natgillin/translations-raw huggingface dataset:
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.
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.
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 %).
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%).
Produktinformationen er dog blevet ajourført, så den afspejler undersøgelsesresultaterne og sikrer, at de kendes af de sundhedspersoner, der behandler patienter med hæmofili A.
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.
Hyppigheden af inhibitordannelse hos tidligere ubehandlede patienter er blevet rettet til “meget almindelig” i overensstemmelse med den nuværende evidens.
The frequency of inhibitor development in previously untreated patients has been amended in line with the current evidence to ‘very common'.
Kogenate Bayer og Helixate NexGen er to ens lægemidler, som blev godkendt i hele Den Europæiske Union (EU) den 4. august 2000.
Kogenate Bayer and Helixate NexGen are identical medicines that were authorised throughout the European Union (EU) on 4 August 2000.
• 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.
• 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.
• 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.
• 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.
Disse antistoffer (faktor VIII-inhibitorer) nedsætter lægemidlets virkning og øger sandsynligheden for blødning.
These antibodies (factor VIII inhibitors) reduce the effectiveness of the medicine and make bleeding more likely.
• Derudover er produktinformationen for Kogenate Bayer og Helixate NexGen blevet ajourført, så den afspejler resultaterne af RODIN/PedNet-undersøgelsen.
• In addition, the product information for Kogenate Bayer and Helixate NexGen has been updated to reflect the results of the RODIN/PedNet study.
Fordelene ved behandling med Kogenate Bayer eller Helixate NexGen opvejer fortsat risiciene hos tidligere ubehandlede patienter.
The benefits of treatment with Kogenate Bayer or Helixate NexGen continue to outweigh their risks in previously untreated patients.
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.
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.
• 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.
• 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.
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.
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.
Kogenate Bayer og Helixate NexGen betegnes som andengenerations faktor VIII-produkter.
Kogenate Bayer and Helixate NexGen are known as second generation factor VIII products.
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.
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.
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.
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).
Ca. en tredjedel af alle børnene i RODIN-undersøgelsen dannede faktor VIII-inhibitorer mod deres lægemiddel, hvilket medfører forringet behandlingsfordel og øget blødningstendens.
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.
Der sås ikke stigning i inhibitordannelse med andre rekombinante eller plasmaderiverede faktor VIII-produkter.
An increase in inhibitor formation was not seen with other recombinant or plasma-derived factor VIII products.
• Der findes lægemidler med forskellige former af faktor VIII, som kan erstatte den manglende koagulationsfaktor.
• Different forms of factor VIII are available as medicines to replace the missing clotting factor.
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.
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.
Tlf. +44 (0)20 7418 8427
Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
• Hæmofili A er en arvelig blødningsforstyrrelse, der skyldes mangel på faktor VIII, som er nødvendig for at blodet kan størkne normalt.
• Haemophilia A is an inherited bleeding disorder in which there is a lack of factor VIII, which is needed for blood to clot normally.
• 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.
• 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.
• 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.
• 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.
Det anvendes som erstatning for den manglende faktor VIII hos patienter med hæmofili A, der er en arvelig blødningsforstyrrelse.
They are used to replace the factor VIII that is lacking in patients with haemophilia A, an inherited bleeding disorder.
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.
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.
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).
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).
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.
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.
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).
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
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.
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.
Uden behandling medfører faktor VIII-mangel blødningsproblemer, herunder blødning i led, muskler og indre organer, som kan medføre svære skader.
Untreated, the deficiency of factor VIII causes bleeding problems, including bleeding into joints, muscles, and internal organs that can lead to severe damage.
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).
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).
Denne observationsundersøgelse vedrørte inhibitordannelse hos tidligere ubehandlede patienter med svær hæmofili A, som fik rekombinante eller plasmaderiverede faktor VIII-produkter.
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.
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.
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.
Ubehandlet medfører faktor VIII-mangel blødningsproblemer, herunder blødning i led, muskler og indre organer, som kan medføre svære skader.
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.
Patienter med hæmofili A mangler faktor VIII, som derfor må tilføres, for at blodet kan størkne normalt.
Factor VIII is lacking in patients with haemophilia A and is given to them to allow their blood to clot normally.
Dette sammendrag blev sidst ajourført den 18.08.2011.
This summary was last updated on 18 August 2011.
Om nødvendigt kan der gives endnu en dosis efter 24 timer.
A second dose may be given after 24 hours if required.
Tilbageholdelsestiden er 15 dage for kvæg og fem dage for grise og heste.
The withdrawal period is 15 days for cattle and five days for pigs and horses.
Lægemidlet bør ikke anvendes til heste, der producerer mælk til menneskeligt konsum.
The medicine should not be used in horses producing milk for human consumption.
Mælken kan anvendes fem dage efter indgivelse hos kvæg.
Milk can be taken five days after administration in cattle.
Personer, som er overfølsomme (allergiske) over for NSAID'er, bør undgå kontakt med Emdocam.
People who are hypersensitive (allergic) to NSAIDs should avoid contact with Emdocam.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Emdocam til Emdoka bvba den 18.08.2011.
The European Commission granted a marketing authorisation valid throughout the European Union, for Emdocam to Emdoka bvba on 18 August 2011.
I meget sjældne tilfælde kan der opstå anafylaktiske reaktioner, som skal behandles symptomatisk.
In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Andre oplysninger om Emdocam:
Other information about Emdocam:
Hvor lang tid skal der gå, før dyret kan slagtes, og kødet kan anvendes til menneskeligt konsum (tilbageholdelsestid)?
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Da prostaglandiner udløser betændelse, smerter, ekssudation og feber, mindsker meloxicam disse kliniske symptomer.
As the prostaglandins trigger inflammation, pain, exudation and fever, meloxicam reduces these clinical signs.
Emdocam er et lægemiddel til kvæg, grise og heste, som indeholder det aktive stof meloxicam.
Emdocam is a medicine for cattle, pigs and horses that contains the active substance meloxicam.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Emdocam.
The Committee recommended that Emdocam be given a marketing authorisation.
I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the doctor.
Hos heste kan der opstå en forbigående hævelse ved injektionsstedet, som dog forvinder uden behov for indgreb.
In horses, a transient swelling at the injection site can occur but resolves without intervention.
Emdocam indeholder meloxicam, som tilhører en gruppe lægemidler, der kaldes non-steroide antiinflammatoriske lægemidler (NSAID'er).
Emdocam contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
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.
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.
Det kan anvendes sammen med oral rehydreringsbehandling ved diarré hos kalve, der er over en uge gamle, og hos ikke-lakterende ungkvæg.
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.
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.
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.
Det fås som en klar, gul injektionsvæske, opløsning (20 mg/ml).
It is available as a clear yellow solution for injection (20 mg/ml).
Derfor mente CVMP, at ligesom det er tilfældet med Metacam, er fordelene ved Emdocam større end risiciene, når det anvendes til de godkendte indikationer.
Therefore the CVMP's view was that, as for Metacam, Emdocam's benefits are greater than its risks when used for the approved indications.
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.
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.
Meloxicam virker ved at blokere et enzym kaldet cyclooxygenase, som er med til at danne prostaglandiner.
Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
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.
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.
Hvilken risiko er der forbundet med Emdocam?
What is the risk associated with Emdocam?
Emdocam er et "generisk lægemiddel", hvilket betyder, at Emdocam svarer til et "referenceveterinærlægemiddel", som allerede er godkendt i EU (Metacam).
Emdocam is a ‘generic' medicine which means that Emdocam is similar to a ‘reference veterinary medicine' already authorised in the EU (Metacam).
Emdocam blev anset for at være bioækvivalent med referencelægemidlet.
Emdocam was considered to be bioequivalent with the reference medicine.
Hos kvæg anvendes det sammen med passende antibiotikabehandling for at reducere kliniske symptomer på akut respiratorisk infektion (infektion i lunger og luftveje) og for at behandle akut mastitis (yverbetændelse).
In cattle it is used together with appropriate antibiotics, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways) and to treat acute mastitis (inflammation of the udder).
Derfor anses fordelene ved Emdocam for at være de samme som fordelene ved referencelægemidlet.
Consequently, Emdocam's benefit is taken as being the same as that of the reference medicine.
Hvorfor blev Emdocam godkendt?
Why has Emdocam been approved?
Emdocam er "bioækvivalent" med referencelægemidlet, hvilket betyder, at det optages og udnyttes i kroppen på samme måde som Metacam.
Emdocam is ‘bioequivalent' to the reference medicine which means that it is equivalent to Metacam in the way it is absorbed and used by the body.
Hvad er Emdocam?
What is Emdocam?
Emdocam anvendes hos heste til lindring af kolik (mavesmerter) samt betændelse og smerter i forbindelse med lidelser i bevægeapparatet.
Emdocam is used in horses to relieve colic (abdominal pain) and the inflammation and pain in musculo-skeletal disorders.
Emdocam gives hos kalve som en enkelt injektion af 0,5 mg pr. kg kropsvægt under huden eller i en vene.
Emdocam is given in cattle as a single injection of 0.5 mg per kg body weight under the skin or into a vein.
Hvad anvendes Emdocam til?
What is Emdocam used for?
Det gives som en enkelt injektion i en muskel af 0,4 mg pr. kg kropsvægt.
It is given as a single injection of 0.4 mg per kg body weight into a muscle.
Emdocam gives som en enkelt injektion af 0,6 mg pr. kg kropsvægt i en af hestens vener.
Emdocam is given as a single injection of 0.6 mg per kg body weight into the horse's vein.
CVMP var af den opfattelse, at Emdocam er bioækvivalent med Metacam, i overensstemmelse med EU's krav.
The CVMP considered that, in accordance with European Union requirements, Emdocam is bioequivalent to Metacam.
Hvordan blev Emdocam undersøgt?
How has Emdocam been studied?
Hvilken fordel viser undersøgelserne, at der er ved Emdocam?
What benefit has Emdocam shown during the studies?
Hvordan virker Emdocam?
How does Emdocam work?
Det kaldes et "atypisk" antipsykotisk lægemiddel, fordi det adskiller sig fra de ældre antipsykotiske lægemidler, der har været på markedet siden 1950'erne.
It is known as an ‘atypical' antipsychotic because it is different from the older antipsychotic medicines that have been available since the 1950s.
Dosis justeres afhængigt af, hvor god patientens respons er, og hvor godt patienten tåler behandlingen.
The dose is adjusted depending on how well the patient responds to and tolerates the treatment.
Den fuldstændige EPAR for Olanzapine Cipla findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Olanzapine Cipla can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Tidligere kendt som Olanzapine Neopharma.
Previously known as Olanzapine Neopharma.