FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that animals are treated in the early stages of respiratory disease and that their response is evaluated within 48 hours.
Danish: Det anbefales at behandle dyrene i den tidlige fase af luftvejssygdomsforløbet og vurdere virkningen inden for 48 timer efter injektionen.
English: Draxxin must not be used in animals that are producing milk for human consumption, or in pregnant animals intended to produce milk for human consumption within two months of their expected date of giving birth.
Danish: Draxxin må ikke anvendes til dyr, der producerer mælk til menneskeligt konsum, eller til drægtige dyr, der er beregnet til at producere mælk til menneskeligt konsum, senere end to måneder før forventet fødsel.
English: This has not been seen in pigs and sheep after intramuscular injection.
Danish: Dette er ikke observeret hos svin eller får efter intramuskulær injektion.
English: Two weeks after treatment 84% of Draxxin-treated sheep were successfully treated compared to 82% of tilmicosin-treated sheep.
Danish: To uger efter behandlingen var 84 % de får, der blev behandlet med Draxxin, kureret, sammenlignet med 82 % af de får, der blev behandlet med tilmicosin.
English: What is Draxxin and what is it used for?
Danish: Hvad er Draxxin, og hvad anvendes det til?
English: Antibiotic resistance is the ability of bacteria to grow in the presence of an antibiotic that would normally kill them or limit their growth.
Danish: Antibiotikaresistens er en tilstand, hvor bakterier kan vokse, selv når der er et antibiotikum til stede, der ellers ville dræbe dem eller begrænse deres vækst.
English: However, the third study found no difference between the effectiveness of Draxxin, oxytetracycline and placebo.
Danish: I den tredje undersøgelse blev der imidlertid ikke fundet nogen forskel mellem effekten af Draxxin, oxytetracyclin og placebo.
English: If Draxxin accidentally gets into the eyes, they should be flushed immediately with clean water.
Danish: Hvis Draxxin utilsigtet kommer i kontakt med øjnene, skal øjnene straks skylles i rent vand.
English: The most common side effects with Draxxin in sheep (which may affect more than 1 in 10 sheep) are short lived signs of discomfort (head shaking, rubbing the injection site and backing away) lasting only a few minutes.
Danish: De hyppigste bivirkningen ved Draxxin hos får (som kan optræde hos mere end 1 ud af 10 dyr) er kortlivede tegn på ubehag (hvor dyret ryster hovedet, gnubber injektionsstedet eller bakker væk), som kun varer få minutter.
English: Draxxin is used to treat the following diseases if they are caused by bacteria that are sensitive to tulathromycin:
Danish: Draxxin anvendes til behandling af følgende sygdomme, hvis de er forårsaget af bakterier, der er følsomme over for tulathromycin:
English: However, some bacteria can develop resistance against tulathromycin, which will reduce its effectiveness.
Danish: Nogle bakterier kan dog udvikle resistens over for tulathromycin, hvilket vil reducere Draxxins effekt.
English: In all studies, Draxxin was at least as effective as the comparator medicines.
Danish: I alle undersøgelserne var Draxxin mindst lige så effektivt som de lægemidler, det blev sammenlignet med.
English: In case of accidental selfinjection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Danish: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: If accidental skin exposure occurs, the skin should be washed immediately with soap and water.
Danish: I tilfælde af utilsigtet kontakt med huden skal huden straks vaskes med vand og sæbe.
English: Temporary pain and swelling at the injection site in cattle can last up to 30 days after subcutaneous injection.
Danish: Midlertidig smerte og hævelse på injektionsstedet hos kvæg kan vare i op til 30 dage efter injektion under huden.
English: Draxxin can also be used for metaphylaxis of BRD and SRD.
Danish: Draxxin kan endvidere anvendes til metafylakse af BRD og SRD.
English: Draxxin is available as a solution for injection (25 mg/ml and 100 mg/ml).
Danish: Draxxin fås som en injektionsvæske, opløsning (25 mg/ml og 100 mg/ml).
English: A single 2.5 mg/kg dose of Draxxin was effective in treating and preventing further outbreak of BRD in cattle and SRD in pigs.
Danish: En enkelt dosis på 2,5 mg/kg Draxxin var effektiv til at behandle og forebygge BRD hos kvæg og SRD hos svin.
English: • infectious bovine keratoconjunctivitis (IBK) in cattle, an eye disease caused by Moraxella bovis;
Danish: • infektiøs Bovin Keratokonjunktivitis (IBK) hos kvæg, en øjensygdom der er forårsaget af Moraxella bovis
English: The 25 mg/ml solution for injection is for pigs only whilst the 100 mg/ml solution for injection is for cattle, pigs and sheep.
Danish: Opløsningen til injektionsvæske 25 mg/ml er kun til grise, mens opløsningen til injektionsvæske 100 mg/ml er til kvæg, grise og får.
English: Other information about Draxxin:
Danish: Andre oplysninger om Draxxin
English: What are the risks associated with Draxxin?
Danish: Hvilke risici er der forbundet med Draxxin?
English: Draxxin should not be used in animals that are hypersensitive (allergic) to macrolide antibiotics.
Danish: Draxxin bør ikke anvendes til dyr, der er overfølsomme (allergiske) over for makrolidantibiotika.
English: In two studies, it was compared with placebo, and the third study also compared it with oxytetracycline (another antibiotic).
Danish: I to af undersøgelserne blev det sammenlignet med placebo, og i den tredje undersøgelse blev det endvidere sammenlignet med oxytetracyclin (et andet antibiotikum).
English: Draxxin is effective against the bacteria that most commonly cause BRD, SRD, IBK and foot rot.
Danish: Draxxin er effektivt imod de bakterier, der hyppigst forårsager BRD, SRD, IBK og klovspalteforrådnelse.
English: Draxxin was as effective as tilmicosin in treating the early stages of severe foot rot.
Danish: Draxxin var lige så effektivt som tilmicosin til behandling af de tidligere stadier af svær klovspalteforrådnelse.
English: Draxxin was compared with tilmicosin or florfenicol (other antibiotics), and, in the prevention studies also with placebo (a dummy treatment).
Danish: Draxxin blev sammenlignet med tilmicosin eller florfenicol (andre antibiotika) og i forebyggelsesundersøgelserne endvidere med placebo (en uvirksom behandling).
English: For effectiveness in treating foot rot in sheep, Draxxin was compared to tilmicosin in a study involving 477 sheep with typical signs of foot rot (foul smell, damaged tissue between the claws of at least one foot and lameness).
Danish: Med hensyn til effektiviteten af Draxxin til behandling af klovspalteforrådnelse hos får blev Draxxin sammenlignet med tilmicosin i en undersøgelse omfattende 477 får med de typiske tegn på klovspalteforrådnelse (dårlig lugt, beskadiget væv mellem tæerne på mindst en fod og halten).
English: In pigs it is injected into a muscle, and the dose is divided in pigs weighing over 80 kg so that no more than 2 ml are injected at one site.
Danish: Hos svin gives injektionen ind i en muskel, og hos svin, der vejer over 80 kg, deles dosis således, at der ikke injiceres mere end 2 ml på samme sted.
English: The active substance in Draxxin, tulathromycin, is an antibiotic that belongs to the class ‘macrolides'.
Danish: Det aktive stof i Draxxin, tulathromycin, er et antibiotikum, der tilhører gruppen af "makrolider".
English: Draxxin is an antibiotic medicine that contains the active substance tulathromycin.
Danish: Draxxin et antibiotisk lægemiddel, der indeholder det aktive stof tulathromycin.
English: In two of the three studies of IBK, Draxxin was more effective than placebo in curing the disease.
Danish: I to af de tre IBKundersøgelser var Draxxin mere effektivt end placebo til at kurere sygdommen.
English: • bovine respiratory disease (BRD) in cattle caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis;
Danish: • luftvejsinfektioner hos kvæg (BRD), der er forårsaget af Mannheimia haemolytica, Pasteurella multocida, Histophilus somni og Mycoplasma bovis
English: The effectiveness of Draxxin in treating SRD has been studied in pigs in two main studies, where it was compared with the antibiotics tiamulin or florfenicol.
Danish: Effekten af Draxxin til behandling af SRD er blevet afprøvet i to hovedundersøgelser med svin, hvor det blev sammenlignet med de antibiotiske lægemidler tiamulin eller florfenicol.
English: The effectiveness of Draxxin in treating or preventing BRD was studied in nine main studies involving calves, carried out during an outbreak of the disease.
Danish: Virkningen af Draxxin til behandling eller forebyggelse af BRD er blevet afprøvet i ni hovedundersøgelser med kalve, hvor undersøgelserne blev gennemført under et udbrud af sygdommen.
English: How does Draxxin work?
Danish: Hvordan virker Draxxin?
English: Treatment with Draxxin was compared to another antibiotic, tildipirosin.
Danish: Behandling med Draxxin blev sammenlignet med tildipirosin, som er et andet antibiotikum.
English: For the metaphylaxis of SRD, the effectiveness of Draxxin was studied in six main studies, in which it was compared with placebo.
Danish: Til metafylakse af SRD blev Draxxins effektivitet afprøvet i seks hovedundersøgelser, hvori det blev sammenlignet med placebo.
English: What benefits of Draxxin have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Draxxin?
English: In cattle, it is injected under the skin, and the dose is divided in cattle weighing over 300 kg so that no more than 7.5 ml are injected at one site.
Danish: Til behandling af kvæg, der vejer over 300 kg, skal dosis deles således, at der ikke injiceres mere end 7,5 ml på samme sted.
English: For the treatment of IBK, the effectiveness of Draxxin has been studied in three main studies involving calves.
Danish: Til behandling af IBK er virkningen af Draxxin blevet afprøvet i tre hovedundersøgelser med kalve.
English: For more information about treatment with Draxxin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Draxxin, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Draxxin, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Draxxin, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: In sheep, Draxxin is injected into the neck muscle.
Danish: Hos får gives Draxxin som injektion i nakkemusklen.
English: SRD with Bordetella bronchiseptica present.
Danish: En tredje undersøgelse omfattede svin med SRD og Bordetella bronchiseptica.
English: Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica.
Danish: • luftvejsinfektioner hos svin (SRD), der er forårsaget af Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis og Bordetella bronchiseptica.
English: Looking at the studies taken together, it was more effective than placebo.
Danish: Når alle undersøgelserne blev vurderet under ét, var Draxxin mere effektivt end placebo.
English: These include the following:
Danish: Disse foranstaltninger er følgende:
English: 15 March 2013
Danish: Den 15. marts 2013
English: The European Commission issued a decision on 15 March 2013.
Danish: Europa-Kommissionen traf en afgørelse den 15. marts 2013.
English: The full changes made to the information to doctors and patients are detailed here.
Danish: Alle ændringer af oplysningerne til læger og patienter er gengivet i deres helhed her.
English: What are the recommendations for surgeons?
Danish: Hvilke anbefalinger gives der til kirurger?
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 kaldes fibrin.
English: Due to the close similarity of Evicel and Quixil, the CHMP concluded its review of Evicel and Quixil in November 20121.
Danish: På grund af den store lighed mellem Evicel og Quixil afsluttede CHMP sin gennemgang af Evicel og Quixil i november 20121.
English: Several fibrin sealants have been authorised in European Union (EU) Member States through national procedures.
Danish: I EU-medlemsstaterne er flere fibrinklæbere godkendt ved nationale procedurer.
English: Why were fibrin sealants reviewed?
Danish: Hvorfor blev fibrinklæbere vurderet igen?
English: 1 For information on the outcome of this review, see: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Fibrinogencontaining_solutions_for_sealant_authorised_for_administration_by_spray_application/human_referral_000329.jsp&mid=W C0b01ac05805c516f
Danish: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Fibrinogencontaining_solutions_for_sealant_authorised_for_administration_by_spray_application/human_referral_000329.jsp&mid=WC0b0 1ac05805c516f
English: They are composed of two solutions, one containing fibrinogen and another containing thrombin, both of which are 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: What are fibrin sealants?
Danish: Hvad er fibrinklæbere?
English: Evicel is the only centrally authorised fibrin sealant for use by spray application.
Danish: Evicel er den eneste centralt godkendte fibrinklæber til påføring som spray.
English: The Committee also agreed that the company marketing Tisseel, Tissucol and Artiss should provide a letter to relevant healthcare professionals in the EU including important information on the safe use of these medicines.
Danish: Udvalget vedtog desuden, at den virksomhed, der markedsfører Tisseel, Tissucol og Artiss, skal udsende et brev til de pågældende sundhedspersoner i EU med vigtige oplysninger om sikker anvendelse af disse lægemidler.
English: Beriplast P does not require a gas-assisted spray device.
Danish: Til Beriplast P behøves ingen gasassisteret sprayanordning.
English: • the wording of 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: • 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 spray påføring,
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines continue to outweigh their risks, but that appropriate measures have to be put in place to optimise the safe use of these medicines when they are applied as a spray during surgery.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved disse lægemidler fortsat er større end risiciene, men at der bør træffes passende foranstaltninger for at garantere sikker anvendelse af dem, når de påføres som spray under en operation.
English: Fibrin sealants are medicines that are used as a sealant (glue) during surgery to help reduce local bleeding.
Danish: Fibrinklæbere er lægemidler, der anvendes som vævsklæber (lim) under operationer for at mindske blødningen lokalt.
English: Fibrin sealants can be applied by dripping or spraying the solution onto bleeding tissue.
Danish: Fibrinklæbere kan påføres ved at dryppe eller spraye opløsningen på det blødende væv.
English: A group of experts in blood products, haemostasis (the stopping of bleeding) and surgery was also consulted.
Danish: Udvalget rådførte sig derudover med en gruppe af eksperter i blodprodukter, hæmostase (standsning af blødning) og kirurgi.
English: • There is no risk of gas embolism with Beriplast P when used in accordance with the prescribing advice and with the recommended device.
Danish: • Der er ingen risiko for gasemboli med Beriplast P, når det anvendes i overensstemmelse med produktoplysningerne og med den anbefalede anordning.
English: At the same time, the United Kingdom medicines agency requested a similar assessment for Quixil and for the other fibrin sealants authorised in EU countries, given that the risk of air embolism could not be excluded for these products.
Danish: se om en tilsvarende vurdering for Quixil og for de øvrige fibrinklæbere, der er godkendt i EU-lande, da det ikke kan udelukkes, at der er risiko for luftemboli med disse produkter.
English: In particular, when spraying these products: the recommended pressures should not be exceeded, and the sealant should not be sprayed at a closer distance than recommended; patients should be closely monitored for signs of possible gas embolism (by measuring blood pressure, pulse rate, and oxygen and CO2 levels in the blood).
Danish: Specielt gælder følgende ved spraypåføring af disse produkter: de anbefalede trykværdier må ikke overskrides, og fibrinklæberen må ikke sprayes i kortere afstand end anbefalet, patienterne skal overvåges tæt for eventuelle tegn på gasemboli (ved måling af blodtryk, puls og blodets ilt- og CO2-indhold).
English: • Surgeons should note the potential risk of gas embolism with incorrect spray application of Tisseel, Tissucol and Artiss and take the necessary precautions detailed in the updated prescribing advice for these medicines.
Danish: • Kirurgerne skal være opmærksomme på den potentielle risiko for gasemboli ved ukorrekt spraypåføring af Tisseel, Tissucol og Artiss og træffe de nødvendige forholdsregler som beskrevet i de opdaterede produktoplysninger for disse lægemidler.
English: The Committee also considered the spray devices used together with these medicines, and the benefit of giving fibrin sealants by spray application.
Danish: Udvalget gennemgik desuden de sprayanordninger, der anvendes med disse lægemidler, og fordelene ved at anvende fibrinklæbere ved spraypåføring.
English: • the product information should include a warning that the risk of gas embolism appears to be higher when fibrin sealants are sprayed using air, as compared to CO2, and patients should be closely monitored for signs of possible gas embolism.
Danish: • produktinformationen skal indeholde en advarsel om, at risikoen for gasemboli synes at være stør re, når fibrinklæbere spraypåføres med trykluft end med CO2, og patienterne bør overvåges tæt for evt. tegn på gasemboli.
English: The CHMP noted that all of the cases of gas embolism seen with Evicel and Quixil were related to the use of the spray device at higher-than-recommended pressures or in closer proximity to the tissue surface than recommended.
Danish: CHMP konstaterede, at i alle de iagttagne tilfælde af gasemboli med Evicel og Quixil var sprayanordningen blevet anvendt med et højere tryk end det anbefalede eller med tættere afstand til vævsoverfladen end anbefalet.
English: On 13 December 2012, the European Medicines Agency completed a review of the safety and effectiveness of the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names), following concerns over the risk of gas embolism when these medicines are given by spray application.
Danish: Den 13. december 2012 afsluttede Det Europæiske Lægemiddelagentur en gennemgang af sikkerheden og virkningen af fibrinklæberne Tisseel, Tissucol, Artiss og Beriplast P (og relaterede navne) efter betænkeligheder ved risikoen for gasemboli med disse lægemidler, når de gives som spray.
English: The CHMP reviewed the available safety data on fibrin sealants from clinical studies, post-marketing use and the published literature, focusing on reported cases of confirmed or suspected gas embolism.
Danish: CHMP gennemgik de foreliggende sikkerhedsdata om fibrinklæbere fra kliniske undersøgelser, fra anvendelse efter markedsføring og fra den videnskabelige litteratur med særligt henblik på tilfælde af bekræftet eller formodet gasemboli.
English: As Beriplast P (and associated names) does not require a gas-assisted spray device, the CHMP concluded that there is no risk of gas embolism with this product when used in accordance with the prescribing advice and with the recommended device.
Danish: Da Beriplast P (og relaterede navne) ikke kræver gasassisteret sprayanordning, konkluderede CHMP, at der ikke er risiko for gasemboli med dette produkt, når det anvendes i henhold til produktoplysningerne og med den anbefalede anordning.
English: For Evicel, Quixil, Tisseel, Tissucol and Artiss, the solution is currently sprayed using either pressurised air or carbon dioxide (CO2).
Danish: Til spraypåføring af Evicel, Quixil, Tisseel, Tissucol og Artiss anvendes på nuværende tidspunkt enten trykluft eller kuldioxid (CO2).
English: Regarding Tisseel, Tissucol and Artiss (and associated names), the CHMP concluded that, although the risk of gas embolism was considered very low, risk minimisation measures should be implemented when these medicines are given by spray application to help ensure they are used safely.
Danish: Vedrørende Tisseel, Tissucol og Artiss (og relaterede navne) konkluderede CHMP, at skønt risikoen for gasemboli ansås for at være meget lav, bør der indføres foranstaltninger til minimering af risikoen ved spraypåføring af disse lægemidler for at garantere sikker anvendelse af dem.
English: • the company for Tisseel, Tissucol and Artiss should ensure that these products are used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and which have labels stating the recommended pressure and distance;
Danish: • den virksomhed, der markedsfører Tisseel, Tissucol og Artiss, sikrer, at disse produkter anvendes med trykregulatorer, der ikke afgiver højere tryk end det maksimale nødvendige tryk til spraypåfø ring af fibrinklæberen, og som er forsynet med mærkater med de anbefalede værdier af tryk og af stand,
English: Following cases of gas embolism (presence of a gas bubble in the blood that affects the blood flow) reported in association with the use of Evicel and Quixil, in May 2012 the European Commission asked the CHMP to issue an opinion on whether the marketing authorisation for Evicel should be maintained,
Danish: Efter indberetninger om tilfælde af gasemboli (gasbobler i blodet, der nedsætter blodgennemstrømningen) ved anvendelse af Evicel og Quixil anmodede Europa-Kommissionen i maj 2012 CHMP om at fremsætte en udtalelse om, hvorvidt markedsføringstilladelsen for Evicel burde opretholdes, ændres, suspenderes eller inddrages i hele EU.
English: The fibrin then aggregates (sticks together) and forms a fibrin clot that helps the wound to heal, stopping the bleeding.
Danish: Fibrinet klumper derefter sammen til en fibrinklump, der medvirker til sårets heling ved at standse blødningen.
English: Questions and answers on the review of the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names) given by spray application
Danish: Spørgsmål og svar om gennemgangen af fibrinklæberne Tisseel, Tissucol, Artiss og Beriplast P (og relaterede navne), givet som spray
English: These include Quixil, Tisseel, Tissucol, Artiss and Beriplast P (and associated names).
Danish: Disse er Quixil, Tisseel, Tissucol, Artiss og Beriplast P (og relaterede navne).
English: The current conclusions concern Tisseel, Tissucol, Artiss and Beriplast P (and associated names).
Danish: De her givne konklusioner vedrører Quixil, Tisseel, Tissucol, Artiss og Beriplast P (og relaterede navne).
English: (Invented) name
Danish: (Sær)navn
English: 30 x 1 tablets (unit dose)
Danish: 30 × 1 tabletter (enkeltdosis)
English: Strength Pharmaceutical Form
Danish: Lægemiddelform Administrationsvej Emballage
English: Some patients have actually committed suicide.
Danish: Nogle patienter har faktisk begået selvmord.
English: ** based on historical comparison
Danish: ** Baseret på historisk sammenligning.
English: Do not add more food.
Danish: Tilsæt ikke mere mad.