FrancophonIA/ELRC3.0 huggingface dataset:
English: Dogs, Cattle: Single subcutaneous or intravenous injection Cats: Single subcutaneous injection Pigs: Single intramuscular injection Read the package leaflet before use
Danish: Hunde, kvæg: Enkelt subkutan injection eller intravenøs injektion Katte: Enkelt subkutan injektion
English: For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age.
Danish: Til anvendelse ved diarré i kombination med oral tilførsel af vand til at reducere symptomerne på sygdommen hos kalve, der er mere end én uge gamle.
English: Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have rarely been reported.
Danish: Typiske NSAID-bivirkninger såsom appetitløshed, opkastning, diarré, fækal okkult blødning, apati og nyresvigt er set sjældent.
English: Pigs: Can be used during pregnancy and lactation.
Danish: Grise: Kan anvendes under drægtighed og laktation.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP. Opbevaringstid efter første åbning af beholderen: 28 dage
English: THE WORDS "KEEP OUT OF SIGHT AND REACH OF CHILDREN"
Danish: TEKSTEN “OPBEVARES UTILGÆNGELIGT FOR BØRN”
English: Carton for 50 ml and 100 ml
Danish: Karton til 50 ml og 100 ml
English: Cats: SC
Danish: s.c
English: Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Danish: Må ikke indgives sammen med glucocortikosteroider, andre ikke-steroide antiinflammatoriske lægemidler eller koagulationshæmmende midler.
English: Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Danish: Må ikke anvendes til dyr, som lider af nedsat lever-, hjerte- eller nyrefunktion og hæmoragiske lidelser, eller i tilfælde, hvor der er tegn på ulcerogene gastrointestinale læsioner.
English: To obtain pain relief during surgery co-medication with an appropriate anaesthetic/sedative is needed.
Danish: Til smertelindring ved operationer kræves komedicinering med et passende anæstetikum/sedativ.
English: Dogs: IV or SC
Danish: i.v eller s.c
English: For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders.
Danish: Til anvendelse ved lindring af inflammation og smerter ved såvel akutte som kroniske lidelser i bevægeapparatet.
English: Carton for the 10 ml, 20 ml and 100 ml
Danish: Karton til 10 ml, 20 ml og 100 ml
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 µg/ml and 2.7 µg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
Danish: Efter en enkelt subkutan dosis på 0,5 mg meloxicam/kg opnåedes Cmax værdier på 2,1 g/ml efter 7,7 timer og 2,7 g/ml efter 4 timer hos henholdsvis ungkvæg og lakterende køer.
English: 3421 TV Oudewater The Netherlands tel: fax: e-mail:
Danish: Le Vet Beheer B.V.Wilgenweg 7 3421 TV Oudewater Nederlandene tlf: fax: e-mail:
English: Active substance: Meloxicam 20 mg
Danish: Aktivt stof: Meloxicam 20 mg
English: Cattle: Meat and offal: 15 days Pigs:
Danish: Kvæg: Kød og indmad: 15 dage Grise:
English: Active substance: Meloxicam 5 mg
Danish: Aktivt stof: Meloxicam 5 mg
English: Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there may be a potential risk of renal toxicity.
Danish: Undgå behandling af dehydrerede, hypovolæmiske eller hypotensive dyr, idet der foreligger en potentiel risiko for toksisk påvirkning af nyrerne.
English: In very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been reported.
Danish: I meget sjældne tilfælde er der set hæmoragisk diarré, opkastning af blod samt mavesår.
English: EXP (month/year) Once broached, use by….
Danish: EXP (måned/år) Efter anbrud, anvendes inden ….
English: Following single intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.1 to 1.5 μg/ml was reached within 1 hour in pigs.
Danish: Efter en enkelt intramuskulær dosis på 0,4 mg meloxicam/kg nåedes en Cmax-værdi på 1,1 til 1,5 μg/ml efter 1 time i grise.
English: Disodium edetate Sodium hydroxide Hydrochloric acid Meglumine Water for injections
Danish: Dinatriumedetat Natriumhydroxid Saltsyre
English: After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 µg/ml was reached after 1 hour in pigs.
Danish: Efter to intramuskulære doser på 0,4 mg meloxicam/kg opnåedes efter 1 time en Cmax værdi på 1,9 g/ml hos grise.
English: After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml were reached after 7.7 hours in young cattle.
Danish: Efter en enkelt subkutan dosis på 0,5 mg meloxicam/kg nåedes en Cmax-værdi på 2,1 μg/ml efter 7,7 timer i ungkvæg.
English: In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
Danish: I meget sjældne tilfælde kan anafylaktiske reaktioner forekomme.
English: Meloxidolor 20 mg/ml solution for injection for cattle, pigs and horses meloxicam
Danish: Meloxidolor 20 mg/ml injektionsvæske, opløsning til kvæg, grise og heste meloxicam
English: Meloxidolor 5 mg/ml solution for injection for dogs, cats, cattle and pigs meloxicam
Danish: Meloxidolor 5 mg/ml injektionsvæske, opløsning til hunde, katte, kvæg og grise meloxicam
English: Horses: Do not use in pregnant or lactating mares.
Danish: Må ikke anvendes til drægtige eller lakterende hopper.
English: Meloxidolor 5 mg/ml solution for injection for dogs, cats, cattle and pigs
Danish: Meloxidolor 5 mg/ml injektionsvæske, opløsning til hunde, katte, kvæg og grise
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.
Danish: En enkelt intramuskulær injektion af en dosis på 0,4 mg meloxicam/kg kropsvægt (dvs. 0,4 ml/5 kg kropsvægt) før operation.
English: Meloxidolor 20 mg/ml solution for injection for cattle, pigs and horses
Danish: Meloxidolor 20 mg/ml injektionsvæske, opløsning til kvæg, grise og heste
English: Marker residue
Danish: Restmarkør Dyreart
English: Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).
Danish: En enkelt subkutan injektion af en dosis på 0,2 mg meloxicam/kg kropsvægt (dvs. 0,4 ml/10 kg kropsvægt).
English: Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.
Danish: En enkelt subkutan injektion af en dosis på 0,3 mg meloxicam/kg kropsvægt (dvs. 0,06 ml/kg kropsvægt) før operation, for eksempel ved indledning af anæstesi.
English: Cattle: meat and offal: 15 days; milk: 5 days Pigs:
Danish: kød og indmad: 15 dage; mælk: 5 dage
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/25 kg body weight).
Danish: En enkelt intramuskulær injektion af en dosis på 0,4 mg meloxicam/kg kropsvægt (dvs. 2 ml/25 kg kropsvægt).
English: Locomotor disorders:
Danish: Lidelser i bevægeapparatet:
English: Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate.
Danish: Enkelt intramuskulær injektion på 0,4 mg meloxicam/kg legemsvægt (d.v.s. 2 ml/100 kg legemsvægt) i kombination med passende antibiotika-behandling.
English: EXP {month/year} Once broached, use by ….
Danish: EXP {måned/år} Efter anbrud, anvendes inden ….
English: meat and offal: 5 days
Danish: Kød og indmad: 5 dage
English: Meat and offal: 5 days
Danish: kød og indmad: 5 dage
English: Pigs:
Danish: Grise:
English: Sodium hydroxide Hydrochloric acid Glycofurol Meglumine Water for injections
Danish: Natriumhydroxid Saltsyre
English: Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Danish: En enkelt subkutan eller intravenøs injektion af en dosis på 0,5 mg meloxicam/kg kropsvægt (dvs. 10 ml/100 kg kropsvægt) kombineret med antibiotisk behandling eller med oral rehydreringsbehandling i nødvendigt omfang.
English: Colourless type I glass vials of 10 ml, 20 ml or 100 ml, closed with a rubber stopper and sealed with an aluminium cap.
Danish: Farveløse hætteglas af type I, 10 ml, 20 ml eller 100 ml, lukket med gummiprop og forseglet med aluminiumshætte.
English: Colourless type I glass vial containing 50 ml or 100 ml, closed with a rubber stopper and sealed with an aluminium cap.
Danish: Farveløse hætteglas af type I, der hver indeholder 50 ml eller 100 ml, lukket med gummiprop og forseglet med en aluminiumshætte.
English: Single intravenous injection at a dosage of 0.6 mg meloxicam/kg body weight (i.e. 3 ml/100 kg body weight).
Danish: Heste: Enkelt intravenøs injektion på 0,6 mg meloxicam/kg legemsvægt (d.v.s. 3 ml/100 kg legemsvægt).
English: Cattle: Meat and offal: 15 days Pigs: Meat and offal: 5 days
Danish: Kvæg: kød og indmad: 15 dage; mælk: 5 dage Grise: kød og indmad: 5 dage Heste: kød og indmad: 5 dage.
English: Do not use in cattle and pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.
Danish: Må ikke anvendes til kvæg eller grise med nedsat lever-, hjerte- eller nyrefunktion eller med blødningsforstyrrelser eller til dyr, der viser tegn på sårfremkaldende forandringer i mave-tarmsystemet.
English: Horses: meat and offal: 5 days.
Danish: Kød og indmad: 5 dage.
English: Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Danish: Enkelt subkutan eller intravenøs injektion på 0,5 mg meloxicam/kg legemsvægt (d.v.s. 2,5 ml/100 kg legemsvægt), om nødvendigt i kombination med antibiotika-behandling eller med oral tilførsel af passende mængder vand.
English: For the relief of pain associated with equine colic.
Danish: Til anvendelse ved lindring af smerte i forbindelse med kolik hos hest.
English: Colourless type I glass vials of 50 ml or 100 ml, closed with a rubber stopper and sealed with an aluminium cap.
Danish: Farveløse hætteglas af type I, 50 ml eller 100 ml, lukket med gummiprop og aluminiumkapsel.
English: Equidae
Danish: Meglumin
English: The European Commission issued a decision on 2 October 2009.
Danish: Europa-Kommissionen traf en afgørelse den 2. oktober 2009.
English: Dr. Hudson (United Kingdom)
Danish: Dr. Hudson (Det Forenede Kongerige)
English: Dr. Broich (Germany)
Danish: Dr. Broich (Tyskland)
English: The amended information to healthcare professionals and patients is available here.
Danish: De ændrede informationer til sundhedspersonale og patienter findes her.
English: 23 October 2008
Danish: 23. oktober 2008
English: The company wanted the authorisation to be recognised in France and Portugal (the ‘concerned Member States').
Danish: Virksomheden ønskede, at markedsføringstilladelsen skulle anerkendes i Frankrig og Portugal ("de berørte medlemsstater").
English: 25 June 2009
Danish: 25. juni 2009
English: Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Danish: Artikel 29 i direktiv 2001/83/EF, med senere ændringer, indbringelse på grund af potentiel alvorlig risiko for folkesundheden.
English: London, 2 October 2009 Doc.
Danish: London, den 2. oktober 2009 Dok.
English: It works by blocking enzymes that bacteria use to make more DNA.
Danish: Det virker ved at blokere de enzymer, som bakterier bruger til at producere mere DNA.
English: Complicated means that the infection is difficult to treat because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Danish: "Kompliceret" betyder, at infektionen er vanskelig at behandle, fordi den har bredt sig til det dybe væv under huden, fordi operativ behandling kan være nødvendig, eller fordi patienten har andre tilstande, der kan påvirke responsen på behandlingen.
English: The grounds for the referral were concerns from France regarding the medicine's risk of causing problems with the heart rhythm (QT-interval prolongation).
Danish: Begrundelserne for indbringelsen var Frankrigs betænkeligheder med hensyn til lægemidlets risiko for at medføre problemer med hjerterytmen (QT-intervalforlængelse).
English: However, the Member States were not able to reach an agreement and the German medicines regulatory agency referred the matter to the CHMP for arbitration on 10 October 2008.
Danish: Medlemsstaterne kunne imidlertid ikke nå til enighed, og den tyske lægemiddelkontrolmyndighed indbragte den 10. oktober 2008 sagen for CHMP med henblik på voldgift.
English: By doing this, it stops the bacteria from growing and multiplying.
Danish: På denne måde hindrer det bakterierne i at vokse og formere sig.
English: Questions and answers on the referral for Octegra solution for infusion containing moxifloxacin 400 mg/250 ml
Danish: Spørgsmål og svar vedrørende indbringelsesproceduren for Octegra infusionsvæske, opløsning, indeholdende moxifloxacin 400 mg/250 ml
English: The review was carried out under an ‘Article 29' referral1.
Danish: Revurderingen fandt sted inden for rammerne af en indbringelsesprocedure i henhold til artikel 291.
English: Bayer Vital GmbH submitted Octegra solution for infusion for mutual recognition on the basis of the initial authorisation granted by Germany on 30 April 2002.
Danish: Bayer Vital GmbH ansøgte om gensidig anerkendelse for Octegra infusionsvæske, opløsning, på baggrund af den første markedsføringstilladelse, der blev udstedt af Tyskland den 30. april 2002.
English: The CHMP also recommended that the product information for the medicine should be amended in all the Member States where it is authorised.
Danish: CHMP anbefalede ligeledes, at produktinformationen for lægemidlet blev ændret i alle
English: It can be used to treat the following bacterial infections: - community-acquired pneumonia (an infection of the lungs that is caught outside of hospital); - complicated infections of the skin and the soft tissues below the skin.
Danish: Det kan anvendes til behandling af følgende bakterieinfektioner: - samfundserhvervet pneumoni (en lungeinfektion, som man smittes med uden for hospitalerne), - komplicerede hud- og bløddelsinfektioner.
English: The active substance in Octegra solution for infusion, moxifloxacin, belongs to the group ‘fluoroquinolones'.
Danish: Det aktive stof i Octegra infusionsvæske, opløsning, moxifloxacin, hører til gruppen af "fluorquinoloner".
English: Company responses provided on: 26 January 2009; 27 April 2009; 28 May 2009 Opinion date:
Danish: 26. januar 2009; 27. april 2009; 28. maj 2009
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Octegra solution for infusion.
Danish: Det Europæiske Lægemiddelagentur (EMEA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for lægemidlet Octegra infusionsvæske, opløsning.
English: Octegra solution for infusion is an antibiotic given by infusion (drip into a vein).
Danish: Octegra infusionsvæske, opløsning, er et antibiotikum, der gives som infusion (drop i en vene).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Octegra solution for infusion outweigh its risks, and the marketing authorisation granted in Germany can be recognised in other Member States of the EU, namely France and Portugal.
Danish: EMEA's Udvalg for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Octegra infusionsvæske, opløsning, opvejer risiciene, og at den markedsføringstilladelse, der er udstedt i Tyskland, kan anerkendes i andre EU-medlemsstater, nemlig Frankrig og Portugal.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Octegra solution for infusion outweigh its risks, and therefore the marketing authorisation for Octegra solution for infusion should be granted in all concerned Member States.
Danish: På grundlag af vurderingen af de tilgængelige data og den faglige drøftelse i udvalget konkluderede CHMP, at fordelene ved Octegra infusionsvæske, opløsning, opvejer risiciene, og at der derfor bør udstedes markedsføringstilladelse for Octegra infusionsvæske, opløsning, i alle de berørte medlemsstater.
English: Why was Octegra solution for infusion reviewed?
Danish: Hvorfor blev Octegra infusionsvæske, opløsning, vurderet igen?
English: However, the prescribing information for Octegra solution for infusion should be amended in all the Member States where it is authorised.
Danish: Ordinationsoplysningerne for Octegra infusionsvæske, opløsning, skal dog ændres i alle de medlemsstater, hvor lægemidlet har markedsføringstilladelse.
English: What is Octegra solution for infusion?
Danish: Hvad er Octegra infusionsvæske, opløsning?
English: The Committee recommended that:
Danish: Udvalget anbefalede:
English: 20 February 2013
Danish: Den 20. februar 2013
English: It was authorised in October 2008 and is available in 11 EU member states1.
Danish: Den blev godkendt i oktober 2008 og er til rådighed i 11 lande i EU 1.
English: 1 Austria, Denmark, Estonia, France, Finland, Germany, Ireland, Netherlands, Spain, Sweden and United Kingdom, as well as Norway.
Danish: 1 Østrig, Danmark, Estland, Frankrig, Finland, Tyskland, Irland, Nederlandene, Spanien, Sverige og Det Forenede Kongerige samt Norge.
English: Outcome of procedures under Article 20 of Regulation (EC) No 726/2004 and Article 31 of Directive 2001/83/EC
Danish: Resultatet af procedurerne i henhold til artikel 20 i forordning (EF) nr. 726/2004 og artikel 31 i direktiv 2001/83/EF
English: This indicates that the risk minimisation measures have not been sufficient.
Danish: Dette viser, at risikominimeringsforanstaltningerne ikke har været tilstrækkelige.
English: The European Commission issued a decision for Evicel on 13 February 2013 and for Quixil on 20 February 2013.
Danish: Europa-Kommissionen traf en afgørelse for Evicel den 13. februar 2013 og for Quixil den 20. februar
English: Evicel is the only centrally authorised fibrin sealant.
Danish: Evicel er den eneste centralt godkendte fibrinklæber.
English: When the two solutions are mixed together, thrombin breaks fibrinogen up into smaller units called fibrin.
Danish: Når de to opløsninger blandes sammen, nedbryder trombin fibrinogen til mindre enheder, der hedder fibrin.
English: The full changes made to the product information for Evicel are detailed here, and for Quixil here.
Danish: Samtlige ændringer af produktinformationen for Evicel er angivet her, og for Quixil her.
English: Consequently, in May 2012, the European Commission asked the CHMP to issue an opinion on whether further measures are necessary to ensure the safe use of Evicel and on whether its marketing authorisation should be maintained, varied, suspended or withdrawn across the EU.
Danish: Europa-Kommissionen anmodede derfor i maj 2012 CHMP om at fremsætte en udtalelse om, hvorvidt det er nødvendigt med yderligere foranstaltninger for at garantere sikker anvendelse af Evicel og om, hvorvidt markedsføringstilladelsen for dette lægemiddel bør opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: At the same time, the UK's medicines regulatory agency requested the CHMP to carry out the same assessment for Quixil and the other fibrin sealants available in the EU.
Danish: Samtidig anmodede Det Forenede Kongeriges lægemiddelstyrelse CHMP om at foretage samme vurdering af Quixil og de øvrige fibrinklæbere, der er på markedet i EU.
English: The solution is currently sprayed using either pressurised air or carbon dioxide (CO2).
Danish: Til påføring som spray anvendes på nuværende tidspunkt enten trykluft eller kuldioxid (CO2).
English: They are composed of two solutions, one containing fibrinogen and the other containing thrombin, which are both proteins involved in the blood clotting process.
Danish: De består af to opløsninger, hvoraf den ene indeholder fibrinogen, og den anden indeholder trombin, som begge er proteiner, der medvirker ved blodets størkning.
English: However, since then, three further cases of gas embolism have been reported with Evicel, which were due to insufficient distance between the applicator and tissue or too high spray pressure.
Danish: Siden da er der imidlertid indberettet yderligere tre tilfælde af gasemboli med Evicel som følge af utilstrækkelig afstand mellem applikatoren og vævet eller for højt spraytryk.
English: The Committee also agreed that the company marketing these medicines should provide a letter to relevant healthcare professionals in the EU explaining these risk minimisation measures.
Danish: Udvalget vedtog desuden, at den virksomhed, der markedsfører disse lægemidler, skal udsende et brev til de pågældende sundhedspersoner i EU, hvor disse risikominimeringsforanstaltninger forklares.
English: The CHMP also noted that, although cases of gas embolism are rare, there is a need to take further measures to prevent this life-threatening risk.
Danish: CHMP bemærkede desuden, at skønt gasemboli er sjælden, må der træffes yderligere foranstaltninger for at undgå denne livstruende risiko.
English: • the wording for the product information should be strengthened and educational materials updated to provide clear and consistent information to surgeons on the recommended pressure and distance during spray application;
Danish: • at ordlyden af produktoplysningerne skærpes og oplysningsmaterialet opdateres, så der giver klar og sammenhængende information til kirurgerne om det tryk og den afstand, der anbefales ved spraypåføring,
English: In addition, care should be taken during laparoscopy (another type of less invasive surgical procedure) to ensure that the minimum safe distance from the tissues is observed;
Danish: Desuden skal der udvises forsigtighed under laparoskopi (en anden mindre invasiv ope rationsteknik) for at garantere, at den sikre mindsteafstand til vævene overholdes,
English: • these medicines should not be sprayed in endoscopic surgery (a type of less invasive surgical procedure).
Danish: • at disse lægemidler ikke spraypåføres ved endoskopiske operationer (en mindre invasiv operati onsteknik).
English: • Evicel and Quixil should be sprayed using CO2 only, instead of pressurised air, because the greater solubility of CO2 in blood reduces the risk of embolism;
Danish: • at Evicel og Quixil udelukkende spraypåføres ved hjælp af CO2 i stedet for trykluft, fordi den større opløselighed af CO2 i blodets mindsker risikoen for emboli,
English: On 15 November 2012, the European Medicines Agency completed a review of the safety and effectiveness of the fibrin sealants Evicel and Quixil given by spray application, following cases of gas embolisms reported with these medicines.
Danish: Den 15. november 2012 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af sikkerheden og virkningen af fibrinklæberne Evicel og Quixil, givet som spray, efter at der var indberettet tilfælde af gasemboli med disse lægemidler.
English: In August 2010, measures were taken to minimise the risk of gas embolism (presence of a gas bubble in the blood that affects the blood flow) following five reported cases involving Evicel or Quixil applied
Danish: I august 2010 blev der truffet foranstaltninger til mindskelse af risikoen for gasemboli (gasbobler i blodet, som påvirker blodgennemstrømningen), efter at der var indberettet om fem tilfælde med Evicel eller Quixil efter påføring som spray.