FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Consequently, on 27 June 2013, the UK triggered an EU review of HES solutions under Article 107i of Directive 2001/83/EC.
Danish: 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.
English: 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.
Danish: 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.
English: Healthcare professionals have been informed in writing of the outcome of the review and the changes to the use of HES solutions.
Danish: Sundhedspersoner er blevet informeret skriftligt om resultaterne af denne gennemgang og ændringerne i brugen af opløsninger af hydroxyethylstivelse.
English: 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.
Danish: 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.
English: Colloids contain large molecules such as starch, whereas crystalloids, such as saline (salt) solutions or Ringer's acetate, contain smaller molecules.
Danish: Kolloider indeholder store molekyler såsom stivelse, mens krystalloider såsom saltopløsninger eller Ringers acetat indeholder mindre molekyler.
English: There are two main types of medicines used for volume replacement: crystalloids and colloids.
Danish: Til volumenerstatning anvendes to hovedtyper af lægemidler: krystalloider og kolloider.
English: • HES solutions should be used at the lowest effective dose for the shortest period of time.
Danish: • Opløsninger af hydroxyethylstivelse bør anvendes i den laveste effektive dosis i kortest mulig tid.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Danish: CMDh repræsenterer EU's medlemsstater og har ansvar for harmonisering af sikkerhedsnormerne i EU for lægemidler, der godkendes ved nationale procedurer.
English: 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.
Danish: I EU er infusionsvæsker indeholdende hydroxyethylstivelse godkendt via nationale procedurer og markedsføres i alle medlemsstater under forskellige handelsnavne.
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Available on: http://clinicaltrials.gov/ct2/show/NCT00318942 5.
Danish: Tilgængelig på: http://clinicaltrials.gov/ct2/show/NCT00318942
English: HES will be available in restricted patient populations
Danish: Hydroxyethylstivelse vil være til rådighed til begrænsede patientgrupper
English: 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
Danish: 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
English: 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.
Danish: 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.
English: Available on ClinicalTrials.gov (NCT01122277) last updated on 07 July 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
Danish: Tilgængelig på ClinicalTrials.gov (NCT01122277), senest ajourført den 7. juli 2011: http://clinicaltrials.gov/ct2/show/NCT01122277?term=NCT01122277&rank=1
English: 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.
Danish: 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.
English: An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Danish: Der er beskrevet øget dialysebehov op til 90 dage efter administration af hydroxyethylstivelse.
English: Treatment should be guided by continuous haemodynamic monitoring so that the infusion is stopped as soon as appropriate haemodynamic goals have been achieved.
Danish: Behandlingen bør styres ved kontinuerlig hæmodynamisk monitorering, idet infusionen standses, så snart der er opnået tilstrækkelige hæmodynamiske resultater.
English: • There is a lack of robust long-term safety data in patients undergoing surgical procedures and in patients with trauma.
Danish: • Der savnes fyldestgørende langsigtede sikkerhedsdata for operationspatienter og traumepatienter.
English: HES solutions should be discontinued at the first sign of coagulopathy.
Danish: Opløsninger af hydroxyethylstivelse bør seponeres ved første tegn på koagulopati.
English: 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.
Danish: Produktinformationen skal opdateres, og desuden skal der foretages yderligere undersøgelser af anvendelsen af disse lægemidler ved ikke-akutte (elektive) operationer og hos traumepatienter.
English: Infusion solutions containing HES are frequently used for volume replacement and belong to the class known as colloids.
Danish: Infusionsvæsker indeholdende hydroxyethylstivelse anvendes ofte som volumenerstatning og tilhører lægemiddelklassen kolloider.
English: • HES solutions should only be used for the treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient.
Danish: • Opløsninger af hydroxyethylstivelse må kun anvendes til behandling af hypovolæmi efter akut blodtab, når krystalloider alene ikke anses for at være tilstrækkelige.
English: However, the doctor should monitor the patient's kidney function after HES administration.
Danish: Lægen bør imidlertid overvåge patientens nyrefunktion efter administrering af hydroxyethylstivelse.
English: Additional studies will be performed with HES solutions in patients with trauma and in elective surgery.
Danish: Der skal udføres supplerende undersøgelser med opløsninger af hydroxyethylstivelse ved traumer og elektive kirurgiske indgreb.
English: • HES solutions may continue to be used to treat hypovolaemia (low blood volume) caused by acute (sudden) blood loss.
Danish: • Opløsninger af hydroxyethylstivelse kan fortsat anvendes til behandling af lavt blodvolumen (hypovolæmi) ved pludseligt (akut) blodtab.
English: 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.
Danish: 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.
English: • 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.
Danish: • 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.
English: • 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.
Danish: • 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.
English: Blood coagulation parameters should be monitored carefully in case of repeated administration.
Danish: Ved gentagen administration bør der foretages nøje overvågning af koagulationsparametre.
English: • HES solutions are contraindicated in severe coagulopathy.
Danish: • Svær koagulopati er kontraindikation for opløsninger af hydroxyethylstivelse.
English: The use of HES must be discontinued at the first sign of renal injury.
Danish: Hydroxyethylstivelse skal seponeres ved første tegn på nyrebeskadigelse.
English: • HES solutions are now contraindicated in patients with renal impairment or renal replacement therapy.
Danish: • Nedsat nyrefunktion og dialysebehandling er nu kontraindikationer for hydroxyethylstivelse.
English: Patients' kidney function should be monitored after HES administration.
Danish: Nyrefunktionen bør overvåges efter administration af hydroxyethylstivelse.
English: Oral use sachet , , , , , , , , , , (Paper/LDPE/alu/ n n n LDPE)
Danish: Brev (papir/LDPE/alu/LDPE)
English: Gastro-resistant v granules
Danish: Enterogranulat
English: sachets
Danish: 30 breve
English: Route of Administration
Danish: Oral anvendelse
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evicel on 6 October 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Evicel den 6. oktober 2008.
English: The full EPAR for Evicel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Evicel findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Evicel.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Evicel.
English: Other information about Evicel
Danish: Andre oplysninger om Evicel
English: Evicel has been studied in two main studies involving a total of 282 patients.
Danish: Evicel er blevet undersøgt i to hovedundersøgelser, der omfattede i alt 282 patienter.
English: 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.
Danish: Den nødvendige mængde Evicel afhænger af en række faktorer, herunder typen af det kirurgiske indgreb, sårets størrelse og antallet af applikationer.
English: It must not be given as an injection into a blood vessel.
Danish: Det må ikke gives som en injektion i et blodkar.
English: Evicel human clottable protein / human thrombin
Danish: Evicel humant koagulabelt protein/human trombin
English: When the two active substances are mixed together, thrombin cuts fibrinogen up into smaller units called fibrin.
Danish: Når de to aktive stoffer blandes, spalter trombin fibrinogen i mindre enheder, der kaldes fibrin.
English: 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.
Danish: Da trombinopløsningen i Evicel også anvendes i et andet lægemiddel, Quixil, anvendte virksomheden nogle af dataene fra Quixil til støtte for brugen af Evicel.
English: Before use, the two solutions of Evicel are mixed together using a special device that is supplied with the medicine.
Danish: Før brug blandes de to opløsninger af Evicel ved hjælp af en særlig anordning, der leveres sammen med lægemidlet.
English: 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).
Danish: 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.
English: 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.
Danish: 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.
English: For more information about treatment with Evicel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: 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.
English: 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.
Danish: For at mindske risikoen for gasemboli ved spraypåføring vil virksomheden sørge for oplysningsmateriale og undervisning til alle de kirurger, der anvender Evicel som spray.
English: What measures are being taken to ensure the safe use of Evicel?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri anvendelse af Evicel?
English: Evicel should only be used by an experienced surgeon who has been trained in the use of Evicel.
Danish: Evicel bør kun anvendes af en erfaren kirurg, der er blevet instrueret i anvendelsen af Evicel.
English: In rare cases, patients may also develop antibodies to the proteins in Evicel, which could interfere with blood clotting.
Danish: I sjældne tilfælde kan patienterne også udvikle antistoffer mod proteinerne i Evicel, hvilket kan gribe ind i blodkoagulationen.
English: Evicel is used by surgeons to help reduce local bleeding during operations when standard techniques are not sufficient.
Danish: Evicel anvendes af kirurger til at hjælpe med at dæmpe lokale blødninger under operationer, hvor gængse teknikker ikke er tilstrækkelige.
English: As for other sealants, Evicel may cause an allergic reaction which can be severe especially when Evicel is used repeatedly.
Danish: Evicel kan som andre vævsklæbere forårsage en allergisk reaktion, der kan være svær, især hvis Evicel anvendes gentagne gange.
English: What is the risk associated with Evicel?
Danish: Hvilken risiko er der forbundet med Evicel?
English: 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.
Danish: 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.
English: The main measure of effectiveness was the number of patients whose dura mater closure was watertight with no leakage.
Danish: Det primære effektmål var antallet af patienter, hvis lukning af dura mater var vandtæt uden væskeudskillelse.
English: The active substances in Evicel, human clottable protein and thrombin, are natural substances obtained from human plasma (the liquid part of the blood).
Danish: De aktive stoffer i Evicel, humant koagulabelt protein og human trombin, er naturlige stoffer, der udvindes af humant plasma (væskedelen i blodet).
English: The human clottable protein contains as its main component, fibrinogen, a protein involved in the natural clotting process.
Danish: Det humane koagulable protein indeholder som hovedkomponent fibrinogen, dvs. et protein, der medvirker ved den naturlige størkningsproces.
English: The CHMP decided that Evicel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Evicel opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Evicel.
English: 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.
Danish: 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.
English: Evicel must not be used in people who are hypersensitive (allergic) to human clottable protein, thrombin or any of the other ingredients.
Danish: Evicel må ikke anvendes til patienter, der er overfølsomme (allergiske) over for humant koagulabelt protein, trombin eller andre af indholdsstofferne.
English: Evicel is a medicine that is used as a sealant (glue).
Danish: Evicel er et lægemiddel, der anvendes som vævsklæber (lim).
English: The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, preventing bleeding.
Danish: Fibrinet aggregerer (klæber sammen) og danner en størknet fibrinmasse, der fremmer helingen af såret og forebygger blødning.
English: Why has Evicel been approved?
Danish: Hvorfor blev Evicel godkendt?
English: In dura mater closure, 92% of patients treated with Evicel (82 out of 89) had a watertight closure compared with 38% of the patients who did not receive Evicel (19 out of 50).
Danish: Ved lukning af dura mater havde 92 % af de patienter, der blev behandlet med Evicel (82 ud af 89), en vandtæt lukning sammenlignet med 38 % af de patienter, der ikke fik Evicel (19 ud af 50).
English: What is Evicel?
Danish: Hvad er Evicel?
English: Cases of gas embolism (gas bubbles in the blood that affect the blood flow) have occurred when Evicel was applied as spray.
Danish: Der er indberettet tilfælde af gasemboli (gasbobler i blodet, som påvirker blodgennemstrømningen) med Evicel givet som spray.
English: The study compared the effectiveness of Evicel in addition to sutures with sutures alone in sealing the dura mater.
Danish: I undersøgelsen blev virkningen af Evicel som støttebehandling til suturer sammenlignet med suturer alene til forsegling af dura mater.
English: During abdominal surgery, 95% of the patients had no bleeding 10 minutes after treatment with Evicel (63 out of 66), compared with 81% of the patients treated with Surgicel (56 out of 69).
Danish: Ved abdominalkirurgi havde 95 % af patienterne ingen blødninger ti minutter efter behandling med Evicel (63 ud af 66) sammenlignet med 81 % af de patienter, der blev behandlet med Surgicel (56 ud af 69).
English: Thromboembolic complications (blood clots) may occur if Evicel is unintentionally injected into a blood vessel.
Danish: Tromboemboliske komplikationer (blodpropper) kan optræde, hvis Evicel utilsigtet gives som injektion i et blodkar.
English: The main measure of effectiveness was the number of patients with no bleeding at the site of application, 10 minutes after having received Evicel or Surgicel.
Danish: Det primære mål for virkningen var antallet af patienter uden blødninger på applikationsstedet ti minutter efter, at der var blevet anvendt Evicel eller Surgicel.
English: For the full list of all side effects reported with Evicel, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Evicel fremgår af indlægssedlen.
English: The first study compared Evicel with manual compression (applying direct pressure) in reducing bleeding during vascular surgery.
Danish: I den første undersøgelse blev Evicel sammenlignet med manuel kompression (anvendelse af direkte tryk) til dæmpning af blødning under karkirurgi.
English: Evicel can also be used in addition to sutures to obtain a watertight closure of the dura mater (a thin fluid-filled membrane surrounding the brain and the spinal cord) during brain surgery.
Danish: Evicel kan desuden anvendes som støttebehandling i forbindelse med suturer for at opnå en vandtæt lukning af dura mater (en tynd væskefyldt membran, der omgiver hjernen og rygraden) under operationer i hjernen.
English: The second study compared Evicel with Surgicel (a material used to help control bleeding) in reducing bleeding during abdominal surgery (surgery of organs in the tummy).
Danish: I den anden undersøgelse blev Evicel sammenlignet med Surgicel (et materiale, der anvendes til at kontrollere blødning) til dæmpning af blødning under abdominalkirurgi (kirurgisk indgreb i organerne i maven).
English: What is Evicel used for?
Danish: Hvad anvendes Evicel til?
English: The main measure of effectiveness was the number of patients with no bleeding (haemostasis) at the site of application, four minutes after having received Evicel or manual compression.
Danish: Det primære mål for virkningen var antallet af patienter uden blødninger (hæmostase) på applikationsstedet fire minutter efter, at der var blevet anvendt Evicel eller manuel kompression.