FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP is still reviewing four other fibrin sealants: Tisseel, Tissucol, Artiss and Beriplast P (and associated names).
Danish: CHMP er stadig i færd med at gennemgå fire andre fibrinklæbere: Tisseel, Tissucol, Artiss og Beriplast P (og relaterede navne).
English: Other fibrin sealants in the EU are authorised nationally and these include Quixil, Tisseel, Tissucol, Artiss and Beriplast P (and associated names).
Danish: Andre fibrinklæbere i EU er godkendt nationalt, herunder Quixil, Tisseel, Tissucol, Artiss og Beriplast P (og relaterede navne).
English: The CHMP reviewed 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: 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 give fibrinklæbere ved spraypåføring.
English: The CHMP noted that fibrin sealants have the potential to be life-saving in certain circumstances, and that applying these medicines by spray is considered to be of benefit when there is a large surface area of bleeding during certain surgical procedures.
Danish: CHMP bemærkede, at fibrinklæbere kan være livsreddende under visse omstændigheder, og at det anses for en fordel at påføre disse lægemidler som spray, når der optræder blødning fra store overflader under operationer.
English: • the company for Evicel and Quixil should ensure that these products are used with pressure regulators that do not exceed the maximum pressure required to deliver the fibrin sealant, and that contain labels stating the recommended pressure and distance.
Danish: • at den virksomhed, der markedsfører Evicel og Quixil, sikrer, at disse produkter anvendes med trykregulatorer, hvis tryk ikke overstiger det maksimale nødvendige tryk til afgivelse af fibrinklæ beren, og som er påført mærkater med de anbefalede værdier af tryk og afstand.
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 nedsætte blødningen lokalt.
English: • Surgeons should note the potential risk of gas embolism with improper spray application of Evicel and Quixil 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 Evicel og Quixil og træffe de nødvendige forholdsregler som beskrevet i de opdaterede produktoplysninger for disse lægemidler,
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Evicel and Quixil continue to outweigh their risks, but that further risk minimisation measures should be implemented when these medicines are given by spray application to ensure that they are used correctly.
Danish: Efter vurdering af de aktuelt foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP, at fordelene ved Evicel og Quixil fortsat er større end risiciene, men at der bør indføres yderligere risikominimeringsforanstaltninger ved spraypåføring af disse lægemidler for at sikre, at de anvendes korrekt.
English: What are fibrin sealants?
Danish: Hvad af fibrinklæbere?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines given by spray application continue to outweigh their risks, but that appropriate measures have to be put in place to minimise the risk of gas embolism.
Danish: Agenturets udvalg for lægemidler til mennesker (CHMP) konkluderede, at fordelene ved lægemidler, givet ved spraypåføring, fortsat er større end risiciene, men at der bør træffes passende foranstaltninger for at nedsætte risikoen for gasemboli til et minimum.
English: • Evicel or Quixil application by spray should only be considered if it is possible to accurately judge the spraying distance.
Danish: • spraypåføring af Evicel eller Quixil må kun overvejes, hvis det er muligt at bedømme sprayafstanden nøjagtigt.
English: • Evicel and Quixil should be sprayed using CO2 only.
Danish: • Evicel og Quixil må kun spraypåføres ved hjælp af CO2,
English: These included changes to the product information to specify the maximum spray pressure to use during application and the recommended distance from the tissue surface.
Danish: angivet det maksimale spraytryk, der må anvendes ved påføringen, og den anbefalede afstand fra vævsoverfladen.
English: • Spraying Evicel or Quixil in endoscopic surgery is contraindicated.
Danish: • Evicel og Quixil må ikke spraypåføres ved endoskopiske operationer,
English: It has been authorised in 24 EU Member States.
Danish: Det har været godkendt i 24 EUmedlemsstater.
English: There is no evidence that this situation is evolving.
Danish: Der er ingen evidens for, at denne situation er ved at ændre sig.
English: The symptoms disappeared within 5 to 8 days without interruption of the treatment.
Danish: Symptomerne forsvandt inden for 5 til 8 dage uden afbrydelse af behandlingen.
English: Contact with skin and eyes should be avoided.
Danish: Kontakt med hud og øjne skal undgås.
English: Vet Q. 1988 Jul;10(3):191-7
Danish: Hun Vet Q. 1988 Jul;10(3):191-7
English: The first marketing authorisation was granted in 1972.
Danish: Den første markedsføringstilladelse blev udstedt i 1972.
English: The referral leads to full harmonisation of the product information.
Danish: Henvisningen fører til fuldstændig harmonisering af produktinformationen.
English: Hungary Zoetis Hungary Kft. Alkotás u. 53.
Danish: Zoetis Hungary Kft. Alkotás u. 53.
English: H-1123 Budapest Hungary
Danish: H-1123 Budapest Ungarn
English: Do not use this veterinary medicinal product after the expiry date which is stated on the bottle or bag.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på flasken eller posen.
English: The recommended dosage rates are:
Danish: De anbefalede doseringer er:
English: Postępu 17B 02-676 Warszawa Poland
Danish: Postępu 17B 02-676 Warszawa Polen
English: The oral absorption of lincomycin was found to be 53% ± 19%.
Danish: Oral absorption af lincomycin var 53% ± 19%.
English: In general mixture with other medicines should be avoided.
Danish: Generelt skal blanding med andre lægemidler undgås.
English: Moreover the harmonised dosing regimen is the one recommended in a vast majority of the Member States.
Danish: Desuden er det harmoniserede dosisregime det, der anbefales i langt størstedelen af medlemsstaterne.
English: * The restriction of the indications to those that are adequately substantiated by efficacy data;
Danish: • begrænsning af indikationerne til dem, der er tilstrækkeligt underbygget med data om virkning,
English: Treatment is symptomatic.
Danish: Behandlingen er symptomatisk.
English: A fresh solution should be prepared each day.
Danish: Der skal tilberedes en frisk opløsning hver dag.
English: * The deletion of all recommendations for prophylactic use;
Danish: • sletning af alle anbefalinger om profylaktisk anvendelse,
English: Plasmid-mediated resistance is less common.
Danish: Plasmid-medieret resistens forekommer mindre hyppigt.
English: Overall summary of the scientific evaluation of LincoSpectin 100 and its associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af LincoSpectin 100 og relaterede navne (se bilag I)
English: Denmark Zoetis Finland Oy Tietokuja 4
Danish: Zoetis Finland Oy Tietokuja 4
English: B-2870 Puurs Belgium
Danish: B-2870 Puurs Belgien
English: Via Andrea Doria, 41 M 00192 Roma Italy
Danish: Via Andrea Doria, 41 M 00192 Roma Italien
English: Regarding B. hyodysenteriae, including the points already mentioned, several issues were identified:
Danish: Vedrørende B. hyodysenteriae blev der fundet en række problemer, herunder de allerede nævnte:
English: EC4A 3AE London United Kingdom
Danish: EC4A 3AE London
English: Cmax occurred at 4 hours after introduction of the medicated water.
Danish: Cmax forekom 4 timer efter introduktion af det medicinerede vand.
English: Treatment should be initiated as soon as first clinical signs occur.
Danish: Behandlingen skal initieres, så snart de første kliniske tegn forekommer.
English: de Europa 20B Parque empresarial La Moraleja 28108 Alcobendas, Madrid Spain
Danish: de Europa 20B Parque empresarial La Moraleja 28108 Alcobendas, Madrid Spanien
English: The recommended harmonised dosing regimens do not lead to increased exposure of the environment to the active substances.
Danish: De anbefalede harmoniserede dosisregimer fører ikke til øget eksponering af miljøet for de aktive stoffer.
English: This might be due partly to natural resistance.
Danish: Dette kan delvis skyldes naturlig resistens.
English: This evaluation focuses on issues in regards to the harmonisation that may change the benefit-risk balance.
Danish: Vurderingen fokuserer på de punkter vedrørende harmoniseringen, som kan ændre benefit/riskforholdet.
English: and/or E. coli in chickens.
Danish: og/eller E. coli hos kyllinger.
English: Moreover L. intracellularis, like Brachyspira spp.
Danish: Desuden er L. intracellularis ligesom Brachyspira spp.
English: 150 g of powder = 100 g antibiotic activity should be diluted in…
Danish: 150 g pulver = 100 g antibiotisk aktivitet skal fortyndes i…
English: Do not use in case of hepatic dysfunction.
Danish: Bør ikke anvendes i tilfælde af hepatisk dysfunktion.
English: SPECIAL STORAGE CONDITIONS Do not store above 25 °C.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 25°C.
English: Also, as the dosing regimens and indications have not been extended, there is no change in the assessment of user safety.
Danish: Da doseringsregimer og indikationer ikke er blevet udvidet, er der desuden ingen ændring i vurderingen af sikkerheden for brugeren.
English: Rivium Westlaan 74, 2909 LD Capelle a/d Ijssel The Netherlands
Danish: Rivium Westlaan 74, 2909 LD Capelle a/d Ijssel Holland
English: There is often complete cross-resistance between lincomycin and clindamycin.
Danish: Der er ofte fuldstændig krydsresistens mellem lincomycin og clindamycin.
English: The average of the half-lives of elimination of all routes of administration is 2.82 hours in pigs.
Danish: Den gennemsnitlige halveringstid for alle administrationsveje er 2,82 timer hos svin.
English: Zoetis UK Limited 5th Floor, 6 St. Andrew Street
Danish: Storbritannien Zoetis UK Limited 5th Floor, 6 St. Andrew Street
English: Wash hands and any exposed skin with soap and water immediately after use.
Danish: Vask hænder og eksponeret hud med sæbe og vand straks efter anvendelse.
English: Human and animal bacteria share the same resistance determinants.
Danish: Bakterier hos mennesker og dyr har de samme resistensdeterminanter.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE To be completed nationally.
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG Udfyldes nationalt.
English: In the challenge study the bacterial infection seemed to be eradicated.
Danish: I belastningsundersøgelsen syntes den bakterielle infektion at blive udryddet.
English: MANUFACTURER'S BATCH NUMBER Lot:
Danish: FREMSTILLERENS BATCHNUMMER Lot
English: Consumer safety remains ensured by the recommended harmonised withdrawal periods of 0 days in pig and 5 days in chickens.
Danish: Forbrugernes sikkerhed er fortsat sikret med de anbefalede harmoniserede tilbageholdelsestider på 0 dage for svin og 5 dage for kyllinger.
English: The repeated or prolonged use should be avoided, by improving the farm management and disinfection practices.
Danish: Gentagen eller langvarig anvendelse skal undgås ved optimering af bedriftspraksis og desinfektionspraksis.
English: Medicated water should be removed every day and replaced by a new solution.
Danish: Al medicineret drikkevand, skal bortskaffes dagligt og erstattes af en ny opløsning.
English: Overall and considering also the older literature data, a rate of clinical resistance of at least 10% was suggested.
Danish: Samlet set og i betragtning af de ældre litteraturdata blev andelen af klinisk resistens anslået til mindst 10 %.
English: The combination might have a synergistic effect in Mycoplasma, but the clinical significance of this was not investigated.
Danish: Kombinationen kan tænkes at have synergistisk virkning på Mycoplasma, men den kliniske betydning heraf var ikke undersøgt.
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal product, animal species, route of administration, marketing authorisation holders in the Member States
Danish: Oversigt over navne, lægemiddelform, styrker af veterinærlægemidlet, dyrearter, indgivelsesvej, indehaver af markedsføringstilladelsen i medlemslandene
English: Poultry: for administration as the sole daily source of drinking water until consumed, followed by non-medicated water for the rest of the day, if necessary
Danish: Fjerkræ: til administration som eneste adgang til drikkevand, indtil det er konsumeret, om nødvendigt efterfulgt af ikkemedicineret vand resten af dagen
English: Animals must not be slaughtered for human consumption during treatment.
Danish: Dyr må ikke slagtes til konsum under behandlingen.
English: Lincomycin is excreted in milk.
Danish: Lincomycin udskilles i mælk.
English: The overall benefit-risk balance of the product for use in pigs and chickens was deemed positive subject to the recommended changes in the product information (see Annex III).
Danish: Det overordnede risk/benefit-forhold for produktets anvendelse hos svin og kyllinger fandtes positivt under forudsætning af de anbefalede ændringer af produktoplysningerne (se bilag III).
English: A symptomatic treatment must be implemented.
Danish: Der skal implementeres symptomatisk behandling.
English: Volume (L) for 150 g of the veterinary medicinal product
Danish: Volumen (l) til 150 g veterinærlægemiddel
English: In the proposed harmonised SPC all references to prophylactic treatment were deleted, which was confirmed by the CVMP.
Danish: I det ansøgte harmoniserede produktresumé blev al omtale af forebyggende behandling slettet, hvilket bekræftedes af CVMP.
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Danish: Da der ikke foreligger undersøgelser vedrørende eventuelle uforligeligheder, bør dette veterinærlægemiddel ikke blandes med andre veterinærlægemidler.
English: In the event of overdose in pigs, a change in the consistency of the faeces (soft faeces and/or diarrhoea) may be observed.
Danish: I tilfælde af en overdosis hos svin kan der observeres en ændring i konsistensen af fæces (blød fæces og/eller diarré).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION To be completed nationally.
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Udfyldes nationalt.
English: Similar results were observed following single oral doses of 4.4 and 11.0 mg/kg body weight in pigs.
Danish: Lignende resultater blev observeret efter orale enkeltdoser på 4,4 og 11,0 mg/kg legemsvægt hos svin.
English: Ireland Pfizer Healthcare Ireland Trading as Pfizer Animal Health,
Danish: Pfizer Healthcare Ireland Trading as Pfizer Animal Health,
English: Old tolerance studies are available for pigs, chickens and turkeys.
Danish: Der foreligger ældre toleranceundersøgelser for svin, kyllinger og kalkuner.
English: The combination showed beneficial effects as regards lesion reduction and zootechnical endpoints, and bacterial shedding was completely stopped.
Danish: Kombinationen viste gavnlig virkning i form af reduktion af forandringer og zootekniske endepunkter, og bakterieudskillelsen ophørte fuldstændig.
English: However, the CVMP considered the indication for B. hyodysenteriae should be maintained, taking into account the scope of this Article 34 referral procedure.
Danish: CVMP fandt imidlertid, at indikationen for B. hyodysenteriae burde opretholdes i betragtning af omfanget af denne artikel 34-indbringelse.
English: In E. coli and Salmonella spp.
Danish: MIC-distributionen for E. coli og Salmonella spp.
English: MLS antimicrobials are listed by WHO (AGISAR, 2009)3 as critically important for the treatment of certain zoonotic infections in humans (such as Campylobacter infections).
Danish: MLS-antibiotika er ifølge WHO (AGISAR, 2009)3 kritisk vigtige for behandlingen af visse zoonotiske infektioner hos mennesker (såsom infektioner med Campylobacter).
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substances:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Aktive stoffer:
English: However, again no firm breakpoint has been established.
Danish: Igen er der imidlertid ikke fastlagt en tærskelværdi.
English: Allergic/hypersensitive reactions are rare but can occur and require stopping treatment with the veterinary medicinal product.
Danish: Allergiske reaktioner/overfølsomhedsreaktioner er sjældne, men kan forekomme og kræver afbrydelse af behandling med veterinærlægemidlet.
English: Resistance can be a direct concern when affecting zoonotic pathogens such as Campylobacter and Enterococcus, or can be transferred horizontally to human pathogens via mobile genetic elements.
Danish: Resistens kan være et direkte problem, når den omfatter zoonotiske patogener som Campylobacter og Enterococcus eller kan overføres horisontalt til humanpatogener via mobile genetiske elementer.
English: This could be partly related to natural resistance in those bacterial species.
Danish: Dette kan delvis hænge sammen med naturlig resistens hos disse bakteriearter.
English: Belgium referred the issue due to divergent national decisions having been taken by the EU Member States resulting in discrepancies in the product information for Linco-Spectin 100 and its associated names.
Danish: Belgien indbragte sagen, fordi der som følge af divergerende nationale afgørelser er uoverensstemmelse mellem produktinformationerne i de forskellige EU medlemsstater for LincoSpectin 100 og relaterede navne.
English: In case of accidental overdose, the treatment should be interrupted and restarted at the recommended dose.
Danish: I tilfælde af overdosis ved hændeligt uheld, skal behandlingen afbrydes og reinitieres med den anbefalede dosis.
English: On 28 September 2012, Belgium sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Linco-Spectin 100 and its associated names.
Danish: Den 28. september 2012 foretog Belgien i medfør af artikel 34, stk. 1, i direktiv 2001/82/EF, som ændret, en indbringelse for CVMP/Det Europæiske Lægemiddelagentur vedrørende Linco-Spectin 100 og relaterede navne.
English: In pigs, lincomycin is rapidly absorbed following oral administration.
Danish: Hos svin bliver lincomycin absorberet hurtigt efter peroral administration.
English: Pringle et al. (2012)1 have proposed an epidemiological cut-off of >1 μg/ml for lincomycin, with which 90 to 100% of the isolates are classified as “resistant in vitro”.
Danish: Pringle et al. (2012)1 har foreslået en epidemiologisk tærskelværdi på >1 μg/ml for lincomycin, hvorved 90-100 % af isolaterne klassificeres som “resistente in vitro”.
English: Lincomycin resistance mediated by efflux pumps, or by inactivating enzymes, has also been described.
Danish: Lincomycinresistens, der er medieret af efflux-pumper eller af inaktiverende enzymer, er ligeledes beskrevet.
English: Possible resistance generated by lincomycin use in animals may impact animal health, including through cross-resistance with macrolides.
Danish: Eventuel resistens, der frembringes ved anvendelse af lincomycin til dyr, kan påvirke dyrs sundhed, herunder gennem krydsresistens med makrolider.
English: If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.
Danish: Hvis du bemærker alvorlige bivirkninger eller andre bivirkninger, som ikke er omtalt i denne indlægsseddel, bedes du kontakte din dyrlæge.
English: Studies performed in various animal species have demonstrated that spectinomycin undergoes limited absorption from the intestine (less than 4-7%) after oral administration.
Danish: Studier udført med forskellige dyrearter har vist, at spectinomycin gennemgår en begrænset absorption fra tarmen (mindre end 4-7%) efter peroral administration.
English: The combination of lincosamides and macrolides is antagonistic, due to competitive binding to their target sites.
Danish: Kombinationen af lincosamider og makrolider er antagonistisk på grund af kompetitiv binding til deres virkningssted.
English: and against some gram-negative bacteria such as E. coli.
Danish: og visse gram-negative bakterier såsom E. coli.
English: Shelf life after dilution according to directions: 24 hours.
Danish: Opbevaringstid efter fortynding ifølge anvisning: 24 timer.
English: Although in those studies doses were expressed as concentrations in drinking water so that actual doses in terms of mg/kg bw could only be estimated, the estimations were deemed sufficiently close to the recommended regimen.
Danish: Da doserne i disse undersøgelser blev angivet som koncentration i drikkevandet, kunne de faktiske doser i mg/kg kropsvægt kun anslås, men de anslåede værdier blev fundet at ligge tilstrækkelig tæt på det anbefalede regime.
English: This benefit-risk evaluation is performed in the context of Article 34 of Directive 2001/82/EC, which in the present procedure has the purpose of obtaining harmonisation within the EU of the conditions of authorisation for the product Linco-Spectin 100 (and associated names).
Danish: Denne benefit/risk-vurdering finder sted i sammenhæng med artikel 34 i direktiv 2001/82/EF og har i denne procedure til formål at harmonisere godkendelsesbetingelserne i EU or Linco-Spectin 100 (og relaterede navne).
English: A single oral dose of 10 mg/kg body weight was administered to pigs to determine the bioavailability.
Danish: En oral enkeltdosis på 10 mg/kg legemsvægt blev administreret til svin for at bestemme biotilgængeligheden.
English: Any medicated water which is not consumed within 24 hours should be discarded.
Danish: Al medicineret vand, der ikke er konsumeret inden for 24 timer skal bortskaffes.
English: Shelf life of the veterinary medicinal product as packaged for sale: “to be completed nationally”.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: “udfyldes nationalt”.
English: Diagnosis should be reconsidered if improvement is not seen after 5 days.
Danish: Hvis der ikke ses bedring efter 5 dage, skal diagnosen revurderes.
English: Care should be taken not to raise and inhale any dust.
Danish: Der skal udvises forsigtighed, så støv ikke hvirvles op og inhaleres.
English: Particularly in chicken respiratory diseases, the availability of Linco-Spectin 100 could limit the use of other antimicrobials considered as more critical for animal and human health, e.g. fluoroquinolones.
Danish: Specielt ved luftvejssygdomme hos kyllinger kan rådigheden over Linco-Spectin 100 tænkes at begrænse brugen af andre antibiotika, der anses for mere kritiske for menneskers og dyrs sundhed, f.eks. fluorquinoloner.
English: and other atypical gut organisms, is probably dependent on conditions established in the gut by other bacteria.
Danish: og andre atypiske tarmorganismer antagelig afhængige af vilkår, der tilvejebringes af andre bakterier i tarmen.
English: Levels were detectable for 12 to 16 hours, with peak concentrations occurring at 4 hours.
Danish: Koncentrationerne var detekterbare i 12-16 timer, med maksimale koncentrationer efter 4 timer.