet kan størkne normalt.
English: This summary was last updated on 18 August 2011.
Danish: Dette sammendrag blev sidst ajourført den 18.08.2011.
English: A second dose may be given after 24 hours if required.
Danish: Om nødvendigt kan der gives endnu en dosis efter 24 timer.
English: The withdrawal period is 15 days for cattle and five days for pigs and horses.
Danish: Tilbageholdelsestiden er 15 dage for kvæg og fem dage for grise og heste.
English: The medicine should not be used in horses producing milk for human consumption.
Danish: Lægemidlet bør ikke anvendes til heste, der producerer mælk til menneskeligt konsum.
English: Milk can be taken five days after administration in cattle.
Danish: Mælken kan anvendes fem dage efter indgivelse hos kvæg.
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Emdocam.
Danish: Personer, som er overfølsomme (allergiske) over for NSAID'er, bør undgå kontakt med Emdocam.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Emdocam to Emdoka bvba on 18 August 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Emdocam til Emdoka bvba den 18.08.2011.
English: In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Danish: I meget sjældne tilfælde kan der opstå anafylaktiske reaktioner, som skal behandles symptomatisk.
English: Other information about Emdocam:
Danish: Andre oplysninger om Emdocam:
English: What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Danish: Hvor lang tid skal der gå, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum (tilbageholdelsestid)?
English: As the prostaglandins trigger inflammation, pain, exudation and fever, meloxicam reduces these clinical signs.
Danish: Da prostaglandiner udløser betændelse, smerter, ekssudation og feber, mindsker meloxicam disse kliniske symptomer.
English: Emdocam is a medicine for cattle, pigs and horses that contains the active substance meloxicam.
Danish: Emdocam er et lægemiddel til kvæg, grise og heste, som indeholder det aktive stof meloxicam.
English: The Committee recommended that Emdocam be given a marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Emdocam.
English: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.
Danish: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: In horses, a transient swelling at the injection site can occur but resolves without intervention.
Danish: Hos heste kan der opstå en forbigående hævelse ved injektionsstedet, som dog forvinder uden behov for indgreb.
English: Emdocam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Danish: Emdocam indeholder meloxicam, som tilhører en gruppe lægemidler, der kaldes non-steroide antiinflammatoriske lægemidler (NSAID'er).
English: No studies in cattle, pigs and horses were required as Emdocam is given by injection and has a similar composition as the reference medicine, Metacam.
Danish: Det var ikke nødvendigt at foretage undersøgelser hos kvæg, grise og heste, da Emdocam gives som injektion og har en sammensætning, der svarer til referencelægemidlet Metacams.
English: It can be used with oral re-hydration therapy for diarrhoea in calves of over one week of age and in young, non-lactating cattle.
Danish: Det kan anvendes sammen med oral rehydreringsbehandling ved diarré hos kalve, der er over en uge gamle, og hos ikke-lakterende ungkvæg.
English: In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Danish: Hos kvæg og grise er subkutan, intramuskulær og intravenøs indgivelse veltolereret, og efter subkutan injektion blev der kun observeret en lille forbigående hævelse ved injektionsstedet hos under 10 % af det behandlede kvæg i de kliniske undersøgelser.
English: It is available as a clear yellow solution for injection (20 mg/ml).
Danish: Det fås som en klar, gul injektionsvæske, opløsning (20 mg/ml).
English: Therefore the CVMP's view was that, as for Metacam, Emdocam's benefits are greater than its risks when used for the approved indications.
Danish: Derfor mente CVMP, at ligesom det er tilfældet med Metacam, er fordelene ved Emdocam større end risiciene, når det anvendes til de godkendte indikationer.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendation for authorisation and the conditions of use.
Danish: Formålet er at forklare, hvordan Udvalget for Veterinærlægemidlers (CVMP) vurdering af den forelagte dokumentation førte til, at man anbefalede at godkende lægemidlet og anvende det som beskrevet nedenfor.
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Danish: Meloxicam virker ved at blokere et enzym kaldet cyclooxygenase, som er med til at danne prostaglandiner.
English: It is used in pigs to reduce the symptoms of lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move) and for the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome), together with appropriate antibiotic therapy.
Danish: Hos grise anvendes det til at reducere symptomerne på halthed og inflammation ved ikke-smitsomme lokomotoriske forstyrrelser (sygdomme, som går ud over bevægeligheden) og til behandling af sygdomme, der opstår efter faring (fødsel), såsom puerperal sepsis og toksikæmi (mastitis-metritisagalaktisk syndrom), sammen med passende antibiotikabehandling.
English: What is the risk associated with Emdocam?
Danish: Hvilken risiko er der forbundet med Emdocam?