natgillin/translations-raw huggingface dataset:
Der anbringes et enkelt intraruminalt indlæg i koen eller kvien 3-4 uger før forventet kælvning ved hjælp af et passende redskab til indgivelse.
A single intraruminal device is given to a dairy cow or heifer three to four weeks before the expected calving, using an appropriate administration tool.
Hvis det er beskadiget, skal der anvendes et nyt intraruminalt indlæg.
If damaged a new intraruminal device should be used.
Ketose er en stofskifteforstyrrelse, hvor blodets indhold af glukose er lavt, og der ophober sig ketonstoffer (såsom aceteddikesyre og βhydroxysmørsyre) i blodet.
Ketosis is a metabolic disturbance in which blood glucose levels are low and substances called ketones (such as acetoacetatic acid and β-hydroxybutyrate) accumulate in the blood.
Behandlingens virkning blev hovedsagelig bedømt på stigningen i forekomsten af klinisk ketose hos køerne i løbet af en periode på 15-16 uger efter kælvning.
The main measure of effectiveness was the cumulative rate of clinical ketosis in the cows over the 15 to 16 weeks after calving.
Hvilken risiko er der forbundet med Kexxtone?
What is the risk associated with Kexxtone?
Et intraruminalt indlæg er en anordning, der indføres gennem dyrets mund og anbringes i dyrets vom eller første mave.
It is available as a continuous-release intraruminal device (a device administered through the animal's mouth and placed within the rumen, or first stomach, of cattle).
Hvorfor blev Kexxtone godkendt?
Why has Kexxtone been approved?
Hvad er Kexxtone?
What is Kexxtone?
Der skal anvendes handsker ved håndtering af produktet, herunder ved udtagelse af et opgylpet intraruminalt indlæg.
The person administering Kexxtone should wear gloves when handling the product, including when retrieving a regurgitated intraruminal device.
Efter håndtering af produktet skal handskerne aftages, og den udsatte hud vaskes.
Gloves should be removed and hands and exposed skin washed after handling the product.
Hvordan blev Kexxtone undersøgt?
How has Kexxtone been studied?
Hvad anvendes Kexxtone til?
What is Kexxtone used for?
Kontrollen af kreaturerne skal gentages i indtil fire dage efter indgivelsen med henblik på, at det intraruminale indlæg ikke er fuldstændig nedsvælget eller har sat sig fast i spiserøret.
Cattle should be re-checked for up to four days after dosing in case the intraruminal device has not been fully swallowed and has lodged in the oesophagus (the gullet or tube leading from the mouth to the rumen).
Hvilken fordel viser undersøgelserne, at der er ved Kexxtone?
What benefit has Kexxtone shown during the studies?
så der kommer flere bakterier, der producerer propionsyre, som anvendes til dannelse af glukose.
Monensin changes the population of microbes in the rumen resulting in an increase of the bacteria that produce propionate, a substance used to make glucose.
Hvordan virker Kexxtone?
How does Kexxtone work?
I henhold til EU-lovgivningen kræver sådanne handlinger, at der foretages en EU-gennemgang.
In accordance with EU legislation, this type of action required that an EU review procedure be carried out.
Mere om procedurerne
More about the procedures
Kontakt vores pressemedarbejder Monika Benstetter eller Martin Harvey
Contact our press officers Monika Benstetter or Martin Harvey
Ved den fornyede overvejelse bekræftede PRAC sit tidligere standpunkt.
For the re-examination procedure the PRAC confirmed its previous position.
Den 19. december 2013 EMA/809470/2013
19 December 2013 EMA/809470/2013
Siegemund M. Første gang fremlagt på European Society of Anaesthesiology's konference i 2012.
Siegemund M. Firstly presented at European Society of Anaesthesiology conference 2012.
Mens den fornyede overvejelse foregik, besluttede nogle medlemsstater at suspendere eller begrænse markedsføringen eller anvendelsen af disse lægemidler på deres område.
While the re-examination was ongoing, some Member States decided to suspend or limit the marketing or use of these medicines in their territories.
Litteraturhenvisninger: 1.
References: 1.
* CMDh er en lægemiddelkontrolmyndighed, der repræsenterer Den Europæiske Unions (EU's) medlemsstater.
* The CMDh is a medicines regulatory body representing the European Union (EU) Member States
Denne gennemgang fandt sted sideløbende med den fornyede overvejelse af PRAC's anbefaling fra juni 2013, og begge procedurer afsluttedes den 10. oktober 2013.
This review procedure ran in parallel with the re-examination of the PRAC's June 2013 recommendation and both procedures were finalised on 10 October 2013.
• Patienter, der har spørgsmål eller betænkeligheder, bør tale med den behandlende læge, apotekspersonalet eller en sygeplejerske.
• Patients who have any questions or concerns should speak to the treating doctor, pharmacist or nurse.
Den forventede fordel ved behandlingen bør nøje afvejes mod usikkerheden omkring den langsigtede sikkerhed, og andre behandlingsmuligheder bør overvejes.
The expected benefit of treatment should be carefully weighed against the uncertainties with regard to long-term safety, and other available treatment options should be considered.
Disse anbefalinger er baseret på en gennemgang af alle foreliggende data om sikkerhed og virkning, herunder data fra nylige kliniske undersøgelser4,5,6, metaanalyser og erfaringer efter markedsføring.
These recommendations are based on a review of all available safety and efficacy data, including recent data4,5,6, from clinical studies, meta-analyses and post-marketing experience.
Denne gennemgang, der blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC), blev afsluttet den 13. juni 2013, men nogle af indehaverne af markedsføringstilladelse anmodede om fornyet overvejelse.
This review, which had been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), concluded on 13 June 2013, but some of the marketing authorisation holders requested a re-examination.
Den 29. november 2012 indledtes en gennemgang af infusionsvæsker med hydroxyethylstivelse på anmodning af den tyske lægemiddelmyndighed i medfør af artikel 31 i direktiv 2001/83/EF.
A review of HES solutions for infusion was initiated on 29 November 2012 at the request of the German medicines agency, under Article 31 of Directive 2001/83/EC.
Den 27. juni 2013 indledte Det Forenede Kongerige derfor en EU-gennemgang af opløsninger indeholdende hydroxyethylstivelse i medfør af artikel 107, litra i), i direktiv 2001/83/EF.
Consequently, on 27 June 2013, the UK triggered an EU review of HES solutions under Article 107i of Directive 2001/83/EC.
Eftersom alle infusionsopløsninger med hydroxyethylstivelse er godkendt nationalt, blev anbefalingerne fra PRAC overgivet til koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede procedurer - human (CMDh), som vedtog sit endelige standpunkt.
As HES-containing solutions for infusion are all authorised nationally, the PRAC recommendations were forwarded to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Sundhedspersoner er blevet informeret skriftligt om resultaterne af denne gennemgang og ændringerne i brugen af opløsninger af hydroxyethylstivelse.
Healthcare professionals have been informed in writing of the outcome of the review and the changes to the use of HES solutions.
I den sideløbende artikel 107i-procedure blev der imidlertid gennemgået ny dokumentation, hvilket var grundlaget for PRAC's endelige anbefaling om anvendelsen af opløsninger af hydroxyethylstivelse.
However, new evidence was considered in the parallel Article 107i procedure and this was the basis for the PRAC's final recommendation on the use of HES solutions.
Kolloider indeholder store molekyler såsom stivelse, mens krystalloider såsom saltopløsninger eller Ringers acetat indeholder mindre molekyler.
Colloids contain large molecules such as starch, whereas crystalloids, such as saline (salt) solutions or Ringer's acetate, contain smaller molecules.
Til volumenerstatning anvendes to hovedtyper af lægemidler: krystalloider og kolloider.
There are two main types of medicines used for volume replacement: crystalloids and colloids.
• Opløsninger af hydroxyethylstivelse bør anvendes i den laveste effektive dosis i kortest mulig tid.
• HES solutions should be used at the lowest effective dose for the shortest period of time.
CMDh repræsenterer EU's medlemsstater og har ansvar for harmonisering af sikkerhedsnormerne i EU for lægemidler, der godkendes ved nationale procedurer.
The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
I EU er infusionsvæsker indeholdende hydroxyethylstivelse godkendt via nationale procedurer og markedsføres i alle medlemsstater under forskellige handelsnavne.
In the EU, HES-containing solutions for infusion have been approved via national procedures and are available in all Member States under various trade names.
For at minimere risiciene hos sådanne patienter bør opløsninger af hydroxyethylstivelse ikke anvendes i mere end 24 timer, og patienternes nyrefunktion bør overvåges efter administreringen af hydroxyethylstivelse.
In order to minimise potential risks in these patients, HES solutions should not be used for more than 24 hours and patients' kidney function should be monitored after HES administration.
Gennemgangen af opløsninger af hydroxyethylstivelse blev foretaget af PRAC efter at der var fremkommet undersøgelser, der viste øget dødelighed hos patienter med sepsis1,2 og øget risiko for dialysekrævende nyreskade hos kritisk syge patienter1,2,3 efter behandling med opløsninger af hydroxyethylstivelse.
The review of HES solutions was carried out by the PRAC following the publication of studies showing an increased risk of mortality in patients with sepsis1,2 and an increased risk of kidney injury requiring dialysis in critically ill patients1,2,3 following treatment with HES solutions.
Tilgængelig på: http://clinicaltrials.gov/ct2/show/NCT00318942
Available on: http://clinicaltrials.gov/ct2/show/NCT00318942 5.
Hydroxyethylstivelse vil være til rådighed til begrænsede patientgrupper
HES will be available in restricted patient populations
Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients:BaSES (130;0.4) Trial, opført i http://clinicaltrials.gov/show/NCT00273728
Basel Study for Evaluation of Starch (130;0.4) Infusion in Septic Patients:BaSES (130;0.4) Trial, listed at http://clinicaltrials.gov/show/NCT00273728
Eftersom CMDh vedtog sit standpunkt ved en flertalsafgørelse, blev det overgivet til EuropaKommissionen, som godkendte det og vedtog en retligt bindende afgørelse for hele EU den 19. december 2013.
As the CMDh position was adopted by majority vote, it was sent sent to the European Commission, which endorsed it and adopted an EU-wide legally binding decision on 19 December 2013.
Tilgængelig på ClinicalTrials.gov (NCT01122277), senest ajourført den 7. juli 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
Available on ClinicalTrials.gov (NCT01122277) last updated on 07 July 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
Den 23. oktober 2013 vedtog koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede procedurer - human (CMDh)* ved en flertalsafgørelse anbefalingen fra Det Europæiske Lægemiddelagenturs Udvalg for Risikovurdering inden for Lægemiddelvurdering (PRAC) om, at opløsninger af hydroxyethylcellulose ikke længere må anvendes til behandling af patienter med sepsis (bakterieinfektion i blodet) eller forbrændinger eller hos kritisk syge patienter, da dette øger dødeligheden og risikoen for nyreskade.
On 23 October 2013, the Coordination Group for Mutual Recognition and Decentralised ProceduresHuman (CMDh)*, endorsed by majority the recommendations of the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC), which concluded that HES solutions must no longer be used to treat patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients because of an increased risk of kidney injury and mortality.
Der er beskrevet øget dialysebehov op til 90 dage efter administration af hydroxyethylstivelse.
An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Behandlingen bør styres ved kontinuerlig hæmodynamisk monitorering, idet infusionen standses, så snart der er opnået tilstrækkelige hæmodynamiske resultater.
Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as appropriate haemodynamic goals have been achieved.
• Der savnes fyldestgørende langsigtede sikkerhedsdata for operationspatienter og traumepatienter.
• There is a lack of robust long-term safety data in patients undergoing surgical procedures and in patients with trauma.
Opløsninger af hydroxyethylstivelse bør seponeres ved første tegn på koagulopati.
HES solutions should be discontinued at the first sign of coagulopathy.
Produktinformationen skal opdateres, og desuden skal der foretages yderligere undersøgelser af anvendelsen af disse lægemidler ved ikke-akutte (elektive) operationer og hos traumepatienter.
In addition to updating the product information, further studies should be carried out on the use of these medicines in elective surgery and trauma patients.
Infusionsvæsker indeholdende hydroxyethylstivelse anvendes ofte som volumenerstatning og tilhører lægemiddelklassen kolloider.
Infusion solutions containing HES are frequently used for volume replacement and belong to the class known as colloids.
• Opløsninger af hydroxyethylstivelse må kun anvendes til behandling af hypovolæmi efter akut blodtab, når krystalloider alene ikke anses for at være tilstrækkelige.
• HES solutions should only be used for the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
Lægen bør imidlertid overvåge patientens nyrefunktion efter administrering af hydroxyethylstivelse.
However, the doctor should monitor the patient's kidney function after HES administration.
Der skal udføres supplerende undersøgelser med opløsninger af hydroxyethylstivelse ved traumer og elektive kirurgiske indgreb.
Additional studies will be performed with HES solutions in patients with trauma and in elective surgery.
• Opløsninger af hydroxyethylstivelse kan fortsat anvendes til behandling af lavt blodvolumen (hypovolæmi) ved pludseligt (akut) blodtab.
• HES solutions may continue to be used to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss.
Opløsninger af hydroxyethylstivelse kan fortsat anvendes til behandling af for lavt blodvolumen (hypovolæmi) ved pludseligt (akut) blodtab, når andre infusionsopløsninger (krystalloider) alene ikke anses for tilstrækkelige.
HES solutions may continue to be used in patients to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss, where treatment with alternative infusions solutions known as ‘crystalloids' alone are not considered to be sufficient.
• På grund af risiko for nyreskade og dødelighed må opløsninger af hydroxyethylstivelse ikke længere anvendes hos patienter med bakterieinfektion i blodet (sepsis) eller forbrændinger eller hos kritisk syge patienter.
• Because of the risk of kidney injury and mortality, HES solutions must no longer be used in patients with sepsis (bacterial infection in the blood) or burn injuries or critically ill patients.
• På grund af risiko for nyreskade og dødelighed må opløsninger af hydroxyethylstivelse ikke længere anvendes hos patienter med sepsis eller forbrændinger eller hos kritisk syge patienter.
• Because of the risk of kidney injury and mortality, HES solutions must no longer be used in patients with sepsis, burn injuries or critically ill patients.
Ved gentagen administration bør der foretages nøje overvågning af koagulationsparametre.
Blood coagulation parameters should be monitored carefully in case of repeated administration.
• Svær koagulopati er kontraindikation for opløsninger af hydroxyethylstivelse.
• HES solutions are contraindicated in severe coagulopathy.
Hydroxyethylstivelse skal seponeres ved første tegn på nyrebeskadigelse.
The use of HES must be discontinued at the first sign of renal injury.
• Nedsat nyrefunktion og dialysebehandling er nu kontraindikationer for hydroxyethylstivelse.
• HES solutions are now contraindicated in patients with renal impairment or renal replacement therapy.
Nyrefunktionen bør overvåges efter administration af hydroxyethylstivelse.
Patients' kidney function should be monitored after HES administration.
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Route of Administration
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Evicel den 6. oktober 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Evicel on 6 October 2008.
Den fuldstændige EPAR for Evicel findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Evicel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Evicel.
This is a summary of the European public assessment report (EPAR) for Evicel.
Andre oplysninger om Evicel
Other information about Evicel
Evicel er blevet undersøgt i to hovedundersøgelser, der omfattede i alt 282 patienter.
Evicel has been studied in two main studies involving a total of 282 patients.
Den nødvendige mængde Evicel afhænger af en række faktorer, herunder typen af det kirurgiske indgreb, sårets størrelse og antallet af applikationer.
The volume of Evicel to be used depends on a number of factors, including the type of surgery, the size of the wound and the number of applications.
Det må ikke gives som en injektion i et blodkar.
It must not be given as an injection into a blood vessel.
Evicel humant koagulabelt protein/human trombin
Evicel human clottable protein / human thrombin
Når de to aktive stoffer blandes, spalter trombin fibrinogen i mindre enheder, der kaldes fibrin.
When the two active substances are mixed together, thrombin cuts fibrinogen up into smaller units called fibrin.
Da trombinopløsningen i Evicel også anvendes i et andet lægemiddel, Quixil, anvendte virksomheden nogle af dataene fra Quixil til støtte for brugen af Evicel.
Because the thrombin solution of Evicel is also used in another medicine, Quixil, the company used some data from Quixil to support the use of Evicel.
Før brug blandes de to opløsninger af Evicel ved hjælp af en særlig anordning, der leveres sammen med lægemidlet.
Before use, the two solutions of Evicel are mixed together using a special device that is supplied with the medicine.
Det fås i form af to opløsninger: Den ene indeholder det aktive stof humant koagulabelt protein (50 til 90 mg/ml), og den anden det aktive stof human trombin (800 til 1 200 internationale enheder pr.
It is available as two solutions, one containing the active substance human clottable protein (50 to 90 mg/ml), and the other containing the active substance human thrombin (800 to 1200 international units per millilitre).
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Evicel.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Evicel.
Hvis du ønsker yderligere oplysninger om behandling med Evicel, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Evicel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
For at mindske risikoen for gasemboli ved spraypåføring vil virksomheden sørge for oplysningsmateriale og undervisning til alle de kirurger, der anvender Evicel som spray.
In order to reduce the risk of gas embolism with spray application, the company will provide educational material and training to all surgeons who will use Evicel as a spray.
Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Evicel?
What measures are being taken to ensure the safe use of Evicel?
Evicel bør kun anvendes af en erfaren kirurg, der er blevet instrueret i anvendelsen af Evicel.
Evicel should only be used by an experienced surgeon who has been trained in the use of Evicel.
I sjældne tilfælde kan patienterne også udvikle antistoffer mod proteinerne i Evicel, hvilket kan gribe ind i blodkoagulationen.
In rare cases, patients may also develop antibodies to the proteins in Evicel, which could interfere with blood clotting.
Evicel anvendes af kirurger til at hjælpe med at dæmpe lokale blødninger under operationer, hvor gængse teknikker ikke er tilstrækkelige.
Evicel is used by surgeons to help reduce local bleeding during operations when standard techniques are not sufficient.
Evicel kan som andre vævsklæbere forårsage en allergisk reaktion, der kan være svær, især hvis Evicel anvendes gentagne gange.
As for other sealants, Evicel may cause an allergic reaction which can be severe especially when Evicel is used repeatedly.
Hvilken risiko er der forbundet med Evicel?
What is the risk associated with Evicel?
Virksomheden vil desuden sikre, at Evicel anvendes sammen med trykregulatorer, hvis tryk ikke overstiger det maksimale nødvendige tryk til afgivelse af fibrinklæberen, og at regulatorerne påføres mærkater med de anbefalede værdier for tryk og afstand ved spraypåføring.
In addition, the company will ensure that Evicel is used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and that the regulators contain labels stating the recommended pressure and distance for the spray application.
Det primære effektmål var antallet af patienter, hvis lukning af dura mater var vandtæt uden væskeudskillelse.
The main measure of effectiveness was the number of patients whose dura mater closure was watertight with no leakage.
De aktive stoffer i Evicel, humant koagulabelt protein og human trombin, er naturlige stoffer, der udvindes af humant plasma (væskedelen i blodet).
The active substances in Evicel, human clottable protein and thrombin, are natural substances obtained from human plasma (the liquid part of the blood).
Det humane koagulable protein indeholder som hovedkomponent fibrinogen, dvs. et protein, der medvirker ved den naturlige størkningsproces.
The human clottable protein contains as its main component, fibrinogen, a protein involved in the natural clotting process.
CHMP besluttede, at fordelene ved Evicel opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Evicel.
The CHMP decided that Evicel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Evicel er også blevet undersøgt i en yderligere hovedundersøgelse af 139 patienter, der blev opereret i hjernen, og hvis dura mater udskilte væske efter suturering af dura-incisionen.
Evicel has also been studied in one further main study involving 139 patients undergoing brain surgery and whose dura mater was leaking fluid following suturing of the dural incision.
Evicel må ikke anvendes til patienter, der er overfølsomme (allergiske) over for humant koagulabelt protein, trombin eller andre af indholdsstofferne.
Evicel must not be used in people who are hypersensitive (allergic) to human clottable protein, thrombin or any of the other ingredients.
Evicel er et lægemiddel, der anvendes som vævsklæber (lim).
Evicel is a medicine that is used as a sealant (glue).
Fibrinet aggregerer (klæber sammen) og danner en størknet fibrinmasse, der fremmer helingen af såret og forebygger blødning.
The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, preventing bleeding.