FrancophonIA/ELRC3.0 huggingface dataset:
English: This summary was last updated in 03-2016.
Danish: Dette sammendrag blev sidst ajourført i 03-2016.
English: The European Commission granted a marketing authorisation valid throughout the European Union for TachoSil on 8 June 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for TachoSil den 8. juni 2004.
English: EPAR summary for the public
Danish: EPAR - sammendrag til offentligheden
English: The full EPAR for TachoSil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for TachoSil 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 TachoSil.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for TachoSil.
English: TachoSil fibrinogen / thrombin
Danish: TachoSil fibrinogen/trombin
English: Other information about TachoSil
Danish: Andre oplysninger om TachoSil
English: A risk management plan has been developed to ensure that TachoSil is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at TachoSil anvendes så sikkert som muligt.
English: The TachoSil patch is left in the body, where it dissolves and disappears completely.
Danish: TachoSil-plastret efterlades i kroppen, hvor det opløses og forsvinder fuldstændigt.
English: TachoSil should only be applied directly onto the treatment site so that it covers 1 to 2 cm beyond the edge of the wound.
Danish: Tachosil bør kun appliceres direkte på behandlingsstedet, så det dækker 1-2 cm uden for sårranden.
English: Like other sealants, TachoSil may cause an allergic reaction.
Danish: Ligesom andre vævsklæbere kan TachoSil medføre en allergisk reaktion.
English: What measures are being taken to ensure the safe and effective use of TachoSil?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af TachoSil?
English: For more information about treatment with TachoSil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med TachoSil, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Effectiveness was measured by looking at whether air leaked from the lungs after surgery.
Danish: Effektiviteten blev målt ved at se på, om der slap luft ud fra lungerne efter operationen.
English: TachoSil should only be used by an experienced surgeon.
Danish: TachoSil bør kun anvendes af erfarne kirurger.
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 TachoSil.
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, hvordan TachoSil skal anvendes.
English: TachoSil is used when standard techniques are not sufficient.
Danish: TachoSil anvendes, når almindelige teknikker ikke slår til.
English: The main measure of effectiveness was the number of patients whose bleeding had stopped after three minutes.
Danish: Som mål for virkningen anvendtes først og fremmest det antal patienter, hvor blødningen var ophørt efter tre minutter.
English: The CHMP decided that TachoSil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved TachoSil opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for TachoSil.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for TachoSil, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for TachoSil, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: • Two studies were carried out to see if TachoSil could be used as a tissue sealant.
Danish: • To forsøg blev gennemført for at se, om TachoSil kunne bruges som vævsklæber.
English: The first study looking at lung surgery patients was not sufficient to support the use of TachoSil in sealing tissue since very few patients in the study had any air leakage.
Danish: Det første forsøg med patienter, der gennemgik en lungeoperation, var ikke tilstrækkeligt til at understøtte brugen af TachoSil til at forsegle væv, idet kun ganske få patienter i forsøget havde en luftutæthed.
English: TachoSil is a sealant patch coated with the active substances human fibrinogen and human thrombin.
Danish: TachoSil er et vævsplaster, der er belagt med de aktive stoffer human fibrinogen og human trombin.
English: • during neurological surgery to prevent leakage of the fluid surrounding the brain (called cerebrospinal fluid or CSF).
Danish: • ved neurologisk kirurgi for at undgå lækage fra den væske, der omgiver hjernen (kaldet cerebrospinalvæske eller CSF)
English: In the first study, the average time until bleeding stopped was 3.9 minutes with TachoSil compared with 6.3 minutes with the argon beamer, and in the second study, these values were 3.6 and 5.0 minutes, respectively.
Danish: I det første forsøg var den gennemsnitlige tid, indtil blødningen standsede, 3,9 minutter med TachoSil, sammenholdt med 6,3 minutter med argonbeaming, og i det andet forsøg var disse værdier hhv. 3,6 og 5,0 minutter.
English: After three minutes, bleeding had stopped in 75% of the patients treated with TachoSil (44 out of 59), compared with 33% of those treated with standard techniques (20 out of 60).
Danish: Efter tre minutter var blødningen standset i 75 % af de patienter, der blev behandlet med TachoSil (44 ud af 59), sammenlignet med 33 % af de, der blev behandlet med de sædvanlige teknikker (20 ud af 60).
English: • Another study in 726 patients compared TachoSil with current techniques used in daily practice in preventing CSF leakage during neurological surgery.
Danish: • En anden undersøgelse, hvori der deltog 726 patienter, sammenlignedes TachoSil med de sædvanlige teknikker, der anvendes i daglig praksis til forhindring af CSF-lækage under neurologisk kirurgi.
English: However, in the second study, which involved 301 patients, it took an average of 15.3 hours for leakage to stop with TachoSil compared with 20.5 hours with current techniques.
Danish: Men i det andet forsøg, der omfattede 301 patienter, tog det i gennemsnit 15,3 timer at stoppe lækagen med TachoSil sammenlignet med 20,5 timer med de sædvanlige teknikker.
English: • Two of the studies looked at the effects of TachoSil in stopping bleeding.
Danish: • I to af forsøgene undersøgtes virkningerne af TachoSil til at standse blødning.
English: What is the risk associated with TachoSil?
Danish: Hvilken risiko er der forbundet med TachoSil?
English: The active substances in TachoSil, fibrinogen and thrombin, are proteins extracted from blood, which are involved in the natural clotting process.
Danish: De aktive stoffer i TachoSil, fibrinogen og trombin, er proteiner, der er udvundet af blod og medvirker ved blodets naturlige størkning.
English: In neurological surgery, it works by sealing together the cut areas of the outermost layer (dura mater) of the membranes around the brain.
Danish: Ved neurologisk kirurgi virker det ved at forsegle de opskårne områder i de yderste lag af membranerne omkring hjernen (dura mater).
English: TachoSil is used in adults:
Danish: TachoSil anvendes til voksne
English: TachoSil has been studied in seven studies:
Danish: TachoSil er blevet undersøgt i syv forsøg.
English: Patients may also develop antibodies to the proteins in TachoSil, which could interfere with blood clotting.
Danish: I sjældne tilfælde kan patienter også udvikle antistoffer over for de proteiner, der findes i TachoSil, hvilket kunne gribe ind i blodets størkningsproces.
English: • during an operation, to stop bleeding and to seal the surfaces of internal organs;
Danish: • under kirurgiske indgreb til at stoppe blødninger og til at forsegle vævsoverflader på indre organer
English: • A sixth study looked at the effectiveness of TachoSil in surgery on the heart or major blood vessels.
Danish: • Et sjette forsøg så på TachoSils effektivitet ved operationer i hjertet eller i de store blodkar.
English: This way it prevents the cerebrospinal fluid from leaking.
Danish: På denne måde undgås lækage fra cerebrospinalvæsken.
English: For the full list of all side effects and restrictions with TachoSil, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved TachoSil fremgår af indlægssedlen.
English: The amount of TachoSil to be used depends on the size of the wound and the material can be cut to size if needed.
Danish: Størrelsen på sårområdet bestemmer det nødvendige mængde TachoSil, og materialet kan i givet fald klippes til.
English: Thrombin works by converting fibrinogen into smaller units called fibrin, which then stick together to form a local clot.
Danish: Trombin virker ved at spalte fibrinogen til mindre enheder, der kaldes fibrin, som derefter hæfter sammen og danner en lokal størknet blodmasse.
English: When TachoSil is applied to a bleeding area during surgery, the moisture causes the active substances to react together, leading to the rapid formation of a clot.
Danish: Når TachoSil appliceres på det blødende område under operationen, bevirker fugten, at de aktive stoffer reagerer med hinanden, så blodet hurtigt størkner.
English: Why has TachoSil been approved?
Danish: Hvorfor blev TachoSil godkendt?
English: The main measure of effectiveness was the time until the bleeding stopped.
Danish: Behandlingens virkning blev hovedsagelig bedømt på den tid, der gik, indtil blødningen ophørte.
English: TachoSil was also more effective than standard materials at stopping bleeding during surgery on the heart or blood vessels.
Danish: TachoSil var også mere effektiv end de sædvanlige materialer til at standse blødninger under en operation i hjertet eller i blodkarrene.
English: In the study in neurological surgery, TachoSil was comparable to current techniques: around 7% (25 out of 361) of patients treated with TachoSil had a leak of CSF, compared with around 8% (30 out of 365) of patients on current techniques.
Danish: I undersøgelsen af neurologisk kirurgi blev TachoSil sammenlignet med de sædvanlige teknikker: ca. 7 % (25 ud af 361) af de patienter, der blev behandlet med TachoSil, havde en CSF-lækage, sammenlignet med 8 % (30 ud af 365) af de patienter, der blev behandlet med de sædvanlige teknikker.
English: The studies compared the effects of TachoSil and an argon beamer (a device that sears the cut surface and reduces bleeding) in a total of 240 adults having liver surgery.
Danish: I disse forsøg blev virkningerne af TachoSil sammenlignet med virkningerne af en argonbeamer (et apparat, som kauteriserer det sårede område og mindsker blødningen) hos i alt 240 patienter, der gennemgik en leveroperation.
English: The clot enables the patch to stick more firmly to the tissue, helping to stop the bleeding and sealing the wound.
Danish: Den størknede blodmasse holder plastret fast mod vævet, så blødning undgås, og såret forsegles.
English: TachoSil was more effective than the argon beamer at stopping bleeding during liver surgery.
Danish: TachoSil var mere effektiv end argonbeaming til at standse blødningen under leveroperationer.
English: The study compared TachoSil with standard materials in 120 patients, of whom around three-quarters also had surgery on vessels with stitches and one-quarter had surgery on the heart.
Danish: I forsøget blev TachoSil sammenlignet med gængse materialer i 120 patienter, hvoraf ca. tre fjerdedele gennemgik karkirurgiske operationer med sutur, og én fjerdedel gennemgik hjertekirurgiske operationer.
English: What is TachoSil?
Danish: Hvad er TachoSil?
English: A third study compared TachoSil with standard stitching in 185 patients having kidney surgery.
Danish: I et tredje forsøg blev TachoSil sammenlignet med almindelig sutur hos 185 patienter, der gennemgik en nyreoperation.
English: The studies compared TachoSil and standard surgical techniques, such as stitching and stapling, in a total of 490 patients having lung surgery.
Danish: I forsøgene blev TachoSil sammenlignet med sædvanlige operationsteknikker som sutur og hæftning hos i alt 490 patienter, der gennemgik en lungeoperation.
English: How has TachoSil been studied?
Danish: Hvordan blev TachoSil undersøgt?
English: TachoSil was more effective than stitching in the kidney surgery patients.
Danish: TachoSil var mere effektiv end sutur hos patienter, der gennemgik en nyreoperation.
English: What is TachoSil used for?
Danish: Hvad anvendes TachoSil til?
English: What benefit has TachoSil shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved TachoSil?
English: TachoSil must not be applied inside a blood vessel.
Danish: TachoSil må ikke anvendes intravaskulært.
English: • as support to stitching during surgery on the blood vessels;
Danish: • som en støtte i forbindelse med suturer ved karkirurgi
English: How is TachoSil used?
Danish: Hvordan anvendes TachoSil?
English: Thromboembolic complications (blood clots in vessels) may occur if TachoSil is applied inside a blood vessel.
Danish: Hvis TachoSil utilsigtet føres ind i en vene, kan det medføre tromboemboliske komplikationer (blodpropper).
English: How does TachoSil work?
Danish: Hvordan virker TachoSil?
English: This summary was last updated in 04-2008.
Danish: Dette sammendrag blev sidst ajourført i 04-2008.
English: It should be used according to official recommendations.
Danish: Den skal anvendes i overensstemmelse med de officielle anbefalinger.
English: • killed whole B. pertussis;
Danish: • dræbte, hele B. pertussis,
English: The Hib component has also been available in other vaccines.
Danish: Hibkomponenten har også været tilgængelig i andre vacciner.
English: These active substances were also available in other vaccines before that date.
Danish: Disse aktive stoffer var også tilgængelige i andre vacciner før 1996.
English: This means that the active substances are fixed on aluminium compounds, to stimulate a better immune response.
Danish: Det vil sige, at de aktive stoffer er bundet til aluminiumsforbindelser for at fremkalde et bedre immunrespons.
English: The vaccine is ‘adsorbed'.
Danish: Vaccinen er adsorberet.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om baggrunden for CHMP's anbefalinger, kan du læse den faglige drøftelse (også en del af denne EPAR).
English: The European Commission granted a marketing authorisation valid throughout the EU for Quintanrix to GlaxoSmithKline Biologicals s.a. on 21 October 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Quintanrix til GlaxoSmithKline Biologicals s.a. den 21. oktober 2004.
English: Quintanrix contains small amounts of:
Danish: Quintanrix indeholder små mængder af:
English: In all of the studies, the main measure of effectiveness was the production of protective levels of antibodies after the final vaccination.
Danish: I alle undersøgelserne var det primære mål for virkning udviklingen af beskyttende niveauer af antistoffer efter den sidste vaccination.
English: Quintanrix is a vaccine.
Danish: Quintanrix er en vaccine.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) QUINTANRIX EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) QUINTANRIX EPAR - sammendrag for offentligheden
English: It should not be given if the child has had encephalopathy (a brain disease) of unknown cause within seven days of a previous vaccination with a vaccine containing pertussis.
Danish: Den bør ikke gives, hvis barnet har haft hjernelidelsen encefalopati af ukendte årsager inden for syv dage efter en tidligere vaccination med en vaccine, der indeholder kighostebakterie.
English: The vaccine is given by deep injection into a muscle, preferably the thigh.
Danish: Vaccinen gives som en dyb injektion i en muskel, fortrinsvis i låret.
English: The Committee recommended that Quintanrix be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Quintanrix.
English: The effects of Quintanrix have been studied in five main studies involving over 2,000 infants.
Danish: Virkningerne af Quintanrix blev undersøgt i fem hovedundersøgelser, hvor mere end 2 000 spædbørn deltog.
English: The full EPAR for Quintanrix can be found here.
Danish: Den fuldstændige EPAR for Quintanrix findes her.
English: It is also used as a booster immunisation of young children during the second year of life.
Danish: Den anvendes også som booster-immunisering (revaccination) af små børn i deres andet leveår.
English: There was no impact of prior hepatitis B vaccination on the effectiveness of Quintanrix.
Danish: En tidligere hepatitis B-vaccination påvirkede ikke virkningen af Quintanrix.
English: Quintarix was as effective as the two separate vaccines at producing protective levels of antibodies.
Danish: Quintanrix var lige så effektiv som de to særskilte vacciner med hensyn til udvikling af beskyttende antistofniveauer.
English: Quintanrix is a vaccine, which is available as a powder and suspension to be made up into a suspension for injection.
Danish: Quintanrix er en vaccine, der fås som et pulver og suspension, som blandes til en suspension til injektion.
English: Quintanrix should not be used in people who may be hypersensitive (allergic) to any of the active substances or any of the other ingredients.
Danish: Quintanrix bør ikke anvendes til personer, der kan være overfølsomme over for et eller flere af de aktive stoffer eller et eller flere af de andre indholdsstoffer.
English: The most common side effects with Quintanrix (seen in more than 1 in 10 doses of the vaccine) are irritability, drowsiness, loss of appetite, pain, redness and swelling, and fever.
Danish: De hyppigste bivirkninger ved Quintanrix (som ses ved mere end 1 ud af 10 doser vaccine) er irritabilitet, døsighed, appetitløshed, smerte, rødme og hævelse samt feber.
English: Other information about Quintanrix:
Danish: Andre oplysninger om Quintanrix:
English: Quintanrix can be given to children who received a hepatitis B vaccine at birth.
Danish: Quintanrix kan gives til børn, der fik en hepatitis B-vaccine, da de blev født.
English: The first dose can be administered at six weeks of age.
Danish: Den første dosis kan gives, når barnet er seks uger gammelt.
English: Quintanrix should be postponed in people with a severe sudden fever.
Danish: Vaccination med Quintanrix skal udskydes hos personer med pludseligt opstået, alvorlig feber.
English: The recommended vaccination schedule for Quintanrix is three doses, given at intervals of at least four weeks within the first six months of life.
Danish: Det anbefalede vaccinationsprogram for Quintanrix består af tre doser, der gives med mindst fire ugers mellemrum i løbet af barnets seks første levemåneder.
English: • ‘surface antigen' (proteins from the surface) of the hepatitis B virus.
Danish: • overfladeantigen, dvs. proteiner fra overfladen, fra hepatitis B-virussen.
English: The study of booster vaccination also showed Quintanrix was as effective as the two separate vaccines, with between 92 and 100% of the infants having protective levels of antibodies 42 days after the booster vaccination.
Danish: Undersøgelsen af booster-vaccinationen viste, at Quintanrix var lige så effektiv som de to særskilte vacciner, idet mellem 92 og 100 % af spædbørnene havde beskyttende antistofniveauer 42 dage efter booster-vaccinationen.
English: • toxoids from the bacteria that cause diphtheria and tetanus;
Danish: • toksoider fra den bakterie, der fremkalder difteri og stivkrampe,
English: It contains the following active substances: toxoids (chemically weakened toxins) from diphtheria and tetanus, inactivated (killed) Bordetella pertussis (a bacterium that causes whooping cough), parts of the hepatitis B virus and polysaccharides (sugars) from the bacterium Haemophilus influenzae type b (‘Hib', a bacterium that causes meningitis).
Danish: Den indeholder følgende aktive stoffer: difteri- og stivkrampetoksoider (kemisk svækkede toksiner), inaktiverede (dræbte) Bordetella pertussis (kighostebakterie), dele af hepatitis B-virus og polysakkarider (sukkere) fra bakterien Haemophilus influenzae type b (‘Hib', en bakterie, der fremkalder meningitis).
English: After the first vaccination course, a booster should be given, preferably before the end of the second year of life.
Danish: Der bør gives en boosterdosis efter det første vaccinationsprogram, helst inden barnet fylder to år.
English: The active substances in Quintanrix have been available in the European Union (EU) for a number of years in other vaccines: diphtheria, tetanus, pertussis and hepatitis B, has been available in Tritanrix HepB since 1996.
Danish: De aktive stoffer i Quintanrix har været på markedet i Den Europæiske Union (EU) i en årrække i andre vacciner, f.eks. difteri, stivkrampe, kighoste og hepatitis B, der har været tilgængelige i Tritanrix HepB siden 1996.
English: Overall, between 95 and 100% of the infants had protective levels of antibodies to diphtheria, tetanus, pertussis, hepatitis B and Hib, one month after the first vaccination course.
Danish: Samlet set havde mellem 95 og 100 % af spædbørnene beskyttende antistofniveauer mod difteri, stivkrampe, kighoste, hepatitis B og Hib en måned efter det første vaccinationsprogram.
English: Quintanrix can also be used to boost previous vaccinations against diphtheria, tetanus and pertussis, against hepatitis B or against Hib, when it should be given at least six months after the last dose of the first vaccination course.
Danish: Quintanrix kan også anvendes til at forstærke tidligere vaccinationer mod difteri, stivkrampe og kighoste, mod hepatitis B eller mod Hib, når den gives mindst seks måneder efter det første vaccinationsprograms sidste dosis.
English: For the full list of side effects reported with Quintanrix, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Quintanrix fremgår af indlægssedlen.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Quintanrix's benefits are greater than its risks for primary immunisation of infants (during the first year of life) against diphtheria, tetanus, pertussis, hepatitis B and invasive disease caused by Hib and for booster immunisation of young children during the second year of life.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Quintanrix er større end risiciene ved Quintanrix ved primær immunisering af spædbørn i løbet af deres første leveår mod difteri, stivkrampe, kighoste, hepatitis B og invasive sygdomme fremkaldt af Hib og som booster immunisering af små børn i løbet af deres andet leveår.
English: What is the risk associated with Quintanrix?
Danish: Hvilken risiko er der forbundet med Quintanrix?
English: The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Danish: De fremstilles af en gærart, der har modtaget et gen (DNA), som gør den i stand til at producere proteinerne.
English: Why has Quintanrix been approved?
Danish: Hvorfor blev Quintanrix godkendt?
English: The fifth study looked at the effects of a fourth, booster dose of Quintanrix in the second year of life in 357 infants.
Danish: I den femte undersøgelse, hvor 357 spædbørn deltog, blev virkningen af en fjerde boosterdosis Quintanrix undersøgt, når den blev givet i børnenes andet leveår.